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EC number: 216-700-6 | CAS number: 1643-20-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
No studies are available for C12 AO, however data are available for C12-14 AO, which contains approximately 60-80% of the C12 AO with the remainder being analogues differing only in the carbon chainlength. Based on read-across to these studies, the substance is expected to be irritating to the skin and corrosive to the eyes of rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test material was evaluated for skin irritation to normal and abraded skin of eight New Zealand white rabbits as a 2 % aqueous solution. Observations were recorded at 24- and 72 h.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Abraded and non-abraded.
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 0.6 % AO in water - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- Eight
- Details on study design:
- TEST SITE
- Area of exposure: 1.5x2 inches
- % coverage: no data
- Type of wrap if used: test material applied to a plastic coverlet, secured in place using plastic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24 & 72 hrs
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- other: 1/8 animals had a score of 1 at 72 hrs
- Remarks on result:
- other: maximum score observed at 72 hrs = 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24 & 72 hrs
- Score:
- 0.125
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Maximum score at 24 h = 1
- Other effects:
- Throughout the treatment and observation period all animals appeared clinically normal. No evidence of pain was observed. All animals thrived and responded normally to external stimuli.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A 2 % solution of the test material caused slight erythema and occasional oedema on the abraded and non-abraded skin over the 72 h observation period. The 2 % solution of the test material (equivalent to 0.6 % AO) showed a primary irritation index of 0.93.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 24-05-1982 to 26-05-1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Federal Register, Vol. 41 (188): 42572 (27th September 1976). US CFR 49(173).
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w - Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
- Number of animals:
- Six
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- no data
- Other effects:
- No data
- Interpretation of results:
- other: Not corrosive
- Remarks:
- Criteria used for interpretation of results: other: US Federal Register.
- Conclusions:
- The study indicates that the test substance does not have a corrosive action on the skin following a 4 h exposure period.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 10-1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register Vol. 38 (187): 1500:41, 1973.
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: stated as 'recognised breeders'
- Age at study initiation: 12-14 weeks
- Weight at study initiation: average bw 2.15 kg
- Housing: caged singly
- Diet: Rank Hovis MacDougal rabbit diet, ad libitum
- Water: filtered water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 2
- Humidity (%): 50-70
- Air changes (per hr): not stated
- Photoperiod: natural lighting conditions - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 6.5 % as supplied - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 h
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 10 %
- Type of wrap if used: Smith & Nephew Elastic bandage (occlusive).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure:
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: mean of 25 & 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean of 24 & 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance gave a primary irritation score of 2.07 over 72 h which is classed as a moderate irritant to the skin of the rabbit according to the author of the study report. Based on EU classification criteria, the test substance is not classified as irritating to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 01-06-1981 to 03-06-1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register Vol. 41 (188): 42572 (27th September 1976). US CFR 49 (173).
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w - Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- no data
- Other effects:
- No data
- Interpretation of results:
- other: Not Corrosive
- Remarks:
- Criteria used for interpretation of results: other: US Federal Register
- Conclusions:
- No reactions were apparent at the 4 h observation. Well-defined erythema was apparent at all 6 treated sites at the 48 h observation and very slight oedema was apparent at 4 treated sites at this time. The test substance did not cause destruction of intact skin of the albino rabbit and based on this result would not be regarded as a corrosive agent according to the Definitions in the US Federal Register Test. The Class 8 classification of the UN Economics and Social Council was slightly corrosive.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978-02-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - Treatment time is 24 hours instead of 4 hours. 0.4ml of test substance dosed instead of 0.5ml. Systemic toxicity, body weight and histopathology results are not given.
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper's rabbit ranch, Gary, Indiana
- Age at study initiation: Not available
- Weight at study initiation: 2103 - 2781 gm
- Housing: Individually in hanging wire-mesh cages in temperature and humidity controlled quarters
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): As per S.O.P.
- Humidity (%): As per S.O.P.
- Air changes (per hr): As per S.O.P.
