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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data taken from a review of nitro-phenol.
4-Nitrophenol considered suitable for read-across potential for toxicity the oxidation form of the nitrogen is not critical for short term toxic effects.
The class of substance is considered to be a potential skin sensitiser

Data source

Reference
Reference Type:
review article or handbook
Title:
Concise International Chemical Assessment Document 20
Author:
World Health Organisation
Year:
2000
Bibliographic source:
International Programme on Chemical Safety, Concise International Chemical Assessment Document 20

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buehler, non-maximised method
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Historical study. Results proved positive so no further testing is justified.

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
Test material form:
solid: crystalline
Specific details on test material used for the study:
Not specified
4-Nitrophenol considered suitable for read-across potential for toxicity the oxidation form of the nitrogen is not critical for short term toxic effects.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified in the review

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Not specified in the review
Adequacy of induction:
other: Not specified in the review
Challenge
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Not specified in the review
Adequacy of challenge:
other: Not specified in the review
No. of animals per dose:
20
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Not specified in the review
Group:
test chemical
Dose level:
Not specified in the review
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Not specified in the review
Remarks on result:
other: Details not provided, but considered positive

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Although very little detail is provided in in the review, the fact that 5/20 positivbe results were observed in a non-maximised study suggests some potential for skin sensitisation.
A classification as Skin Sens 1 is given and no further work is considered to be necessary