Registration Dossier
Registration Dossier
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EC number: 260-701-4 | CAS number: 57365-08-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea Pig Maximization Test
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- old study
Test material
- Reference substance name:
- 2-amino-N-cyclohexyl-N-methylbenzylamine
- EC Number:
- 260-701-4
- EC Name:
- 2-amino-N-cyclohexyl-N-methylbenzylamine
- Cas Number:
- 57365-08-9
- Molecular formula:
- C14H22N2
- IUPAC Name:
- 2-amino-N-cyclohexyl-N-methylbenzylamine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% test substance in 0,1 ml
- Day(s)/duration:
- 1. day
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 15 % test substace in 1 ml
- Day(s)/duration:
- 8. day / 48h
Challenge
- No.:
- #19
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10% test substance in 0,5 ml
- Day(s)/duration:
- 22. day / 24 h
- No. of animals per dose:
- 20 animals negativ control
20 animals test substance - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% in 0,5ml
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in 0.5ml
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: 2 animals show skin irritation on skin which was not treated with the test substance. 1 animal shows skin irritation on the side which was treaded with test substance.
Any other information on results incl. tables
2 animals died because of pneumonia
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-Amino-N-cyclohexyl-N-methylbenzylamine is not sensitizing
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