- Photoperiod (hrs dark / hrs light): As per S.O.P.
IN-LIFE DATES: 1978-02-22 - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 ml of test substance
- Concentration (if solution): Undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 0.4 ml of undiluted P7270 was applied to one abraded and one intact test site on each of the three New Zealand white rabbits (2 male and 1 female)
using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad secured with wrappings of 75 mm elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours. - Observation period:
- 24 and 72 hours
- Number of animals:
- 3 animals (2 male and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: Back of animals (intact and abraded skin site)
- % coverage: Test substance applied using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad
- Type of wrap if used: 75 mm elastoplast tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance removed with a damp cloth
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- in 72 hrs
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritant / corrosive response data:
- For Intact and Abraded skin site- PII at 24 hours: 2.0, PII at 72 hours: 8.0
- Other effects:
- One animal showed blanching at 24 hours at abraded skin site.
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- P7270 (28% DDAO) is classified as a Category 2 skin irritant according to EU GHS classification.
- Executive summary:
0.4 ml of undiluted P7270 (28% DDAO) was applied to one abraded and one intact test site on each of the three New Zealand white rabbits (2 male and 1 female) using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad secured with wrappings of 75 mm elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.
Occlusive 24 hour exposure to 0.4 ml of undiluted DDAO produced very slight erythema and very slight edema at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation (injuries in depth) and severe edema (raised more than 1 mm extending beyond the area of exposure) was served at the intact and abraded of all the test animals.
One animal showed blanching at 24 hours at abraded skin site.
Thus, 28% DDAO/ C10-C16 alkyldimethyl, N-Oxide is classified as a Category 2 skin irritant according to EU GHS classification.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-09-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - Treatment time is 24 hours instead of 4 hours. 0.4ml of test substance dosed instead of 0.5ml. Systemic toxicity, body weight and histopathology results are not given.
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kings wheel
- Age at study initiation: Not available
- Weight at study initiation: 2058.9 - 3285.9 gm
- Housing: Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purina lab rabbit chow
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: Minimum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4°C - 21.1°C
- Humidity (%): 72%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours on/off fluorescent lighting
IN-LIFE DATES: 1978-09-21 - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 ml of P0434
- Concentration (if solution): Undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 0.4 ml of undiluted P0434 was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits
using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and
72 hours. - Observation period:
- 24 and 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Back of animals (right side - abraded, left side - intact)
- % coverage: Test substance applied using Parke-Davis Readi-Bandage
- Type of wrap if used: Gauze and elastoplast tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites wiped with wet paper towel
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize method
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other:
- Remarks:
- intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- intact skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: intact skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.67
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 72 hours
- Remarks on result:
- other: abraded skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No edema was observed
- Remarks on result:
- other: abraded skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No edema was observed
- Remarks on result:
- other: abraded skin site
- Irritant / corrosive response data:
- For intact and abraded skin site at 24 hours PII is 1.67 and at 72 hours PII is 4.0.
- Other effects:
- None reported
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- P0434 (27.8% DDAO) is classified as a Category 2 skin irritant according to EU GHS classification.
- Executive summary:
0.4 ml of undiluted P0434 (27.8% DDAO) was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.
Very slight to well-defined erythema at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation (injuries in depth) were observed at the intact and abraded of all the test animals. No edema was observed at any time point.
