Registration Dossier

Administrative data

Description of key information

skin irritation: not irritating to the intact skin of rabbits (BASF AG, 1971)
eye irritation: not irritating to the eye (BASF AG, 1971)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation
In a primary dermal irritation study, young adult Vienna White rabbits were dermally exposed to 0.5 mL of the undiluted test substance for 20 hours to the shaved dorsal or lateral part of the back under an occlusive dressing (BASF AG, 1971). Animals then were observed for 8 days. Irritation was scored by a BASF internal system after 24 hours. The results were converted into the Draize scheme. After a 20-hour application very slight erythema was observed in both animals with a mean score of 0.33 (24, 48, 72 h). No oedema was observed in either of the animals. After 8 days the erythema had resolved. The substance is regarded as not irritating to the intact skin of rabbits.

Eye irritation
In a second primary eye irritation study, 0.05 mL of the undiluted test substance was instilled into the conjunctival sac of two Vienna White rabbits (BASF AG, 1971). The test substance was not washed and the adjacent eye served as a control. Animals were observed for 8 days. Irritation was scored after 24 hours with a BASF internal system. The results were converted into the Draize system. The test substance caused slight conjunctival redness in both animals after 24 hours. A mean conjunctivae score of 1 (24, 48, 72 h) was determined for both animals. The redness had resolved after 8 days. No other eye effects were observed in both animals. The test substance is regarded as not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Scientifically acceptable study report. Basic data given.

Justification for selection of eye irritation endpoint:
Scientifically acceptable study report. Basic data given.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled as eye or skin irritating under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled as eye or skin irritating under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014