Registration Dossier
Registration Dossier
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EC number: 293-036-3 | CAS number: 91050-89-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions. Limited documentation but relevant data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted 24 April 2002
- Deviations:
- yes
- Remarks:
- limited documentation, limited information on test substance given, 2 h exposure only
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C8-10, triesters with trimethylolpropane
- EC Number:
- 293-036-3
- EC Name:
- Fatty acids, C8-10, triesters with trimethylolpropane
- Cas Number:
- 91050-89-4
- Molecular formula:
- Not available.
- IUPAC Name:
- tri-esters of octanoic acid and decanoic acid with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
- Details on test material:
- - Name of test material (as cited in study report): [trade name], Trimethylolpropan-C8/10-ester
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 3.7 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 100% - Duration of treatment / exposure:
- 2 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 5 males
- Details on study design:
- TEST SITE
- Area of exposure: 9 cm²
- Type of wrap if used: the treated skin was covered with occlusive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with water
- Time after start of exposure: 2 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 5 animals
- Time point:
- 24/48/72 h
- Score:
- 0.24
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 5 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- At tape removal and after 1 h, no effects on the skin were observed. After 24 h, 3 animals showed erythema, which persisted in 1 animal for 48 h. 72 h after exposure, all animals were free of erythema.
Edema were not observed at all.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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