Thus, 27.8% DDAO/ C10-C16 alkyldimethyl, N-Oxide is classified as a Category 2 skin irritant according to EU GHS classification.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA/CPSC Design, 16 CFR 1500
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: no data
- Housing: individually housed in stainless steel cages
- Diet: Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidy and light were controlled according to the receommendations contained in DHEW Publication No. 86-23 (NIH) Guide for the Care and Use of Laboratory Animals - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved + abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 5 % active or 2.5 % active in aqueous solution as supplied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 3 animals per dose level
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: not stated
- Type of wrap if used:Site was covered with a two layer gauze patch secured with non-irritating porous adhesive tape and the entire site was wrapped with a 4 mil plastic wrap and secured with more tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material was removed from the site (method not specified)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average of 24 & 72 hours scores
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 5 % AO solution
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average of 24 & 27 hour scores
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 2.5 % AO Solution
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 2.5 % AO Solution
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 2.5 % AO Solution
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 2.5 % AO Solution
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 2.5 % AO Solution
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average of 24 & 72 hour scores
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 2.5 % AO Solution
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study solutions containing C12-14 amine oxide at 2.5 or 5 %w/w were not irritating to the skin of rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 24-05-1982 to 26-05-1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register Vol. 41 (188): 24572 (27th September 1976). US CFR 49 (173).
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w - Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
- Number of animals:
- 6 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the 48 h observation period.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the 48 h observation period
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Other effects:
- No data
- Interpretation of results:
- other: Not corrosive
- Remarks:
- Criteria used for interpretation of results: other: US Federal Register
- Conclusions:
- Slight erythema was apparent at 4 of the 6 treated sites following a 4 h exposure to the test material. Slight increase in the observable reactions was apparent during the course of the study. No necrosis or other evidence of corrosive action was apparent during the study. The results indicate that the test material does not have a corrisive action on the skin following a 4 h exposure period.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Animal No. |
Skin site |
Degree of erythema after---- [Observation time] |
Degree of edema after---- [Observation time] |
Ø 24/72 h >= 2.3 but < 4.0 |
|||
|
|
24 h |
72 h |
24 h |
72 h |
Erythema |
Edema |
|
Intact |
|
|
|
|
|
|
30970 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
|||
30979 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
|||
31017 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
|||
|
Abraded |
|
|
|
|
|
|
30970 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
|||
30979 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
|||
31017 |
|
1 |
4 |
1 |
4 |
Yes |
Yes |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 2.5 |
=> Positive responder |
Animal No. |
Skin site |
Degree of erythema after---- [Observation time] |
Degree of edema after---- [Observation time] |
Ø 24/72 h >= 2.3 but < 4.0 |
|||
|
|
24 h |
72 h |
24 h |
72 h |
Erythema |
Edema |
|
Intact |
|
|
|
|
|
|
RB 608 78 |
|
1 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 0 |
=> Positive responder |
|||
RB 524 78 |
|
2 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 3.0 |
Ø 24/ 72 h = 0 |
=> Positive responder |
|||
RB 525 78 |
|
2 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 3.0 |
Ø 24/ 72 h = 0 |
=> Positive responder |
|||
|
Abraded |
|
|
|
|
|
|
RB 608 78 |
|
1 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 2.5 |
Ø 24/ 72 h = 0 |
=> Positive responder |
|||
RB 524 78 |
|
2 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 3.0 |
Ø 24/ 72 h = 0 |
=> Positive responder |
|||
RB 525 78 |
|
2 |
4 |
0 |
0 |
Yes |
No |
|
|
Ø 24/ 72 h = 3.0 |
Ø 24/ 72 h = 0 |
=> Positive responder |
Only the results from intact skin are used in the scoring
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 10-1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register Vol. 38 (187) 1500:42 (1973).
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.08 kg average
- Housing: caged singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17+/-2
- Humidity (%): 50-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting conditions - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 6 % AO - Duration of treatment / exposure:
- Group 1: Eyes remained unwashed for the 72 h test period
Group 2: 5 sec - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Group 1: Six
Group 2: Three - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1 - no washing; Group 2 - 20 mL sterile distilled water at 37°C
- Time after start of exposure: Group 2 - 5 seconds
SCORING SYSTEM: Draize - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 & 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: max score for single animal = 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 & 72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: max score for single animal = 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean o f24, 48 & 72 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 4 animals score >=2.7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean o f24, 48 & 72 hours
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: 3 animals score >=2.3
- Other effects:
- No data
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study the 6 % solution of amine oxide was irritating to the eyes of rabbits.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978-05-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Age at study initiation: Not available
- Weight at study initiation: 2002 To 2940 gms
- Housing:Individually in hanging wire mesh cages
- Diet (e.g. ad libitum): Purinaw rabbit Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.), entitled"Guide for the care and Use of Laboratory Animals"
- Humidity (%): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),
- Air changes (per hr): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),
- Photoperiod (hrs dark / hrs light):In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),
IN-LIFE DATES: From: To: - Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml P7270
- Concentration (if solution): Undiluted P7270 applied to the Group I and II, while a 10% (w/w) aqueous solution P7270 was applied to Group III
VEHICLE
- Amount(s) applied (volume or weight with unit): distilled water (for Group III)
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- Group I: 0.1 ml of undiluted P7270 was applied and eyes were not rinsed.
