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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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
Not specified in report
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid GPMT conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-2,3-epoxypropane
EC Number:
203-439-8
EC Name:
1-chloro-2,3-epoxypropane
Cas Number:
106-89-8
Molecular formula:
C3H5ClO
IUPAC Name:
2-(chloromethyl)oxirane
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

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
9
Total no. in group:
15
Clinical observations:
No information available on severity of response observed
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Remarks on result:
other: no further information available
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: no detailed information available

Any other information on results incl. tables

9 of 15 guinea pigs showed a sensitizing effect

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
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.