Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-518-6 | CAS number: 37475-84-6
- 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
The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of DDBSA and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.
A study according to the OECD Guideline 404 was performed on the sodium salt of LAS. Irritation was noted in all animals at the first observation (maximum score of 2). Symptoms worsened, and desquamation, necrosis, and hyperkeratinization was noted by day 4. Symptoms resolved in one animal by day 12, but in the other two animals, symptoms were seen through the end of the observation period. The primary dermal irritation index was 2.17. The test substance is considered a Category 2 irritant according to EU GHS guidelines based on persistent irritation.
AMP was shown to cause skin irritation after repeated and single dermal exposure of rabbits.
Groups of three rabbits had 0.1 ml of DDBSA placed in each of their eyes (with and without rinsing). Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. An additional study was terminated after 6 days, because of the necrosis observed. DDBSA is considered to be severely iritating to the eyes.
In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeared to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- the tested substance is DDBSA one of the components of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- The shaved treated area (about 6 m2) was covered with gauze and covered by polyethylene film for the first 4 hours, at which time the test area was rinsed with warm water. Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hours.
- Score:
- 5.25
- Max. score:
- 6
- Reversibility:
- not reversible
- Remarks on result:
- other: highly irritating
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr readings
- Score:
- 5.33
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Other effects:
- Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Result: Highly irritating at 0.5 mL
- Executive summary:
The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the test substance and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- the tested substance is the sodium salt of DDBSA one of the components of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment tested on 47% formulation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.7-3.3 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: March 18, 1986 To: March 31, 1986 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml aliquot of P-500 N-Na
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- Hair was clipped from a 10 x 10 area of the dorsal-lumbar region. Test substance was applied under a gauze pad, and then covered with elastic adhesive dressing. Examination of the treated skin was made approximately 30 minutes after removal of the patch and daily through 14 days. Grading and scoring of the dermal reactions was performed using the standard numerical scoring system.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 2.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Well defined to moderate skin reactions were observed in all three animals following removal of the bandages. Desquamation of the stratum corneum was observed in all three animals. The reaction in all three animals gradually ameliorated from Days 5, 10 and 11, respectively, and had all resolved completely in one animal by Day 12.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance was moderately to severely irritating to skin, but effects were not fully reversible within 14 days. The test substance is a Category 2 irritant according to EU GHS guidelines based on persistent irritation.
- Executive summary:
This study was performed on three animals with a semi-occlusive application, according to the OECD Guideline 404 and GLP. LAS concentration as active matter was 47%. Three rabbits were exposed to 0.5 ml of the test substance dermally for 4 hours on clipped skin under a gauze pad held in place by an adhesive dressing. Examination of the treated skin was made approximately 30 minutes after removal of the patch and daily through 14 days. Grading and scoring of the dermal reactions was performed using the standard numerical scoring system. Irritation was noted in all animals at the first observation (maximum score of 2). Symptoms worsened, and desquamation, necrosis, and hyperkeratinization was noted by day 4. Symptoms resolved in one animal by day 12, but in the other two animals, symptoms were seen through the end of the observation period. The primary dermal irritation index was 2.17. The test substance is considered a Category 2 irritant according to EU GHS guidelines based on persistent irritation.
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vivo study preformed for this endpoint prior to perfection of in vitro assays. Data obtained from this study is considered accurate for determination of lack of corrosivity
- Type of information:
- experimental study
- Remarks:
- the tested substance is AMP one of the components of the compound
- Adequacy of study:
- supporting study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Methodology used was similar to guideline, no indication of GLP but reporting sufficient to assess the endpoint
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- The rabbit skin was evaluated only after four hours of exposure.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Conducted prior to GLP
- Species:
- rabbit
- Strain:
- other: Albino (no other data given)
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of test material as received
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- immediately after removal of occlusive dressing
- Number of animals:
- 6
- Irritation parameter:
- other: Corrosion
- Basis:
- mean
- Time point:
- other: 4 hours
- Remarks on result:
- other: Not Corrosive
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- AMP-95 and AMP regular are consided non-corrosive.
- Executive summary:
The skin corrosion potential of 2-amino-2-methyl-1-propanol (AMP) was studied extensively in 1975 when the US
Department of Transportation "harmonized" its classification criteria with those recommended by the UN experts.
At that time GLP requirements had not been established so the procedure in the Pharmacology Laboratory of
Commercial Solvents Corporation was to provide results on one-page Bioassay forms.
Because these tests at 4 hours exposure demonstrate that AMP is not corrosive, it is not necessary to redo the studies
with the modern protocol that protocol is designed to refine the hazard of corrosive materials for the assignment of
packing groups.
