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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
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer-reviewed data collection from international group of experts.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
review article or handbook
Title:
Concise International Chemical Assessment Document 20; Mononitrophenols; 8.2 Irritation and sensitization
Author:
Fraunhofer Institute for Toxicology and Aerosol Research
Year:
2000
Bibliographic source:
International Programme on Chemical Safety (IPCS), ISBN 92 4 153020 0

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-nitrophenol
EC Number:
202-811-7
EC Name:
4-nitrophenol
Cas Number:
100-02-7
Molecular formula:
C6H5NO3
IUPAC Name:
4-nitrophenol
Details on test material:
- Name of test material (as cited in study report): 4-Nitrophenol

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: not applicable; summary of peer-reviewed data
Vehicle:
no data
Concentration / amount:
Not applicable; summary of peer-reviewed data
Challengeopen allclose all
Route:
other: not applicable; summary of peer-reviewed data
Vehicle:
no data
Concentration / amount:
Not applicable; summary of peer-reviewed data
No. of animals per dose:
Not applicable; summary of peer-reviewed data
Challenge controls:
Not applicable; summary of peer-reviewed data
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
Not applicable; summary of peer-reviewed data
No. of animals per dose:
Not applicable; summary of peer-reviewed data
Statistics:
Not applicable; summary of peer-reviewed data

Results and discussion

Positive control results:
Not applicable; summary of peer-reviewed data

In vivo (non-LLNA)

Results
Reading:
other: Not applicable; summary of peer-reviewed data
Group:
test chemical
Dose level:
Not applicable; summary of peer-reviewed data
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Not applicable; summary of peer-reviewed data
Remarks on result:
other: see Remark
Remarks:
Reading: other: Not applicable; summary of peer-reviewed data. Group: test group. Dose level: Not applicable; summary of peer-reviewed data. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Not applicable; summary of peer-reviewed data.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable; summary of peer-reviewed data
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable; summary of peer-reviewed data

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information
Conclusions:
In the IPCS CICAD Document it is cited that in a guinea-pig maximisation test comparable to OECD 406, skin sensitization was observed in 5 out of20 animals.
Executive summary:

In the IPCS CICAD Document it is cited that in a guinea-pig maximisation test comparable to OECD 406, skin sensitization was observed in 5 out of20 animals.