Registration Dossier
Registration Dossier
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EC number: 701-280-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: No methods provided with report; not able to comment on GLP and or or OECD compliance
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrocarbons, C9-C11, cyclics, <2% aromatics
- EC Number:
- 925-894-8
- IUPAC Name:
- Hydrocarbons, C9-C11, cyclics, <2% aromatics
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- No methods description available
Test system
- Details on study design:
- No information on study design provided
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 1.3
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 3 (mild irritant)
- Remarks:
- R38 Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 2. The average edema score (24,48, and 72 hours) was 1.3. This finding warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. This finding warrants classification of the test material as a Category 3 mild dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
A primary dermal irritation study was conducted to evaluate the dermal irritation potential of a single dose of MRD-89 -519 in the rabbit.
Dermal application of MRD-89 -402 produced erythema and edema in all test animals. The average erythema score (24,48, and 72 hours) was 2. The average edema score (24,48, and 72 hours) was 1.3. Exfoliation was noted in two animals and desquamation in one animal, both at the day 7 observation.
This finding warrants classification of the test material as a skin irritant (R38) under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. This finding warrants classification of the test material as a Category 3 mild dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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