Group II: 0.1 ml of undiluted P7270 was applied and eyes were rinsed with 20 ml lukewarm water approximately for 4 seconds following dosing.
Group III: 0.1 ml of a 10% (w/w) solution of P7270 in distilled water was applied and eyes of animals were not rinsed. - Observation period (in vivo):
- After application of test material: 1 hour, 1,2,3,4,7,14,21,28 and 35 days.
- Number of animals or in vitro replicates:
- 3 rabbits of either sex per group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes of animals in Group II were rinsed with 20 ml lukewarm water
- Time after start of exposure: approximately for 4 seconds following dosing
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 6.67
- Max. score:
- 6.67
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- One animal with grade 1.5 and two with grade 0
- Time point:
- other: 1 hour
- Score:
- > 1 - < 1.5
- Max. score:
- 1.5
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals with grade 1
- Time point:
- other: 1 hour, 1 day, 2 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- One animal with grade 2, one with grade 1.5 and one with grade 1
- Time point:
- other: 1 hour
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals with grade 3
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 7.67
- Max. score:
- 7.67
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- two animals with grade 2 and one with grade 1
- Time point:
- other: 1 day
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- two animals with grade 2 and one with 1.5
- Time point:
- other: 1 day
- Score:
- > 1.5 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- two animals with grade 3 and one with grade 3.5
- Time point:
- other: 1 day
- Score:
- > 3 - < 3.5
- Max. score:
- 3.5
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 7.17
- Max. score:
- 7.17
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- one animal with grade 2 and two with grade 1
- Time point:
- other: 2 days
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- one animal with grade 2 and two with grade 1.5
- Time point:
- other: 2 days
- Score:
- > 1.5 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- two animals with grade 3 and one with grade 3.5
- Time point:
- other: 2 days
- Score:
- > 3 - < 3.5
- Max. score:
- 3.5
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 7.83
- Max. score:
- 7.83
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- one animal with grade 2, one with 1.5 and one with grade 1
- Time point:
- other: 3 days
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- two animals with grade 1 and one with grade 2
- Time point:
- other: 3 and 4 days
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- one animal with grade 2.5, one with 2 and one with grade 1.5
- Time point:
- other: 3 days
- Score:
- > 1.5 - < 2.5
- Max. score:
- 2.5
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- one animal with grade 2.5, one with 3 and one with grade 3.5
- Time point:
- other: 3 days
- Score:
- > 2.5 - < 3.5
- Max. score:
- 3.5
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- one animal with grade 3, one with 1.5 and one animal with grade 1
- Time point:
- other: 4 days
- Score:
- > 1 - < 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Group I: 0.1 ml undiluted test substance, no rinse
- Irritant / corrosive response data:
- Group I: Irreversible irritation upto day 35.
Group II: Irriversible irritation upto day 35.
roup III: All signs of irritation were reversed within 21 days. - Other effects:
- Death of one animal of Group III. And the cause of death of animal was unable to determine.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Undiluted P7270 (28% dodecyl dimethyl amine oxide) causes irreversible irritation to rabbit eyes.
