Registration Dossier
Registration Dossier
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EC number: 603-894-6 | CAS number: 135108-88-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to guideline study, non-GLP, but using a high-lipid diluent to maximize percutaneous absorption.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- high-lipid diluent to maximize percutaneous absorption
- Principles of method if other than guideline:
- similar to a Buehler protocol
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Historical study
Test material
- Reference substance name:
- 4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 217-168-8
- EC Name:
- 4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 1761-71-3
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 4,4'-methylenedicyclohexanamine
- Details on test material:
- 4,4'-Methylenedicyclohexanamine > 95% purity. Is a liquid with freezing/melting point of 13 degrees C.
Isomer composition %:
trans-trans 21.22%
cis-cis 14.91%
cis-trans 59.67%
Impurity: 2,4'-Methylenedicyclohexanamine: 4.20%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: dermal application to abraded skin
- Vehicle:
- other: acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- Concentration / amount:
- Induction: no data. Challenge: 2% in acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
Challengeopen allclose all
- Route:
- other: dermal application to intact and abraded skin
- Vehicle:
- other: acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- Concentration / amount:
- Induction: no data. Challenge: 2% in acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- No. of animals per dose:
- 5 guinea pigs challenged with intact skin, 5 guinea pigs challenged with abraded skin
- Details on study design:
- The test material, as a solution in acetone/dioxane (1:1 v/v) with 13% guinea pig fat, was applied to the abraded skin of 10 guinea pigs 9 times over 3 weeks. After a 2 week rest period, the material was reapplied at a level of 2% in the same diluent to intact and abraded skin, as a challenge dose. Sensitization of the animals was then assessed qualitatively.
- Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2% on challenge
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- assume reading was 24 h after challenge.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2% on challenge. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: assume reading was 24 h after challenge..
Applicant's summary and conclusion
- Conclusions:
- 4,4'-Methylenedicyclohexanamine was a weak sensitiser on abraded skin of guinea pigs in a diluent of acetone/dioxane with 13% fat content, .
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