Registration Dossier

Administrative data

Description of key information

Skin

In vivo

Rabbit (m/f) (OECD 404): not irritating (BASF AG, 1984)

in vitro

Actually there is no date available

Eye

In vivo

Rabbit (m/f) (OECD 405): not irritating (BASF AG, 1984)

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

The following considerations based on the similar substance are also applicable to the target substance. For read across justification see the relevant document in the read across section

There are valid in vivo data available for the assessment of the skin and eye irritation potential of the test substance.

Skin

The potential of the test substance to cause acute dermal irritation or corrosion was assessed in vivo in rabbits according to OECD guideline 404. In this study the test article did not show any irritative/corrosive potential by a single topical application of 0.5 g of the test substance to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive conditions. The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema, with the erythema being fully reversible within 48 hours.

 

Eye

The potential of the test substance to cause eye irritation or corrosion was assessed in 3 rabbits according to OECD guideline 405. The test substance produced moderate conjunctival reactions (reddening and swelling) were observable in all animals for 24 h after exposure, however, the eye was exposed to bulk volume (powder) of the test substance, thus, initial irritation can be explained by mechanical effects. Those effects were fully reversible within 8d. No other effects were reported.

 

 

Justification for classification or non-classification

The following considerations based on EC 400 -720 -9 are also applicable to EC: 700- 899 -6. For read across justification see the relevant document in the read across section

Skin

Based on the results of the in vivo experiments, the test substance needs not to be labelled according to the criteria defined by the EU and the GHS system

 

Eye

Based on the results of the in vivo experiments, the test substance needs not to be labelled according to the criteria defined by the EU and the GHS system

 

Respiratory system

There is no indication given for a classification according to this endpoint