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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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Beta-Aminocrotonsäuremethylester, white solid, purity 99.5%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 12% (= 60 mg test substance/animal)
First and second challenge: 1% (= 5 mg test substance/animal)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: liquid paraffin
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 12% (= 60 mg test substance/animal)
First and second challenge: 1% (= 5 mg test substance/animal)
No. of animals per dose:
control group. 5
test substance group: 10
range-finding group: 2

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
Challenge 1%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: Challenge 1%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Group:
test group
Dose level:
Challenge 1%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. Group: test group. Dose level: Challenge 1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Group:
negative control
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: none.

Any other information on results incl. tables

Appearance and behaviour of the test substance group were not different from the control groups. At the end of the study, the body weight development of the treatment group animals corresponded to that of the control group animals.

The incidence of skin reactions (number of animals exhibiting skin effects) following the challenge is summarized in the following table:

               Test substance group (10 animals)              Control group (5 animals)
         Test substance patch     Control patch        Test substance patch     Control patch
 Hours  48 72  total   48  72  48  72  total  48  72
 1. Challenge 1%  3
 2. Challenge 1%  0

Applicant's summary and conclusion

Executive summary:

To determine the skin-sensitizing properties of methyl 3 -aminocrotonate the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:

intradermal induction: 5%

topical induction: 12%

first and second challenge: 1%

Under the condition of the maximization test and with respect to the evaluation criteria methyl 3 -aminocrotonate exhibited no skin-sensitization potential.