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Administrative data

Description of key information

Isophorone is not sensitizing in animals studies (Hüls AG, 1988).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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)
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.
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guinea pig maximization test (according to OECD Guideline 406, positive control not required by 1981 guideline version), sensitisation was not observed in any of 20 animals (Huels AG, 1988).

Justification for selection of skin sensitisation endpoint:
Only one valid study available. The study is a guideline study with acceptable restrictions: no positive control group (not required by 1981 version of guideline) with Klimisch score 2 (reliable with restrictions).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Assessment of isophorone concerning respiratory sensitisation is not possible because no data are available for this toxicological endpoint.

Justification for classification or non-classification

According to the criteria of CLP Regulation 1272/2008 isophorone is not classified as sensitizing to skin. Classification of isophorone concerning respiratory sensitisation is not possible because no data are available for this toxicological endpoint.