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Toxicological information

Skin sensitisation

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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:
1978
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

Constituent 1
Chemical structure
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'-methylenebis(2-methylcyclohexanamine)

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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