Registration Dossier
Registration Dossier
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EC number: 290-478-9 | CAS number: 90170-45-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-Alanine, N-coco acyl derivs., sodium salts
- EC Number:
- 290-478-9
- EC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Cas Number:
- 90170-45-9
- Molecular formula:
- RHNNaO3
- IUPAC Name:
- L-Alanine, N-coco acyl derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: Sodium Cocoyl-L-Alaninate (ACS-12)
Lot No.: 051020-2
Description: liquid
Purity: 30% (as active ingredient)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SUKA-FLAT, Japan
- Age at study initiation: no data
- Weight at study initiation: 3.9 – 4.2 kg
- Housing: individually in stainless-steel cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 26
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 7 days
- Number of animals:
- 3 m
- Details on study design:
- One the day before the treatment, hair on both flanks of each rabbit was clipped, using an animal hair trimmer and 3 animals with healthy intact skin were selected for the study. 0.5 mL of the test item was placed on a patch of 2.5*2.5 cm. The patch was applied to left side of clipped site of each animal, and covered semi-occlusive with a bandage tape. Four hours after application, the patch was removed and the application area was cleaned with absorbent cotton soaked with water for injection.
Clinical signs of all animals were observed once daily from delivery of the animals until termination of the study.
The skin irritation was assessed at approximately 1, 24, 48 and 72 hours after removal of the test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema was observed in all animals in 1-hour reading. Well defined erythema was observed 1 out of 3 animals in 24-hours reading. However, these changes recovered in 1 week reading. Scaling was observed 1 out of 3 animals in 1 week reading. Based upon the classification criteria, the test item was not irritating to the rabbit skin.
There were no mortality or abnormal clinical signs observed during the study period. The body weights of all animals were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test item was not irritating to the rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated in male NZW rabbits. The test item was applied with a semiocclusive patch to rabbit skin for 4 hours, and the application site was observed periodically. It was concluded that the test item is not irritating to the rabbit skin.
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