Acetamide, N-(4-fluorophenyl)-2-hydroxy-N-(1-methylethyl)-

Endpoint summary

Description of key information

The irritant/corrosive potential of the test substance was studied on the skin and eye of the rabbit in accordance with the OECD Guidelines Nos. 404 and 405 for Testing of Chemicals.

Skin irritation in vivo (rabbit):

The results of the exposure of the test substance to the skin did not show any signs of irritation in the animals. Toxic signs were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as not irritating to the skin.

 

Eye irritation in vivo (rabbit):

Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea and discharge in all animals. The iris was also transiently affected in one animal. These signs proved to be fully reversible within 7 days. Non-ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as moderately irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14. - 21. January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Purity: 99.2 %;
stability in water not tested
(pulverized compound and patch moistened with water)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

not irritating to the skin (exposure period: 4 hrs)

Executive summary:

The irritant/corrosive potential of the test substance was studied on the skin and eye of the rabbit in accordance with the OECD Guidelines Nos. 404 and 405 for Testing of Chemicals. Whilst considering OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the responses observed. The results of the exposure of the test substance to the skin did not show any signs of irritation in the animals. Toxic signs were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14.- 21. January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Purity: 99.2 %
Identity/Stability: guaranteed for the study period

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µl, equivalent to app. 61 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.88

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Moderately irritating to the eye (exposure period: 24 hrs).
Reactions of the mucous membranes and effects of the cornea and discharge were evident in all animals. The iris was also transiently affected in one animal. These signs proved to be fully reversible within 7 days. Non-ocular lesions and other signs of toxicity were not observed.

Executive summary:

The irritant/corrosive potential of the test substance was studied on the skin and eye of the rabbit in accordance with the OECD Guidelines Nos. 404 and 405 for Testing of Chemicals. Whilst considering OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the responses observed.

Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea and discharge in all animals. The iris was also transiently affected in one animal. These signs proved to be fully reversible within 7 days. Non-ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as moderately irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study results for skin irritation no classification and for eye irritation allocation to category 2 (H319) according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.