Registration Dossier

Administrative data

Description of key information

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:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to guideline but was non-GLP.
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
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.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Route:
other: intracutaneous and occlusive epicutaneous
Vehicle:
other: ethanol
Concentration / amount:
Induction: 1st 5%, 2nd 5%
Challenge: 1%
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
Positive control results:
no data
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
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

9 of 15 guinea pigs showed a sensitizing effect

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

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


Migrated from Short description of key information:
Epichlorohydrin was evaluated in the guinea pig maximization test. Sixty percent (9 of 15) of the guinea pigs showing a positive response.

Justification for classification or non-classification

Epichlorohydrin was positive in the guinea pig maximization test with sixty percent (9 of 15) of the guinea pigs showing a positive response. Thus, epichlorohydrin is classified for dermal sensitization.