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Diss Factsheets

Administrative data

Description of key information

No reactions were observed in any of the cases so that m-chloro-nitrobenzene therefore it was evaluated as nonsensitising in the guinea pig under the study conditions.

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
The skin-sensitising potential of m-chloronitrobenzene was investigated in Dunkin-Hartley albino guinea pigs in the Magnusson and Kligman maximisation test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Age at study initiation: 7 to 8 weeks old
Route:
other: Intradermal injection
Vehicle:
other: Ethanol
Concentration / amount:
0.1-percent m-chloronitrobenzene with 0.1 ml Freunds’ adjuvant, diluted with ethanol.
Route:
other: Epidremal
Vehicle:
other: Ethanol
Concentration / amount:
0.1-percent m-chloronitrobenzene with 0.1 ml Freunds’ adjuvant, diluted with ethanol.
No. of animals per dose:
Group of 20 animals
Details on study design:


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period: One week
- Test groups: group of 20 animals
- Control group: Yes
- Site:No data available
- Frequency of applications: Once
- Duration: 1 week
- Concentrations: 0.1% with 0.1 ml Freunds’ adjuvant, diluted with ethanol.



B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period: 24 hrs
- Test groups:
- Control group:
- Site:
- Concentrations: 25-percent ethanol solution of the chemical
- Evaluation (hr after challenge):
Other:A second challenge was carried out in the same way after another 2 weeks.
Challenge controls:
Yes treated with ethanol alone.
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 and 25 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data available
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 and 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data available.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No reactions were observed in any of the cases so that m-chloro-nitrobenzene therefore it was evaluated as nonsensitising in the guinea pig under the study conditions.
Executive summary:

The skin-sensitising potential of m-chloronitrobenzene was investigated in Dunkin-Hartley albino guinea pigs (DUHA KFM strain, 7 to 8 weeks old) in the Magnusson and Kligman maximisation test. Groups of 20 animals were given intradermal injections of 0.1 ml Freunds’ adjuvant, diluted with etha-nol, and 0.1-percent m-chloronitrobenzene or just the adjuvant without test substance (control). One week thereafter, the animals which had been ex-posed to m-chloronitrobenzene were treated epidermally with a 25-percent ethanol solution of the chemical by affixing a soaked filter paper to the skin for 48 hours by means of a semi-occlusive dressing. The controls received ethanol alone. In order to assess the skin sensitising potential, a challenge treatment with 25-percent m-chloronitrobenzene or ethanol was carried out again after 2 weeks, but in this case the dressing was only left on for 24 hours. A second challenge was carried out in the same way after another 2 weeks. No reactions were observed in any of the cases so that m-chloro-nitrobenzene was evaluated as nonsensitising in the guinea pig.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin-sensitising potential of m-chloronitrobenzene was investigated in Dunkin-Hartley albino guinea pigs (DUHA KFM strain, 7 to 8 weeks old) in the Magnusson and Kligman maximisation test. Groups of 20 animals were given intradermal injections of 0.1 ml Freunds’ adjuvant, diluted with etha-nol, and 0.1-percent m-chloronitrobenzene or just the adjuvant without test substance (control). One week thereafter, the animals which had been ex-posed to m-chloronitrobenzene were treated epidermally with a 25-percent ethanol solution of the chemical by affixing a soaked filter paper to the skin for 48 hours by means of a semi-occlusive dressing. The controls received ethanol alone. In order to assess the skin sensitising potential, a challenge treatment with 25-percent m-chloronitrobenzene or ethanol was carried out again after 2 weeks, but in this case the dressing was only left on for 24 hours. A second challenge was carried out in the same way after another 2 weeks. No reactions were observed in any of the cases so that m-chloro-nitrobenzene was evaluated as nonsensitising in the guinea pig.

Justification for classification or non-classification