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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The original study is available in Japanese only. The following evaluation is based on an English translation (Harlan Japan) of the report. The study was carried out according to the skin sensitisation test method B.6 suggested by the European Commission with acceptable restrictions.

Data source

Reference
Reference Type:
publication
Title:
Sensitization test of chloroform: Comparison of guinea pig maximization test (GPMT) and local lymph node assay (LLNA)
Author:
Matsuoka C, Kanazawa Y, Kojima K
Year:
2002
Bibliographic source:
Annual Report of Hatano Research Institute

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
chloroform was obtained from Wako Pure Chemicals Industry, Ltd.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
five weeks old female guinea pigs; temperature between 21 and 25 °C, humidity between 40 and 75 %, air exchange rate 15 times/hour, 12hr light/12 hr darkness

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
no data
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
no data
No. of animals per dose:
5 animals for sensitisation test with chloroform, 3 animals for controls
Details on study design:
Day 1: intradermal administration of chloroform and Freund's complete adjuvant as primary sensitisation (five test animals)
Day 8: open application of 10 % sodium lauryl sulfate as secondary sensitisation (five test animals)
Day 9: 48 hours application of occlusive patch as patch sensitisation (five test animals)
Day 22: 24 hours application of occlusive patch as challenge (five test animals, three control animals)
Challenge controls:
challenge controls with 24 hours application of occlusive patch on Day 22 with three control animals
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
no data
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: no data. No with. + reactions: 5.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
no data
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: no data. No with. + reactions: 5.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Significant suppression of body weight gain compared to the control group was seen at secondary sensitisation (Day 9) after intradermal chloroform administration (Day 1). Extensive necrosis at the chloroform administration site was observed from the day after administration, and piloerection and decreased spontaneous movement were observed for one week following intradermal administration. In the evaluations at 48 and 72 hours after the start of the challenge, erythema (score 1 or 2, slight to mild) was observed in all eight animals including the three control group animals. This reaction at the challenge site was observed until 8 days after the start of challenge, with a tendency for the erythema to become stronger over time in all 8 animals including the control group, confirming that chloroform is a strong irritant.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Sensitisation could not be definitely evaluated due to the strong irritation reaction, but since skin reactions were comparable in the chloroform sensitisation group and the control group, chloroform sensitisation was judged to be negative in GPMT.
Executive summary:

The skin sensitisation potential of chloroform was tested in the guinea pig maximisation test according to test method B.6 suggested by the European Commission. Sensitisation was tested with 5 female Hartley guinea pigs in the sensitisation group and 3 female animals in the control group.

Significant suppression of body weight gain compared to the control group was seen at secondary sensitisation (Day 9) after intradermal chloroform administration (Day 1). Extensive necrosis at the chloroform administration site was observed from the day after administration, and piloerection and decreased spontaneous movement were observed for one week following intradermal administration. In the evaluations at 48 and 72 hours after the start of the challenge, erythema (score 1 or 2, slight to mild) was observed in all eight animals including the control group. This reaction at the challenge site was observed until 8 days after the start of challenge, with a tendency for the erythema to become stronger over time in all 8 animals including the control group, confirming that chloroform is a strong irritant.

Sensitisation could not be definitely evaluated due to the strong irritation reaction, but since skin reactions were comparable in the chloroform sensitisation group and the control group, chloroform sensitisation was judged to be negative in GPMT.