Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

Constituent 1
Chemical structure
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)

Inductionopen allclose all
Route:
other: Intradermal injection
Vehicle:
other: Ethanol
Concentration / amount:
0.1-percent m-chloronitrobenzene with 0.1 ml Freunds’ adjuvant, diluted with ethanol.
Challengeopen allclose all
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

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.