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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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