- Executive summary:
The eyes of three groups of 3 rabbits were instilled with 0.1 ml of P7270 (28% dodecyl dimethyl amine oxide). Group I and II received undiluted P7270 while group III animals were treated with a 10% aqueous solution of P7270 in distilled water. The eyes of the Group I and Group III rabbits were not rinsed and the eyes of the Goup II rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 ml of lukewarm distilled water.
Group I: The maximum average score was 8.0 on 4th day. The observable response included irreversible corneal opacity in all three animals till 35 days, iridic response with grade 1 was observed, conjunctival redness upto grade 2 was observed and conjunctival chemosis upto grade 3(swelling with lids about half closed) was observed. The reactions were not fully reversed till 35 days.
Group II: The maximum average score was 6.0 on 3rd day. The observable response included irreversible corneal opacity in one animal till 35 days, iridic response upto grade 1 was observed,conjunctival redness upto grade 2.5 (more diffuse beefy red areas) was observed and conjunctival chemosis upto grade 2.5 was observed which was no fully reversed within 35 days.
Group III: The maximum average score was 4.8 on 2nd day. The observable response included corneal opacity which was reversed within 7 days, iridic response upto grade 1 was observed,conjunctival redness upto grade 2 (more diffuse crimson red areas) was observed and conjunctival chemosis upto grade 2 was observed. All reactions were fully reversed within 21 days in all animals. In this group one rabbit was found dead and the cause of death was unable to determine.
From these observations it can be concluded that P7270 caused irreversible irritation to the rabbit eye. Thus P7270 (28% DDAO) can be classified as GHS category 1.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-09-12 To 1978-10-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kings Wheel
- Age at study initiation: Young adult
- Weight at study initiation: Males: 1608.6 gm, Females: 2031.5 gm
- Housing:Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purins Lab Rabbit Chow (By Ralston Purina Company)
- Water (e.g. ad libitum): Tap water, from bottles with tubules made of refined steel, ad libitum
- Acclimation period: minimum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 46-72
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12/12 (Fluorescent lighting)
IN-LIFE DATES: From: 1978-09-12 To: 1978-10-18 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml P0434
- Concentration (if solution): Undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- GroupI: Eyes of animals were not rinsed, and observations are noted directly.
Group II: Eyes of animals were rinsed after 4 seconds by spraying 20 ml of lukewarm tap water after application. - Observation period (in vivo):
- At 1 hour, 1,2,3,4,7,14,21,28 and 35 days.
- Number of animals or in vitro replicates:
- 3 animals of either sex per group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes of Group II animals were rinsed by spraying 20 ml of lukewarm tap water from a hypodermic syringe fitted with a snubbed 18 gauge needle into the eye under moderate pressure.
- Time after start of exposure: 4 seconds after application.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: A Pen light - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2.67
- Max. score:
- 2.67
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- All animals with grade 0
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour, 1,2,3,4,7,14,21,28 and 35 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No iridal response was observed at any time interval
- Remarks on result:
- other: No rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- All animals with grade 1
- Time point:
- other: 1 hour, 1,2,3,4,7 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Two animals with grade 2 and one with grade 1
- Time point:
- other: 1 hour
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 1
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- All animals with grade 1
- Time point:
- other: 1,2,3,4,7,14 and 21 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- All animals with grade 2
- Time point:
- other: day 1
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 2,3
- Score:
- 3.33
- Max. score:
- 3.33
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- One animal with grade 2 and two with grade 1
- Time point:
- other: day 2, 3
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 4
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- One animal with grade 2, one with grade 1 and one with grade 0
- Time point:
- other: day 4
- Score:
- > 0 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 7
- Score:
- 2.67
- Max. score:
- 2.67
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Two animals with grade 1 and one with grade 0
- Time point:
- other: day 7
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: days 14, 21
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- other: Conjunctivae and chemosis score
- Basis:
- mean
- Remarks:
- All animals with grade 0
- Time point:
- other: 14, 21, 18 and 35 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 28 and 35 days
- Score:
- 1.67
- Max. score:
- 1.67
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Two animals with grade 2 and one with grade 1
- Time point:
- other: 28 and 35 days
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: No rinse
- Other effects:
- None
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- P0434 (27.8% Dodecyl dimethyl amine oxide) causes irreversible irritation to the rabbit eye.
