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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 
rabbit, 4 h, occlusive: mildly irritant (OECD 404, BASF 1983)

eye
rabbit, eyes not rinsed: not irritant (OECD 405; BASF 1983)

Key value for chemical safety assessment

Additional information

There are reliable data from animal studies available to assess the skin and eye irritation potential of the test substance.

skin

In a study following the former version of the OECD guideline 404 using occlusive conditions, shaved skin areas of three Vienna White rabbits received ca. 0.5 mL of the unchanged test substance (purity unknown). The skin areas were treated for 4 hours under occlusive conditions before washing. The individual erythema score were 1.0, 1.7 and 2.0 during the relevant reading period (24 -72 h) and the corresponding edema scores were 0.0, 0.0 and 0.7 (scores according to the OECD/Draize scheme). Erythema and edema were completely reversible within 8 days and 48 hours, respectively. Desquamation was observed in all three animals at the final reading after 8 days. Under the conditions of the test, the test substance fulfilled the criteria as "mildly irritant to the skin" following GHS requirements (BASF 1983).

eye

In a study according to OECD guideline 405, 100 µL of the unchanged test substance (purity unknown) was instilled into the conjunctival sac of the right eyes of three Vienna White rabbits; the eyes were not rinsed. The eyes were scored at 1 h, 24 h, 48 h, 72 h, and 8 d after instillation. Findings were evaluated according to the OECD/Draize scheme. The untreated left eye of each rabbit served as control. No effects were seen at the cornea and iris. Redness (up to score 2, “well defined”) of the conjunctivae, swelling of the conjunctivae and secretion was noted. The individual scores during the relevant reading period (24-72 h) were 0.3, 1.3 and 1.7 for conjunctivae redness, 0.0, 0.3 and 0.3 for swelling of the conjunctivae and three times 0.3 for secretion, respectively. All eyes were normal by day 8 (BASF 1983).

Justification for classification or non-classification

Following the available test result, the test substance has not to be classified as skin irriating according to 67/548/EEC, but as mild skin irritant (Cat. 3) according to GHS requirements.

According to the available test result, the test substance has not to be classified as irriating to the eye according to 67/548/EEC and GHS requirements, respectively.