4,4'-oxydiphthalic anhydride

Endpoint summary

Description of key information

In a test according to EU Method B.4, the test item was found to cause very slight erythema one hour after patch removal. The effects were fully reversible within 1 day.

In a test according to EU Method B.5, the test item was found to cause some eye irritation effects that were visible at the inspection 1h after administration. These effects were fully reversible after 1 day. During the observations at 24h and 48h, discharge was observed. All effects were fully reversible within 3 days.

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

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Vehicle:

other: acetone

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24h

Number of animals:

6

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Two animals showed very slight erythema (score of 1) one hour after patch removal.
The effects were however fully reversible within 1 day.

Although a longer exposure time than required by Annex V was employed, the UK c.a. considered the text to be acceptable.

Interpretation of results:

GHS criteria not met

Conclusions:

Not classifed.

Executive summary:

In a test according to EU Method B.4, the test item was found to cause very slight erythema one hour after patch removal. The effects were fully reversible within 1 day.

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

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Nature of substance: powder

Species:

rabbit

Strain:

New Zealand White

Amount / concentration applied:

100 mg

Number of animals or in vitro replicates:

6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

0.6

Reversibility:

fully reversible within: 72h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

0.6

Reversibility:

fully reversible within: 72h

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

0.5

Reversibility:

fully reversible within: 72h

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0.3

Reversibility:

fully reversible within: 72h

Irritant / corrosive response data:

The following observations were made after 1h in one or more animals:
- Conjunctival redness (score of 1 or 2)
- Chemosis (score of 1)
- Iris effects (score of 1)

The following observations were made after 24 and 48h in one or more animals:
- Discharge

All effects were fully reversible within 3 days.

In the second test, maximum scores of 1 were recorded for conjunctival redness and other eye effects.

Interpretation of results:

GHS criteria not met

Conclusions:

Not classifed.

Executive summary:

In a test according to EU Method B.5, the test item was found to cause some eye irritation effects that were visible at the inspection 1h after administration. These effects were fully reversible after 1 day. During the observations at 24h and 48h, discharge was observed. All effects were fully reversible within 3 days.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In a test according to EU Method B.4, the test item was found to cause very slight erythema one hour after patch removal. The effects were fully reversible within 1 day. Hence, classification for skin irritation is not required.

 

In a test according to EU Method B.5, the test item was found to cause some eye irritation effects that were visible at the inspection 1h after administration. These effects were fully reversible after 1 day. During the observations at 24h and 48h, discharge was observed. All effects were fully reversible within 3 days. Based on these findings, classification for eye effects is not required.