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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Two skin irritation studies are available, one according to the OECD guideline 404 (BASF AG, 1992; #AG18H0017/912090) and one non-guideline study (BASF AG, 1976; #XVII/217; test substance applied 20 h under occlusive conditions on intact skin, 8 days observation period). Two eye irritation studies are also available (BASF AG, 1976: #XVII/217; Ciba-Geigy, 1986: #TK13047/1B), one a according to OECD guideline 405 (Ciba-Geigy). The substance is neither irritating to the eye nor to the skin.

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 the first study conducted according to the OECD guideline 404 (Acute Dermal Irritation/Corrosion; BASG AG, 1992: 18H0017/91090), although the 4 hour reading could not be performed due to staining of the skin by the test substance, no animal exhibited erythema or edema (grade 0) from the 24 h reading onward. In the second study (BASF AG, 1967: XVII/217) the test substance was applied to a 2.5 x 2.5 cm application site (intact skin) of white rabbits for 20 h under occlusive conditions and the animals were observed for 8 days. Findings were recorded after 24, 48, 72 hours and until the end of the observation period, and graded as described in OECD test guideline 404. The erythema and edema scores were 0 during the entire course of the observation period, and, apart from red to brawn coloration of the skin by test substance, no adverse effects observed.

Eye irritation:

In the first study conducted according to the OECD guideline 405 (Acute Eye Irritation/Corrosion; Ciba-Geigy Ltd, 1986: TK 1304/1B), following observations (mean 24-48-72 hour scores) were made: cornea score (0.44), iris score (0), conjunctiva score (redness; 1.25) and chemosis score (0.67), and were all fully reversible within 3 to 14 days. In the second study BASF study (#XVII/217) 50 mg test substance was applied the right eye of 2 test animals (no wash out; for negative control, the left eyes of the same animals were treated with 50 mg talcum powder) and the animals were observed for 8 days. Findings were recorded after 24, 48, 72 hours and until the end of the observation period, and graded as described in OECD test guideline 405. Test substance coloration of the eyes was observed up to 3 hours after treatment with slight chemosis (score: 1 after 1 hour in one animal and after 3 hours in the second, but completely reversible after 3 and 24 hours respectively). From 24 hours onwards, all irritation parameters (cornea score, iris score, conjunctiva score and chemosis score) were 0 during the entire course of the observation.

Respiratory irritation:

No data available

Justification for classification or non-classification

Based on the available data classification for this endpoint is not warranted.