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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:
1988-05-19 - 1988-08-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions: no positive control group (not required by 1981 version of guideline)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A skin sensitization test according to OECD 406 has already excisted since 1988 and is sufficient for evaluation of the skin sensitisation potential of the test substance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: as prescribed by 1.1 - 1.4

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino, Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Albino, Bor: DHPW
- Sex: female
- Source: F. Winkelmann, Borchen (DE)
- Weight at study initiation: 314.2 g (mean)
- Controls: 10 animals

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Challenge undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Challenge undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous
No. of animals per dose:
20 females (test) / 10 females (control)
Details on study design:
ADMINISTRATION/EXPOSURE 
- Concentration in Freuds Complete Adjuvant (FCA): 10 %
- Positive control: no
Challenge controls:
similarly treatmant, but with vehicle alone
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 % test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no treatment related effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 % test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no treatment related effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 % test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no treatment related effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 % test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no treatment related effects.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a guinea pig maximization test (according to OECD Guideline 406, positive control not required by 1981 guideline version), sensitization was not
observed in any of 20 female animals.
Executive summary:

The skin sensitizing properties of isophorone were conducted in a guinea pig maximation test according to OECD 406 (positive controls not required by 1981 guideline version). Twenty female guinea pigs were intradermally injected with a 10 % concentration of isophorone (in corn oil) and one week later epidermally exposed to a 100 % concentration of test substance. Ten control animals were similary treated, but with vehicle alone. Two weeks after the epidermal application all animals were challegend with 100 % test substance and the vehicle.

Under the conditions of the test no sensitizing effects were observed in any of the 20 animals at all. Based on these results, isophorone should not be classified as contact sensitizer.