Registration Dossier
Registration Dossier
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EC number: 202-437-4 | CAS number: 95-64-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Authoritative data base
- Title:
- CAS No.: 95-64-7
- Author:
- Danish EPA Model
- Year:
- 2 012
- Bibliographic source:
- QSAR predictions by Danish Environmental Protection Agency (EPA)model powered by OASIS database; Commercial
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Estimation database
- Principles of method if other than guideline:
- Multicase model A33, data from GPMT or human experience (ACD Humans)
- GLP compliance:
- no
- Type of study:
- other: estimation
Test material
- Reference substance name:
- 3,4-xylidine
- EC Number:
- 202-437-4
- EC Name:
- 3,4-xylidine
- Cas Number:
- 95-64-7
- Molecular formula:
- C8H11N
- IUPAC Name:
- 3,4-dimethylaniline
Constituent 1
In vivo test system
Test animals
- Species:
- other: unspecified
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
Challenge
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: estimation
- Group:
- test chemical
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Skin sensitization: sensitising (Positive)
- Remarks on result:
- other: Reading: other: estimation. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: Skin sensitization: sensitising (Positive).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Skin sensitization: Sensitising (Positive) estimation values have been obtained for 3,4 xylidine. The estimation method used for the process is Multicase models.
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