Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, semiocclusive: not irritating (GLP, OECD 404; BASF 1991)
eye
rabbit, 0.1 mL, not rinsed: not irritating (GLP, OECD 405; BASF 1991)

Key value for chemical safety assessment

Additional information

skin

In a primary dermal irritation study according to OECD test guideline 404 and following GLP requirements, three White Vienna rabbits were dermally exposed to 0.5 mL of unchanged Keroflux ES 3241 (purity not reported) for four hours to 2.5*2.5 cm of intact skin under semiocclusive conditions (BASF AG 1991). Animals then were observed for 15 days. Irritation was scored by the OECD/Draize method. Mean erythema and edema scores of the relevant 24, 48 and 72 h readings were 1.2 and 0.0; erythema were reversible at most within 15 d. Scaling was observed in 1 of 3 animals at the final reading. Keroflux ES 3241 is therefore not considered as skin irritant.

eye

In a primary eye irritation study according to OECD test guideline 405 and following GLP requirements, 0.1 mL of unchanged Keroflux ES 3241 (purity not reported) was instilled into the conjunctival sac of the left eye of three White Vienna rabbits (BASF AG 1991). The eyes were not washed out. Animals then were observed for three days until all observed effects were resolved. Irritation was scored by the OECD/Draize method. Mean scores for cornea opacity, iritis, conjunctivae redness and chemosis were 0, 0, 0.6 and 0 for the relevant readings 24, 48 and 72 hours after instillation. Slight conjunctivae redness was reversible within at most 72 h.Keroflux ES 3241 is therefore not considered as eye irritant.



Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

According to the conditions and results of the available tests, Keroflux ES 3241 has not to be classified as skin and eye irritant according to 67/548/EEC and UN-GHS, respectively.