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Toxicological information

Eye irritation

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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-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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye 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 / 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.