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo study
- Type of information:
- experimental study
- Remarks:
- the tested substance is AMP one of the components of the compound
- Adequacy of study:
- weight of evidence
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards, and acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 5 daily applications of test material to the shaved abdomen of rabbits.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: supplier of animals not indicated, however all animals were sourced from a single supplier- Age at study initiation: All animals indicated to be 'young and healthy' nof urther information is given- Weight at study initiation: no data is given- Housing: Animals housed individually in cages - Diet (e.g. ad libitum): standard diet provided ad libitum throughout the study- Water (e.g. ad libitum): ad libitum water- Acclimation period: no details givem
- Type of coverage:
- open
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The paper indicates a 'measured' amount of test material was applied to the skin, however no further details are given
- Duration of treatment / exposure:
- The exposures were conducted daily for 5 days. The duration of the exposure was dependant upon the time until the test site appeared 'dry'. The test materials were not washed off after treatment
- Observation period:
- There is no data on the observation period. At a minimum it appears that the animals were observed for the full 5 days during treatment.
- Number of animals:
- number of animals used is not indicated in the report
- Details on study design:
- Animals were prepared by closely clipping the skin over the anterior abdominal wall. After securing the animal in the supine position, a measured amount of the test material was pipetted onto the surface of the skin. The test material was allowed to evaporate in still air, and the animal was released to the cage after the skin was dry. The treatments were repeated daily until 5 had been made.
- Irritation parameter:
- overall irritation score
- Remarks:
- No score available from study
- Time point:
- other: 5 days
- Reversibility:
- not specified
- Remarks on result:
- other: limited data available from literature source but sufficient to determine irritability. Confirmed by additional testing
- Irritant / corrosive response data:
- No illness resulted from skin applications of the test material, and observations were limited to irritation. Two animals showed chemical dermititis, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. There were no systemic effects noted and no significant bodyweight loss.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Even though the reporting of this work is limited, it is clear from the report that AMP is irritant under the described experimental conditions.
- Executive summary:
An undisclosed number of rabbits were shaved free of hair on the anterior abdominal wall. The rabbits were then secured in the supine position on an animal board and a measured amount of test material was pipetted onto the shaved area. No details of dose or approximate area of application are given. After test material administration the animals were left secured to the board in still air conditions until the test site was dry. No occlusive dressing was used and the test material was allowed to evaporate. Once the test site was dry each animal was returned to it's cage. This procedure was repeated daily for 5 days after which the animals were assessed for signs of illness and local effects at the test site. No illness resulted from the application of test compound to the skin and there were no signs of systemic toxicity or weight loss during the study. AMP caused a low grade chemical dermititis in two animals, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. Based on the results of this experiment, AMP is considered to be irritating to the skin.
Referenceopen allclose all
Results of Skin Irritation Study in Rabbits
Observation |
Endpoint |
Male 11499 |
Male 11887 |
Male 11901 |
Female 11580 |
Female 11658 |
Female 11802 |
1 hr |
Erythema |
4 X |
4 X |
4 X |
4 X |
4 X |
4 X |
1 hr |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
24 hrs |
Erythema |
4 X |
4 X |
4 X |
4 X |
4 X |
4 X |
24 hrs |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
48 hrs |
Erythema |
4 X |
4 X |
4 X |
4 X * |
4 X |
4 X * |
48 hrs |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
72 hrs |
Erythema |
4 * |
4 * |
4 X * |
4 X * |
4 * |
4 * |
72 hrs |
Edema |
2 |
2 |
2 |
2 |
2 |
2 |
6 days |
Erythema |
4 + |
4 * |
4 * |
4 * - |
4 + |
4 + - |
6 days |
Edema |
2 |
2 |
2 |
2 |
2 |
2 |
9 days |
Erythema |
W |
W |
W |
+ |
W |
+ |
9 days |
Edema |
C N |
C N |
N |
|
N |
W |
14 days |
Erythema |
N |
N |
N |
N |
N |
N |
14 days |
Edema |
N |
N |
N |
N |
N |
N |
X ¿ Necrosis in application area bordered by swelling
* - Application area hardened
+ - Wavy crust
- - Application area paper-like
W ¿ Bloody wounds
C - Crust formation
N ¿ Scar formation
Results of Skin Irritation Study
Day |
Animal |
|||||
1417 |
1491 |
1726 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
0 |
2 |
1 |
2 |
2 |
2 |
1 |
1 |
2 |
2 |
2 |
3 |
2 |
3 |
2 |
2 |
2 |
2 |
1 |
2 |
2B |
3 |
4 |
2A |
2 |
1C |
2 |
3B |
4 |
4 |
2A |
1 |
1C |
2 |
3B |
5 |
4 |
2A |
1 |
1C |
2 |
3B |
6 |
4 |
3A |
1 |
1C |
2 |
3B |
7 |
4 |
3A |
1 |
1C |
2 |
2B |
8 |
4A |
3C |
1 |
1C |
2 |
2B |
9 |
2 |
2 |
1 |
1C |
2B |
2B |
10 |
1 |
2 |
1 |
0 |
1 |
2 |
11 |
1 |
1 |
0 |
0 |
1 |
2 |
12 |
1 |
1 |
- |
- |
1 |
0 |
13 |
1 |
1 |
- |
- |
1 |
0 |
A - Necrosis B -Hyperkeratinization C - Desquamation
Only the corrosivity was determined, as such no information is provided on individual animal scores for erythema and edema. The conclusion of the assay was that the materials tested were not corrosive. No information is given on the irritancy of the material under the test circumstances.
