1-chloro-3-nitrobenzene

Skin sensitisation

Administrative data

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

Data source

Reference

Reference Type:

secondary source

Title:

TOXICOLOGICAL EVALUATION

Author:

BG Chemie

Year:

2000

Bibliographic source:

BG Chemie InfoCenter TOXIKOLOGISCHE BEWERTUNGEN, last updated 11/2000

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-3-nitrobenzene

EC Number:

204-496-1

EC Name:

1-chloro-3-nitrobenzene

Cas Number:

121-73-3

Molecular formula:

C6H4ClNO2

IUPAC Name:

1-chloro-3-nitrobenzene

Details on test material:

- Name of test material (as cited in study report): 1-chloro-3-nitrobenzene
- Molecular formula (if other than submission substance): C6H4ClNO2
- Molecular weight (if other than submission substance): 157.556 g/mol
- Smiles notation: c1(cc(ccc1)Cl)[N+](=O)[O-]
- InChl : 1S/C6H4ClNO2/c7-5-2-1-3-6(4-5)8(9)10/h1-4H
- Substance type: Solid
- Physical state: Organic
- Impurities (identity and concentrations): No data

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: Intradermal injection

Vehicle:

other: Ethanol

Induction 2

Concentration / amount:

0.1-percent m-chloronitrobenzene with 0.1 ml Freunds’ adjuvant, diluted with ethanol.

Challenge

Challenge 1

Route:

other: Epidremal

Vehicle:

other: Ethanol

Challenge 2

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

Results and discussion

In vivo (non-LLNA)

Results

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.

Applicant's summary and conclusion

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.