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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:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to guideline but was non-GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
Not specified in report
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplied by Eastman Kodak. Purity not specified.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intracutaneous and occlusive epicutaneous
Vehicle:
other: ethanol
Concentration / amount:
Induction: 1st 5%, 2nd 5%
Challenge: 1%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Induction: 1st 5%, 2nd 5%
Challenge: 1%
No. of animals per dose:
15
Details on study design:
A group of 15 guinea pigs were treated with a 5% solution of epichlorohydrin in acetone (w/v) for topical application and intradermal injection for the induction phase. Two weeks after the induction phase, they were subsequently challenged with 1% solution . The animals flanks were clipped and shaved with an electric razor. Challenge was not preceded by chemical depilation.
Challenge controls:
No data
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Concentration:
not applicable
No. of animals per dose:
not applicable
Details on study design:
not applicable
Statistics:
no data

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
9
Total no. in group:
15
Clinical observations:
No information available on severity of response observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 15.0. Clinical observations: No information available on severity of response observed.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not applicable

Any other information on results incl. tables

9 of 15 guinea pigs showed a sensitizing effect

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Epichlorohydrin caused skin sensitizaion in guinea pigs with 9 of 15 demonstrating a positive response..
Executive summary:

Epichlorohydrin was evaluated in the guinea pig maximization test. Sixty percent (9 of 15) of the guinea pigs showing a positive response.