Registration Dossier
Registration Dossier
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EC number: 229-962-1 | CAS number: 6864-37-5
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization capacity of epoxy resin hardeners in the guinea pig.
- Author:
- Thorgeirsson A.
- Year:
- 1 978
- Bibliographic source:
- Acta Derm. 58: 332-336
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- pre-GLP study according to original description of the GPMT; no positive control used, however, several simultaneously tested compounds were positive thus providing the sensitivityof the test system.
- Principles of method if other than guideline:
- Magnusson & Kligman: The identification of contact allergens by animal assay. The guinea pig maximization test. J Invest Dermatol 52: 268, 1969.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted well before LLNA guideline was available.
Test material
- Reference substance name:
- 2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 229-962-1
- EC Name:
- 2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 6864-37-5
- Molecular formula:
- C15H30N2
- IUPAC Name:
- 4-[(4-amino-3-methylcyclohexyl)methyl]-2-methylcyclohexan-1-amine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction: 0.5 % intracutaneous
Induction: 0.5 % occlusive epicutaneous
Challenge: 2 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction: 0.5 % intracutaneous
Induction: 0.5 % occlusive epicutaneous
Challenge: 2 % occlusive epicutaneous
- No. of animals per dose:
- 15
- Details on study design:
- Induction:
The test animals were given subcutaneous and topical applications of the test substance in acetone and/or Freund's Complete Adjuvant at a final concentration of 0.5%. Control animals received the corresponding vehicle.
Challenge:
At two weeks after the last induction, animals of both the test and control group received a topical application of the test substance in acetone at a final concentration of 2% (24-hour occluded patch). The skin was scored at 24 hours after removal of the test patch.
Criteria for selection of induction concentration was systemic toxicity reported in the literature. Criteria for selection during induction is not given. No criteria for selection of challenge concentration was given. Number of animals reacting during induction is not given. - Positive control substance(s):
- yes
- Remarks:
- CFA
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
No skin reactions were observed after challenge in both test (0/15) and control animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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