- Executive summary:
The eyes of two groups of 3 rabbits were instilled with 0.1 ml of undiluted P0434 (27.8% DDAO). The eyes of the first group of 3 rabbits were not rinsed and the eyes of the second group of 3 rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 ml of lukewarm distilled water.
Group I:The maximum average score was 4.0 at 1day. The observable response included irreversible corneal opacity in all three animals till 35 days, no iridic response was observed, conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis upto grade 2 was observed which was fully reversed within 14 days.
Group II: The maximum average score was 3.67 at one day. The observable response included irreversible corneal opacity in one animal till 35 days, no iridic response was observed,conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis upto grade 2 was observed which was fully reversed within 2 days.
From these observations it can be concluded that the test material P0434 (27.8% dodecyl dimethyl amine oxide) is causing irreversible irritation to the rabbit eye. Thus 27.8% DDAO can be classified as GHS category 1.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Samples were administered into one eye each of three albino rabbits per test article. The eyes were observed and scored at 1, 24, 48, 72 and 168 hours.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: no data
- Housing: individually housed in stainless steel cages
- Diet: Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: At least 4 days
ENVIRONMENTAL CONDITIONS
The rabbits were maintained according to the recommendations contained in the DHEW Publication No. 86.23 (NIH): 'Guide for the care and Use of Laboratory Animals'. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The conlateral eye served as the untreated control for each rabbit
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 5% AO (Agent 2108-87-5) 2.5% AO (Agent 2108-87-6) - Duration of treatment / exposure:
- Eyes of animals were not rinsed, and observations are noted directly.
- Observation period (in vivo):
- 1, 24, 48, 72 and 168 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Eyes of animals were not rinsed
SCORING SYSTEM: Draize, JH (1965). Appraisal of the saftey of chemicals in foods, drugs and cosmetics
TOOL USED TO ASSESS SCORE: 2% fluorescein AND uv light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 19.4
- Max. score:
- 80
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 21.6
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 5
- Max. score:
- 10
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3.3
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 13.3
- Max. score:
- 20
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 11.3
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 5 % AO
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 16.1
- Max. score:
- 80
- Remarks on result:
- other: 2.5 % AO
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 16.7
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 &72 hours
- Score:
- 5
- Max. score:
- 10
- Remarks on result:
- other: 2.5 % AO
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3.3
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 2.5 % AO
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 12.8
- Max. score:
- 20
- Remarks on result:
- other: 2.5 % AO
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 6.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 2.5 % AO
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Referenceopen allclose all
Overall irritation/ Corrosion results: For Rinse Group
Irritation parameter | Basis | Time point | Max.score | Reversibility | Remarks | |
Overall irritation score | mean | 1 hour | 3.0 | 3.0 | not fully reversible within:35 days | Rinse |
Cornea score | mean: all animals with grade 0 | 1 hour | 0 | 0 | not fully reversible within:35 days | Rinse |
Iris score | 1 hour, 1,2,3,4,7,14,21,28 and 35 days | 0 | 0 | No iridal response was observed. | Rinse | |
Conjunctival redness score | mean: all animals with grade 1 | 1 hour, 1,2,3,4 and 7 days | 1 | 1 | fully reversible within:14 days | Rinse |
Conjunctival chemosis score | mean | 1 hour and day 1 | 2 | 2 | fully reversible within: day 2 | Rinse |
Overall irritation score | mean | day 1 | 3.67 | 3.67 | not fully reversible within:35 days | Rinse |
Cornea score | mean: Two animals with grade 1 and one with grade 0 | day 1,2,3,4 | >0 -<1 | 1 | not fully reversible within:35 days | Rinse |
Overall irritation score | mean | days 2,3,4 | 1.67 | 1.67 | not fully reversible within:35 days | Rinse |
