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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritive database

Data source

Referenceopen allclose all

Reference Type:
other: Authoritative database
Title:
Skin sensitization study of test chemcial in guinea pig.
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
IFA GESTIS,2018
Reference Type:
other: Secondary source
Title:
IUCLID DATASET
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
IUCLID DATASET, EUROPEAN COMMISSION – European Chemicals Bureau, 18–FEB–2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of test chemical was performed in guinea pig by Buehler test
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Chloro-4-nitroaniline
- Molecular formula: C6H5CIN2O2
- Molecular weight: 172.57g /mole
- Substance type: organic
- Physical state: No data available
- Purity :No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
No sensitization reaction observed after challenge application,
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No sensitization reaction observed after challenge application.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
According to the guinea pig maximization method, the test chemical was considered to be not skin sensitizing.
Executive summary:

The skin sensitization study of test chemical was performed by Buehler test using OECD guideline 406 on guinea pig.No skin sensitization was observed after the challenge application.Hence,test chemical was considered as not skin sensitizing in guinea pig.