Registration Dossier
Registration Dossier
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EC number: 211-014-3 | CAS number: 627-83-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jun 1991 - 15 Jun 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA (Federal Hazardous Substances Control Act), 16 CFR 1500.41
- Deviations:
- yes
- Remarks:
- 25 instead of 24 h exposure.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethylene distearate
- EC Number:
- 211-014-3
- EC Name:
- Ethylene distearate
- Cas Number:
- 627-83-8
- Molecular formula:
- C38H74O4
- IUPAC Name:
- 2-(octadecanoyloxy)ethyl octadecanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: pelleted, Purina Rabbit Chow , ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- concentration: undiluted and not moistened
- Duration of treatment / exposure:
- 25 h
- Observation period:
- 72 h
Reading time points: 25 and 72 h - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm² (see study report)
- Type of wrap if used: adhesive-backed gauze patches secured in place with an elastic wrapping.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped clean of any residual test material
- Time after start of exposure: 25 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: See remarks
- Remarks:
- Since no effects were observed at the 25- and 72-h reading time point, the 48 h values were assumed to be the same as those at 25 h (worst case assumption: persistence of effects seen at 25 h over 48 h). Overall, it can be concluded that these data represent a mean score (24/48/72 h).
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: See remarks
- Remarks:
- Since no effects were observed at the 25- and 72-h reading time point, the 48 h values were assumed to be the same as those at 25 h (worst case assumption: persistence of effects seen at 25 h over 48 h). Overall, it can be concluded that these data represent a mean score (24/48/72 h).
- Irritant / corrosive response data:
- Intact skin:
No erythema or edema was observed in any animal during the study period.
Abraded skin:
After 25 h slight erythema formation was observed in 2/6 animals being fully reversible within 72 h.
No edema formation was observed in any animal during the study period. - Other effects:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
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