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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
The study was conducted according to generally valid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guideline methods. Study was summarized in documents published from OECD SIDS program. However, original company divested this business to another company and neither has a copy of the original report.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed prior to the implementation of the LLNA method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Butanone oxime
EC Number:
202-496-6
EC Name:
Butanone oxime
Cas Number:
96-29-7
Molecular formula:
C4H9NO
IUPAC Name:
butan-2-one oxime
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
4% intracutaneous
100% epicutaneous (occlusive)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50%
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: specifics not reported
Group:
test chemical
Dose level:
4% intracutaenous induction, 100% epicutaneous induction, 50% epicutaneous challenge
No. with + reactions:
7
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
other: Category 1B based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
Conclusions:
Under the conditions of this study, MEKO induced a sensitization rate of 70% in the guinea pig.