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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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.
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
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
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..
Conclusions:
4,4'-Methylenedicyclohexanamine was a weak sensitiser on abraded skin of guinea pigs in a diluent of acetone/dioxane with 13% fat content, .
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

One of the components of this UVCB material is a skin sensitizer therefore it is reasonable to assume that this material may be able to cause sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Similar materials are not respiratory sensitzers.

Justification for classification or non-classification

Based on the data of similar materials and according to CLP Regulation (1272/2008), the test substance is classified as a skin sensitizer (Cat 1C).