Highly irritating
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- Conducted study is in vivo and was conducted prior to the requirement for in vitro studies and before these asays were perfected for use
- Type of information:
- experimental study
- Remarks:
- the tested substance is AMP one of the components of the compound
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study appears to have been conducted in accordance to a standard protocol (at the time) for assessing the eye irritation potential of compounds. Although there is limited information on the methods used the reporting is sufficient to come to a conclusion on the endpoint.
- Principles of method if other than guideline:
- Draize technique (Draize, J.H., Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. and Exp. Therapeutics. 82, 377–390.)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No details given
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml undiluted
- Duration of treatment / exposure:
- Animals were dosed with the test material, in one study the eyes were flushed 15-30 seconds after application, and in the other, they were not. No further methods information was given.
- Observation period (in vivo):
- scoring of results took place at 24 and 48 hours after exposure only. No further information on any subsequent observation period.
- Number of animals or in vitro replicates:
- 6 animals in each study
- Details on study design:
- No additional Information
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: un flushed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 69.3
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: eye flushed after 15 seconds
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 89.3
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: eye flushed after 30 seconds
- Irritant / corrosive response data:
- Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.
- Other effects:
- No details
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material is considered to be a severe eye irritant, and there is little beneficial effect even when eyes are almost immediately flushed with water.
- Executive summary:
In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeard to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- the tested substance is the sodium salt of DDBSA one of the components of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment, 47% formulation tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.1-3.1 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: March 24, 1986 To: May 12, 1986 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL aliquot of P-500 N-Na
- Duration of treatment / exposure:
- For three rabbits the eyelids were then gently held together for one second before releasing.
For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure.
For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure. - Observation period (in vivo):
- Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure.
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- Nine rabbits received a 0.1 mL aliquot of P-500 N-Na placed into the lower everted lid of one eye per animal. For three rabbits the eyelids were then gently held together for one second before releasing. For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure. For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure. Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure. Grading was performed using the standard scoring system.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinse after 4 seconds
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 1.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: rinsed after 30 seconds
- Irritant / corrosive response data:
- The following results were noted:
1) Three animals without any rinsing: averaged irritation scores (24, 48, 72 hours) for each animal: cornea 2.3, 1.7, 2; iris: 1.3, 0, 0; conjunctivae redness: 3, 1.7, 2; conjunctivae chemosis: 3, 2, 2. In the first animal the effects were persistent at day 14.
2) Three animals with rinsing for five minutes following a 30 second exposure: averaged scores: cornea 0.7, 1, 1.3; iris: 0, 0.7, 0.3; conjunctivae redness: 1.7, 2, 1.3; conjunctivae chemosis: 2, 1.3, 2. The eyes were normal 7 or 14 days after instillation.
3) Three animals with rinsing for five minutes following a 4 second exposure: averaged scores: cornea 0.7, 2.3, 0.7; iris: 0, 0, 0; conjunctivae redness: 1.7, 1.7, 1; conjunctivae chemosis: 1.3, 2, 1. The eyes were normal 7 days after instillation.
Findings lead to a definition of irritating for LAS at 47% applied without rinsing, irritating (even if with lower effects, mainly as cornea opacity and conjunctivae redness) with rinsing after 30 second of exposure, and not irritating with rinsing after 4 second of exposure.
Overall, instillation of P-500 N-Na into the eyes of rabbits elicited positive responses in all animals. Irrigation of the eyes only slightly reduced the irritation potential. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Result: irritating at 0.1 mL.
