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EC number: 939-607-9 | CAS number: 1474044-65-9
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- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
In an OECD guideline skin irritation test in rabbits, C12-14 ADMAES was corrosive. C12-14 ADMAES is also expected to be corrosive to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 404 and EU Method B.4 in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage cunicole da Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.6 +/- 0.2 kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 3 minutes or 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with compress soaked in water
- Time after start of exposure: 3 minutes or 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: exposure period: 3 minutes
- Irritation parameter:
- edema score
- Basis:
- other: range of scores
- Time point:
- other: 24, 48 and 72 h
- Score:
- >= 2 - <= 2.7
- Max. score:
- 2.7
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: exposure period: 3 minutes
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: exposure period: 4 hours
- Irritation parameter:
- edema score
- Basis:
- other: range of scores
- Time point:
- other: 24, 48 and 72 h
- Score:
- >= 2.7 - <= 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: exposure period: 4 hours
- Irritant / corrosive response data:
- Exposure period: 3 minutes
- severe erythema was noted at the treated skin site at 24, 48 and 72 h
- slight edema was noted at the treated skin site at 24, 48 and 72 h
Exposure period: 4 h
- severe erythema was noted at the treated skin site at 24, 48 and 72 h
- slight to severe edema was noted at the treated skin site at 24, 48 and 72 h - Interpretation of results:
- Category 1C (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the erythema and edema scores of the test substance was calculated to be 4.0 and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4 h exposure), respectively.
- Executive summary:
A OECD guideline study was performed to assess the skin irritation potential of C12-14 ADMAES in New Zealand White rabbits. The test substance (500 mg) was applied to the shaved skin area on the back of each animal under semi-occlusive dressing. A single 3-minute or 4-hour application of the test substance to the intact skin of three rabbits produced severe erythema and oedema. Under the test conditions, the mean erythema and oedema scores were 4.0 (3-minute and 4-hour exposure), and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4-hour exposure), respectively. Effects were not fully reversible within the 14 day observation period. The test substance was considered corrosive to the skin of rabbits.
Reference
Table 1: Individual skin reactions following 3 minutes exposure
Rabbit number | Skin reaction | Scores |
Mean irritation score | Scores |
|||||||||||||
1h / Day 1 | 24h / Day 2 | 48 h / Day 3 | 72h / Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 15 | |||
# 1 | Erythema | 3 | 4 | 4 | 4 | 4.0 | 4 | LN | LN | LN | LN | LN | LN | DT | DT | LA | LA |
Edema | 0 | 2 | 2 | 2 | 2.0 | 2 | LN | LN | LN | LN | LN | LN | DT | DT | LA | LA | |
Other | * | N | N | N | N/A | N | N | N | N | N | N | A | A | A/S | A/S | ||
# 2 | Erythema | 2 | 4 | 4 | 4 | 4.0 | 4 | 4 | 4 | 4 | LN | LN | LN | LN | LA | LA | LA |
Edema | 0 | 2 | 2 | 2 | 2.0 | 2 | 0 | 0 | 0 | LN | LN | LN | LN | LA | LA | LA | |
Other | * | * | * | * | N | N | N | N | N | N | N | N | A/S | A/S | A/S | ||
# 3 | Erythema | 2 | 4 | 4 | 4 | 4.0 | 4 | 4 | 4 | 4 | LN | LN | LN | LN | LA | LA | LA |
Edema | 0 | 4 | 2 | 2 | 2.7 | 2 | 0 | 0 | 0 | LN | LN | LN | LN | LA | LA | LA | |
Other | * | * | * | N | N | N | N | N | N | N | N | N | A | A | A |
* no reaction
N = necrosis
S = dry skin
A = crust
DT = tissue destruction
LN = reading masked by necrosis
LA = reading masked by crust
Table 2: Individual skin reactions following 4 hours exposure
Rabbit number | Skin reaction | Scores |
Mean irritation score | Scores |
|||||||||||||
1h /Day 1 | 24h /Day 2 | 48 h / Day 3 | 72h / Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 15 | |||
# 1 | Erythema | 4 | 4 | 4 | 4 | 4.0 | 4 | LN | LN | LN | LN | LN | LN | LN | LN | DT | DT |
Edema | 4 | 4 | 4 | 4 | 4.0 | 4 | LN | LN | LN | LN | LN | LN | LN | LN | DT | DT | |
Other | N | N | N | N | N | N | N | N | N | N | N | N | N | A/S | A/S | ||
# 2 | Erythema | 4 | 4 | 4 | 4 | 4.0 | LN | LN | LN | LN | LN | LN | LN | LN | LA | LA | LA |
Edema | 4 | 4 | 2 | 2 | 2.7 | LN | LN | LN | LN | LN | LN | LN | LN | LA | LA | LA | |
Other | N | N | N | N | N | N | N | N | N | N | N | N | A/S | A/S | A/S | ||
# 3 | Erythema | 4 | 4 | 4 | 4 | 4.0 | 4 | 4 | 4 | 4 | LN | LN | LN | LN | LA | LA | LA |
Edema | 4 | 4 | 3 | 2 | 3.0 | 4 | 0 | 0 | 0 | LN | LN | LN | LN | LA | LA | LA | |
Other | N | N | N | N | N | N | N | N | N | N | N | N | A/S | A/S | A/S |
* no reaction
N = necrosis
S = dry skin
A = crust
DT = tissue destruction
LN = reading masked by necrosis
LA = reading masked by crust
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A OECD guideline study was performed to assess the skin irritation potential of C12-14 ADMAES in New Zealand White rabbits. The test substance (500 mg) was applied to the shaved skin area on the back of each animal under semi-occlusive dressing. A single 3-minute or 4-hour application of the test substance to the intact skin of three rabbits produced severe erythema and oedema. Under the test conditions, the mean erythema and oedema scores were 4.0 (3-minute and 4-hour exposure), and ranged from 2.0 to 2.7 (3-minute exposure) and 2.7 to 4.0 (4-hour exposure), respectively. Effects were not fully reversible within the 14 day observation period. The test substance was considered corrosive to the skin of rabbits (Molinier, 1995).
Justification for selection of skin irritation / corrosion endpoint:
One reliable study conducted according to OECD guidelines.
Justification for selection of eye irritation endpoint:
Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation: the available information regarding skin irritation indicates the substance to be corrosive.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Skin
In a guideline in vivo skin irritation studyC12-14 ADMAES wascorrosive to skin following a 4-hour semi-occlusive exposure. No effects were observed following a exposure for 3 minutes. Based on these data the following classification is proposed: C; R34 (causes burns) according to Directive 67/548/EEC andskin corrosive category 1C; H314 - causes severe skin burns and eye damage according to Regulation EC 1272/2008.
Eye
Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation as the available information regarding skin irritation indicates the substance to be corrosive.
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