Registration Dossier
Registration Dossier
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EC number: 479-410-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard method equivalent to EC method, GLP-compliant, adequate experimental details for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24hours instead 4 hours; occlusive conditions instead of semi-occlusive
- Principles of method if other than guideline:
- 24h exposure dermal irritation test
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- up to 14 days
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Score:
- 1.8
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 7 d; Max. value at end of observation period: 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- 1.5
- Max. score:
- 2.2
- Remarks on result:
- other: Max. duration: 7 d; Max. value at end of observation period: 0
- Irritant / corrosive response data:
- Slight to moderate erythema amd oedema seen after 24h gradually
resolved over 96h and barely perceptible reactions persisted
at 7 days. By 14 days scores were zero. Reversibility of any observed effect: Changes fully reversible within 14 days
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study on the analogous substance, Renewable Diesel is expected to be slightly irritating to skin by on significant enough to warrant classification within the EU.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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