- Executive summary:
This study, performed according to OECD Guidelines, was conducted on three rabbits with LAS at 47%. Groups of three rabbits had 0.1 ml of test substance placed in each of their eyes. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 seconds of exposure. In the third group, the eyes were rinsed after 30 seconds of exposure. Observations were made one hour and 1, 2, 3, 4, 7, 14, and 21 days after exposure. Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. Mild irritation was seen in the animals rinsed after 4 seconds. These effects were fully reversible within 7 days. Since OECD guideline 405 for eye irritation studies calls for an exposure of at least 24 hrs, the results for unrinsed eyes were used for classification. According to these results, the test substance is a category 1 eye irritant because it caused damage that was not reversible within 21 days.
Referenceopen allclose all
Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.
Results of Eye Irritation Study,No Rinsing
|
|
Hours |
Days |
||||||
Animal |
|
1 |
24 |
48 |
72 |
4 |
7 |
14 |
21 |
1 |
Cornea |
2 |
1 |
2 |
4 |
3B |
3B |
3BC |
3BC |
Iris |
0 |
1 |
1 |
2 |
1 |
1 |
1 |
0 |
|
Conjunctiva - Erythema |
1 |
3 |
3 |
3 |
3 |
3 |
2 |
1 |
|
Conjunctiva,Chemosis |
2 |
3 |
3 |
3 |
3 |
2 |
2 |
1 |
|
2 |
Cornea |
1 |
1 |
2 |
2 |
2 |
1 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Conjunctiva - Erythema |
1 |
1 |
2 |
2 |
1 |
0 |
0 |
|
|
Conjunctiva ¿ Chemosis |
1 |
2 |
2 |
2 |
1 |
0 |
0 |
|
|
3 |
Cornea |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
|
Conjunctiva - Erythema |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
|
|
Conjunctiva,Chemosis |
1 |
2 |
2 |
2 |
2 |
0 |
0 |
|
Results of Eye Irritation Study,Rinsing after 4 Seconds
|
|
Hours |
Days |
||||
Animal |
|
1 |
24 |
48 |
72 |
4 |
7 |
1 |
Cornea |
0 |
0 |
1 |
1 |
1 |
0 |
Iris |
0 |
0 |
0 |
0 |
1 |
0 |
|
Conjunctiva - Erythema |
1 |
2 |
2 |
1 |
2 |
0 |
|
Conjunctiva,Chemosis |
2 |
2 |
1 |
1 |
1 |
0 |
|
2 |
Cornea |
0 |
2 |
3 |
2 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva - Erythema |
1 |
2 |
2 |
1 |
2 |
0 |
|
Conjunctiva,Chemosis |
2 |
2 |
2 |
1 |
1 |
0 |
|
3 |
Cornea |
0 |
1 |
0 |
1 |
1 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva - Erythema |
1 |
1 |
1 |
1 |
2 |
0 |
|
Conjunctiva,Chemosis |
2 |
1 |
1 |
1 |
1 |
0 |
Results of Eye Irritation Study,Rinsing after 30 Seconds
|
|
Hours |
Days |
|||||
Animal |
|
1 |
24 |
48 |
72 |
4 |
7 |
14 |
1 |
Cornea |
0 |
1 |
0 |
D |
D |
1 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva - Erythema |
1 |
2 |
2 |
1 |
1 |
1 |
0 |
|
Conjunctiva,Chemosis |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
|
2 |
Cornea |
0 |
1 |
1 |
1 |
2 |
0 |
|
Iris |
0 |
0 |
1 |
1 |
0 |
0 |
|
|
Conjunctiva - Erythema |
1 |
2 |
2 |
2 |
2 |
0 |
|
|
Conjunctiva,Chemosis |
2 |
1 |
2 |
1 |
1 |
0 |
|
|
3 |
Cornea |
0 |
1 |
2 |
1 |
2A |
2AB |
0 |
Iris |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
|
Conjunctiva - Erythema |
1 |
1 |
1 |
2 |
2 |
2 |
0 |
|
Conjunctiva,Chemosis |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
A Loss of Corneal Epithelium
B Vascularization
C Pannus
D Dulling of the Cornea
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Both components are (severely) irritant to the skin. A study on the sodium salt of DDBSA indicated that this substance is irritating to the skin. As during dermal exposure limited dissociation can be expected, it is concluded that the sodium salt data are more relevant than the data on the acid. Therefore the substance is considered non-corrosive and needs to be classified as irritating to the skin.
Justification for classification or non-classification
Based on the study results on DDBSA (sodium salt) and AMP, the compound is considered irritating to the skin and severely irritating to the eyes. According to CLP (Regulation EC No 1272/2008) the substance needs to be classified as H315 (category 2: causes skin irritation) and H318 (category 1: Causes serious eye damage)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.