Conjunctival chemosis score | mean: all animals with grade 0 | days 2,3,4,7,14,21,28 and 35 days | 0 | 0 | fully reversible within:2 days | Rinse |
Overall irritation score | mean | day 7 | 1.33 | 1.33 | not fully reversible within:35 days | Rinse |
Cornea score | mean:one animal with grade 1 and two with grade 0 | day 7, 14 | >0 - <1 | 1 | not fully reversible within:35 days | Rinse |
Conjunctival redness score | mean:all animals with grade 0 | day 14,21,28 and 35 | 0 | 0 | fully reversible within:14 days | Rinse |
Overall irritation score | mean | day 14, 21,28 and 35 | 0.33 | 0.33 | not fully reversible within:35 days | Rinse |
Cornea score | mean:one animals with grade 1 and two with grade 0 | day 14, 21, 28 and 35 | >0 - <1 | 1 | not fully reversible within:35 days | Rinse |
GHS Classification:
Animal # | GHS Classification | What it means? | Cornea | Iris | Conjunctival redness | Conjunctival chemosis | Days to clear by individual animal |
No rinse (Group I) | |||||||
1 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 2.0 | Cornea not reversible by 35 days |
2 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 1.33 | Cornea not reveersible by 35 days |
3 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 1.33 | Cornea not reversible by 35 days |
Rinse (Group II) | |||||||
1 | 1 | Irreversible eye irritation | 0.0 | 0 | 1.0 | 0.67 | Fully reversible within 14 days |
2 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 0.67 | Fully reveersible within 14 days |
3 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 0.67 | Cornea not fully reversible by 35 days |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
No data are available for C12 AO, however data are available for C12 -14 AO which contains approximately 60 -80 % of C12 AO with the remainder being mostly higher chainlength analogues. Read-across to the results of these studies is considered to be appropriate.
In the key study, performed according to OECD TG 404 [Fulfs JC (1978)], C12 -14 AO (0.4 mL, 27.8 %AO) was applied to the intact and abraded skin of 3 female rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. At the end of the exposure period the treatment sites were wiped with a wet paper towel and reactions noted over a 72 hour period. Very slight to well defined erythema was observed at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation were observed at the intact and abraded sites of all test animals. No oedema was observed at any time point. Similar results were obtained in a supporting study [Dean WP (1978)].
In three further supporting studies, performed according to US Federal Register, vol 41(188): 42572 (27thSeptember 1976), C12 -14 AO (0.5 mL, 30 % AO) was applied to the intact skin of 6 rabbits (albino) and covered with an occlusive dressing for 4 hours. At the end of the exposure period the test substance was removed by wiping with a paper towel moistened with sterile distilled water. The sites were scored immediately and after 48 hours. Erythema and oedema scores increased during the 48 hour observation period. No destruction of intact skin was observed after the four hour exposure.
Three further studies are available performed using lower concentrations of C12 -14 AO. In the first of these [Nicholas P & Jones JR (1976)] performed according to US Federal Register Vol 38 (187): 1500:41 (1973) the substance (0.5 mL, 6 %w/w AO) was applied to the intact and abraded skin of 6 rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. Very slight to moderate to severe erythema and very slight to slight oedema was observed at the intact and abraded sites of all test animals at 24 hours. At 72 hours no to slight erythema and no to very slight oedema was observed at the intact and abraded sites of all test animals. In the second study the substance (0.5 mL, 0.6 % AO) was applied to the intact and abraded skin of 8 rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. No to very slight erythema and oedema was observed at the intact and abraded sites of all test animals at 24 and 72 hours. In the third study [Kukulinski M (1997)] performed according to FHSA/CPSC Design, 16 CFR1500 the substance (0.5 mL, 2.5 or 5 %AO) was applied to the intact and abraded skin of 3 rabbits (New Zealand White). At 5 % AO one rabbit had no erythema at 24 hours on had very slight and the third had well defined erythema at the intact sites. At 72 hours two rabbits had no erythema and the third very slight erythema. No oedema was observed at either 24 or 72 hours. At 2.5 % AO very slight erythema was observed in one rabbit at 24 hours. All other scores were zero at both 24 and 72 hours.
