Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: considered as Category 1C (Corrosive)
Eye irritation: considered as Category 1 (Irreversible effects on the eye)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation/corrosion

Four studies were available:

1) A DOT skin corrosion study (Nitka, 1990) is available which is key study.

The substance was administered neat to unabraded skin for 4 hours and clear signs of corrosion were shown in all animals.

2) A primary skin irritation study (Romanelli, 1990) is available which is supporting study.

The substance was administered neat to skin for 24 hours, one site was left intack and the other received minor epidermal abrasions . The substance was clearly a dermal irritant and showed signs indicating skin corrosion.

3) A primary dermal irritation study (Lewis, 1978) is available which is supporting study.

The substance was administered neat to both abraded and unabraded skin for 24 hours. The substance was clearly a dermal irritant and showed signs indicating skin corrosion. This study clearly supports the findings of the key study.

4) A primary dermal irritation study (Nitka, 1986) is available which is supporting study. This study showed slightly irritating when used a 2% aqueous suspension.

Eye irritation

An eye irritation toxicity studies with rabbit (Nitka, 1986) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) was conducted according to modification of that described by J.H. Draize. Key study.

This study showed that the test substance is a severe ocular irritant to rabbits under conditions of this test.

A primary ocular irritation study (Nitka, 1986) is available which is supporting study. This study showed the test substance is not irritating when used a 2% aqueous suspension.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation/corrosion: A primary skin irritation study give a corrosive result after 4 hours of exposure (Nitka, 1990). Classification with Category 1A and 1B is not considered justifiable as according to Regulation (EC) No. 1272/2008 Tables 3.2.1 this is only applicable where exposure time is <=3 minutes (Category 1A) and >3 minutes -<= 1 hour (Category 1B).  The shortest actual exposure duration was 4 hours (Nitka, 1990).

Serious eye damage/eye irritation: At least one animal exhibited effects on the cornea (6 of 6 animals), iris (5 of 6 animals) and conjunctiva (5 of 6 animals) after 21 day (Nitka, 1986, on an analog substance).

Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.2.1 & Section 3.3.2.4 the substance is classified as "Category 1C (Corrosive)" for the skin corrosion/irritation endpoint and Category 1 for the serious eye damage/eye irritation endpoint.