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Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Historical study
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.
Qualifier:
equivalent or similar to
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 available
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
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.
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
Statistics:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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..
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
4,4'-Methylenedicyclohexanamine was a weak sensitiser on abraded skin of guinea pigs in an exaggerated protocol using a diluent of acetone/dioxane with 13% fat content, .
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The evidence in the literature regarding the skin sensitisation caused by this substance is not particularly robust. The SIDS initial assesssment profile for C1 -C13 primary amines group (which includes 4,4'-methylenebis(cyclohexylamine)) is reporting no evidence of sensitization for the group members. DM-PACM a close structural analog to PACM is not a skin sensitizer. PACM appears to be a weak sensitiser in guinea pigs so the precautionary approach is adopted, and the material is considered a sensitiser. Personal protective equipment (gloves, eye protection) is recommended for use with this substance due to its corrosive properties, and should protect for potential sensitisation.


Migrated from Short description of key information:
4-4’-Methylenedicyclohexanamine is a weak sensitiser in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Weight of evidence suggests that the substance has weak sensitising properties.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In the absence of relevant data, PACM is not classified as a respiratory sensitiser.


Migrated from Short description of key information:
No data exists for respiratory sensitisation

Justification for classification or non-classification

Animal studies suggest that 4,4'-methylenedicyclohexanamine is a weak dermal sensitiser. In vivo studies are technically complicated due to the corrosive nature of the substance. Substances showing a low to moderate frequency of sensitisation effects in humans or low to moderate potency in animals can be presumed to produce sensitisation in humans, and are classified in Category 1B.

4,4'-Methylenedicyclohexanamine falls into this category.