Eye irritation
No data are available for C12 AO, however data are available for C12 -14 AO which contains approximately 60 -80 % of C12 AO with the remainder being mostly higher chainlength analogues. Read-across to the results of these studies is considered to be appropriate.
In the key study, performed according to OECD TG 405 [Fulfs JC (1978)] C12 -14 AO (0.1 mL, 27.8 % AO) was instilled into the eyes of two groups of three rabbits (New Zealand White). The eyes of the first group of 3 rabbits were not rinsed and the eyes of the second group of 3 rabbits were rinsed, approximately 4 seconds following instillation of the test substance, with 20 ml of lukewarm distilled water. In the first group the maximum average score was 4.0 at one day. The observable response included irreversible corneal opacity in all three animals up to 35 days. No iridic response was observed. Conjunctival redness with grade 1 and conjunctival chemosis up to grade 2 were observed and fully reversed within 14 days. In the second group the maximum average score was 3.67 at one day. The observable response included irreversible corneal opacity in one animal up to 35 days. No iridic response was observed. Conjunctival redness with grade 1 and conjunctival chemosis up to grade 2 were observed and fully reversed within 2 days. From these observations it is concluded that the test substance caused irreversible damage to the rabbit eye.
In a supporting study performed according to OECD TG 405 [Dean WP (1978)] C12 -14 AO was instilled into the eyes of two groups of three rabbits (New Zealand White). Group I and Group II received 0.1 mL of 28 % AO. Group III received 0.1 mL of a 10 % dilution, i.e. 2.8 % AO. The eyes of the Group I and Group III rabbits were not rinsed and the eyes of the Group II rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 mL of lukewarm distilled water. For Group I the maximum average score was 8.0 on 4th day. The observable response included irreversible corneal opacity in all three animals till 35 days. Iridic response with grade 1 was observed. Conjunctival redness up to grade 2 was observed and conjunctival chemosis up to grade 3 (swelling with lids about half closed) was observed. The reactions were not fully reversed up to 35 days. For Group II the maximum average score was 6.0 on the third day. The observable response included irreversible corneal opacity in one animal up to 35 days. Iridic response up to grade 1 was observed. Conjunctival redness up to grade 2.5 (more diffuse beefy red areas) and conjunctival chemosis up to grade 2.5 were observed which were not fully reversed within 35 days. For Group III the maximum average score was 4.8 on the second day. The observable response included corneal opacity which was reversed within 7 days. Iridic response up to grade 1 was observed. Conjunctival redness up to grade 2 (more diffuse crimson red areas) and conjunctival chemosis up to grade 2 were observed. All reactions were fully reversed within 21 days in all animals. In this group one rabbit was found dead and the cause of death was unable to be determined. From these observations it can be concluded that the test substance at a concentration of 28 %AO caused irreversible damage to the rabbit eye. A 10 % dilution of the test substance (i.e. 2.8 % AO) caused irritation that was reversible within 21 days. Two further studies are available performed on lower concentrations of AO. In both of these studies, which used 6 % AO [Nicholas P & Jones JR (1976)] and 5 % or 2.5 % AO [Kukulinski M (1997)] the test substance induced eye irritation effects that were not fully reversible within a 7 -day period. It is not possible to conclude for certain from the 7 -day scores whether the effects would be fully reversed if the observation period had been extended to 21 days, however based on the study performed with 2.8 % AO this seems likely.
Justification for classification or non-classification
C12 AO is classified as Skin Irritant Category 2 on the basis of the reactions seen in the skin irritation studies performed on the read-across substance C12 -14 AO.
The read-across substance C12 -14 AO caused damage to the eyes of rabbits that did not fully reverse during the 21 day observation period. On this basis C12 AO is classified as Eye Damage Category 1.
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