Registration Dossier
Registration Dossier
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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- n.a. : study was provide by the ECHA with only limited information in answer to inquiry number 06-2120130700-73-0000.
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: particulate/powder
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- test group: 20
negative control group: 10 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: n.a. see remarks
- Remarks:
- study was provide by the ECHA with only limited information in answer to inquiry number 06-2120130700-73-0000
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Executive summary:
Study was provide by the ECHA with only limited information in answer to inquiry number 06-2120130700-73-0000.
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