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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 153202 0

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
according to guideline
Guideline:
other: US Food and Drug Administration (FDA) guideline
Deviations:
not applicable
GLP compliance:
not specified

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

Test animals

Species:
other: not stated in CICAD
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
No details on the amount of non-dissolved test substance applied is provided in the report.
Duration of treatment / exposure:
Not applicable; In CICAD no information is given on the duration of treatment
Observation period:
Not applicable; In CICAD no information is given on the observation period
Number of animals:
Not applicable; In CICAD no information is given on the number of animals treated

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not applicable
Score:
2
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: Study performed according to US FDA guideline
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not applicable
Score:
0
Max. score:
4
Remarks on result:
other: Study performed according to OECD 404.
Irritant / corrosive response data:
Not applicable
Other effects:
Not applicable

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information in one study and slightly irrtating in the other study Criteria used for interpretation of results: EU
Conclusions:
Application of non-dissolved 4-nitrophenol resulted in slight irritation of the skin in one investigation performed according to US FDA guideline, whereas a study according to OECD 404 showed no skin irritating effects for non-dissolved 4-nitrophenol.
Executive summary:

In the Concise International Chemical Assessment Document (CICAD), data on dermal irritation of 2- and 4-nitrophenol are reviewed. Application of non-dissolved 4-nitrophenol resulted in slight irritation of the skin in one investigation performed according to US FDA guideline, whereas a study according to OECD 404 showed no skin irritating effects for non-dissolved 4-nitrophenol.