4-nitrophenol

Skin irritation / corrosion

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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 guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not applicable

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: US Food and Drug Administration (FDA) guideline

Deviations:

not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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.