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EC number: 938-774-5 | CAS number: 85408-49-7
- 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 skin or eye irritation studies are available for C12-16 amine oxide. Data are read across from C12-14 and C12-18 AO on the basis of the large overlap in chain length distributions between the substances. On this basis, C12-16 amine oxide is 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: no data
- Weight at study initiation: 2.6-3.4 kg
- Housing:no data
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/- 10
- Air changes (per hr): air conditioned room, no data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 % w/v - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage:
- Type of wrap if used: semi-occlusive binding, no further details
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no description of method
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 & 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 & 72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The C12-18 AO is a skin irritant in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1978-09-12 To 1978-10-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: As per OECD guideline 405. Non-GLP
- 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: 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
- Remarks:
- Migrated information
- 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.
Reference
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 (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No skin or eye irritation studies are available for C12-16 amine oxide. Data are read across from C12-14 and C12-18 AO on the basis of the large overlap in chain length distributions between the substances.
Skin irritation
In the key study, performed according to OECD TG 404 using C12-18 AO [Hollander & Rupprich (1978) ], the test material (0.5 mL, 30 %AO) was applied to the intact skin of 3 female rabbits (New Zealand White) and covered with a semi-occlusive dressing for 4 hours. At the end of the exposure period the treatment sites were cleaned and reactions noted over a 14 day period. Well-defined to severe erythema was observed in all three test animals at 24 and 48 hours. At 72 hours barely perceptible to well-defined erythema was observed. These reactions had completely cleared by 14 days. Barely perceptible oedema was observed in two animals up to 48 hours and was completely cleared by 7 days.
In a study, performed according to OECD TG 404 [Fulfs JC (1978b) ], 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 (1978b) ].
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 [Haynes G (1982a,b); Sugar JR & Haynes G (1981)].
Three further studies are available performed using lower concentrations of C12-14 AO. In the first of these [Nicholas P & Jones JR (1976a) ] 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 [Heisler E et al (1975)]. In the third study [Kukulinski M (1997a) ] 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
In the key study for this endpoint, performed according to OECD TG 405 [Fulfs JC (1978c) ] 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 C12-14 AO caused irreversible damage to the rabbit eye.
In a supporting study performed according to OECD TG 405 [Dean WP (1978c)] 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 C12-14 AO 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 C12-14 AO. In both of these studies, which used 6 % AO [Nicholas P & Jones JR (1976b) ] and 5 % or 2.5 % AO [Kukulinski M (1997b) ] 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.
Only one study is available for C12-18 AO, the reliability of which cannot be properly assessed. In this study [Bullens P (1984b) ] C12-18 AO (0.1 mL, 5 % AO) was instilled into the right eye of 6 rabbits. The untreated left eye served as a control for each rabbit. Both the treated and untreated eyes were examined at 24, 48 and 72 hours. Based on the effects seen, the solution containing 5 % AO was an eye irritant in this study.
Justification for selection of skin irritation / corrosion endpoint:
The Hollander & Rupprich (1983) study was performed to OECD TG 404 under GLP and has a Klimisch score of 1. The chain length distribution of the substance tested (C12-18 AO) covers C12-16 AO.
Justification for selection of eye irritation endpoint:
Study performed to OECD TG 405 and has a Klimisch score of 2.
Effects on skin irritation/corrosion: highly irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
No skin or eye irritation studies are available for C12-16 amine oxide. Data are read across from C12-14 and C12-18 AO on the basis of the large overlap in chain length distributions between the substances and used to determine the classification and labelling of C12-16 amine oxide.
The substance is classified as Skin Irritant Category 2 on the basis of the reactions seen in the skin irritation studies performed with both C12-14 and C12-18 AO.
C12 -14 AO caused damage to the eyes of rabbits that did not fully reverse during the 21 day observation period and is therefore classified as Eye Damage Category 1. This classification is read across to C12 -16 AO.
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