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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
Study period:
1987
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
EC Number:
427-090-8
EC Name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
Cas Number:
116044-44-1
IUPAC Name:
bis(ethyl (2R,3R)-3-(propan-2-yl)bicyclo[2.2.1]hept-5-ene-2-carboxylate)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction: 5% in propylene glycol (PG) and 5% in PG/FCA followed by undiluted epicutaneous application
Challenge: 1%, 10% and 100% in PG
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Induction: 5% in propylene glycol (PG) and 5% in PG/FCA followed by undiluted epicutaneous application
Challenge: 1%, 10% and 100% in PG
No. of animals per dose:
20 test animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100. No with. + reactions: 10.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10. No with. + reactions: 14.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1. No with. + reactions: 8.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100. No with. + reactions: 9.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10. No with. + reactions: 13.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10, 10, 1
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10, 10, 1. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100, 10, 1
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100, 10, 1. No with. + reactions: 4.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
other: moderate sensitiser