4-nitrophenol

Eye irritation

Administrative data

Endpoint:

eye 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 153020 0

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 / tissue source

Species:

other: not stated in CICAD

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

in two of the studies and as 10% solution in the third study

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: The amount of 4-nitrophenol applied to the animals eye is not stated in CICAD
- Concentration (if solution): In the third study, a 10% solution of 4-nitrophenol was applied. The other two studies were performed with non-dissolved material.

Duration of treatment / exposure:

Not applicable; No information on the duration of treatment is given in CICAD.

Observation period (in vivo):

Not applicable; No information on the observation period is given in CICAD.

Number of animals or in vitro replicates:

Not applicable; No information on the number of animals tested is given in CICAD.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not applicable

Score:

1 - 2

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: study performed comparable to OECD 405

Irritant / corrosive response data:

Non-dissolved 4-nitrophenol was strongly irritating in a study performed according to FDA guideline, but was stated to be slightly irritating (score 1-2 of 4) in another investigation performed comparable to OECD 405.
4-nitrophenol applied as a 10% solution to the eyes was slightly irritating (FDA guideline).

Other effects:

Not applicable.

Any other information on results incl. tables

No other information.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information in two of the studies and strongly irritating in the third study. Criteria used for interpretation of results: EU

Conclusions:

4-nitrophenol is cited to be slightly irritating in two of the studies (applied as non-dissolved material and as a 10% solution) and strongly irritating to the eyes in a third study (performed with non-dissolved material).

Executive summary:

In the Concise Chemical Assessment Document on Mononitrophenols, toxicity data on 4 -nitrophenol are reviewed and summarized. Three studies on eye irritation are cited in the report showing slight irritation in two of the studies after application of a 10% solution or non-dissolved material and strong irritation in a third study where non-dissolved material was used.