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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation was not observed in the reliable in vivo studies in the rabbit.  The irritation responses were not sufficient for classification under EU CLP Regulation (EC) No. 1272/2008.
No eye irriration was observed in a reliable in vivo study in the rabbit.  The irritation responses were not sufficient for classification under EU CLP Regulation (EC) No. 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION

Test Guidance

Skin irritation study performed according to method of Federal Hazardous Substances Act (16 CFR 1500).

 

Method and Material

Six New Zealand White rabbits were shaved and a 0.5 mL portion of the test material was applied to an intact or abraded skin site. The test article was then covered with 2.5x2.5 cm2surgical gauge pad and a Kendal Webril pad. The latter was held in place with 3 inch hypo-allergenic cloth tape. After both test sites were treated, the entire trunk of each animal was encased in an impermeable plastic occlusive wrapping fixed in place with 3 inch porous tape. This aided in maintaining the test article and patches in position and prevented the evaporation of possible volatile components of the test article. 

The wrapping was removed after 24 hours and washed from the skin with water and paper towels. Treated areas were examined for erythema and oedema using the Draize method of scoring at 24 and 72 hours.

Results

The neat (100%) test material induced erythema scores of 2 (6/6 animals) and 1 (3/6 animals) at 24 and 72 hour respectively; and oedema score of 1 (3/6 animals) at 24 hour observations. Edemal was fully reversible within 72 hours, and there was evidence of reversibility for erythema over the limited timeframe of the study.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin corrosion/irritation.

 

EYE IRRITATION

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,

 

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult Newzeland rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3 and 4 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No effects on the cornea or iris were observed in any animal at any observation period (all scores were 0). The average conjunctivae score was 0.89 at 24, 48 and 72 hour. The average chemosis score was 0.17 at 24, 48 and 72 hour. All observed effects were fully reversible in 4 days.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

 

Justification for classification or non-classification

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal or occular irritation.