Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Skin irritation

In the key study for skin irritation, performed according to OECD TG 404 and GLP, undiluted lysmeral was applied dermally (semiocclusive) on 3 rabbits for 4 hours (RIFM 307 -338/8403). Erythema were found in all animals with a mean score (observation points 24, 48h, 72h) of 1.7, 2.0 and 2.3 for the respective animals. In line, edema were found in all animals with a mean score of 2.0, 2.7 and 3.0 for the respective animals. Findings were still present at the end of the observation period of 7 days and a marked desquamation in all animals was observed.

In a supportive study, occlusive dermal application of undiluted lysmeral on 2-3 rabbits for 5 minutes, 2 or 24 hours resulted in desquamation in all animals at the end of the observation period (8 days) for all exposure periods (BASF AG 79/166). Questionable to slight edema (reversible for all exposure periods) and erythema (reversible for 5 min exposure period) were observed whereas longer exposure periods led to persisting erythema at the end of the observation period.

Lysmeral has been included as chemical known to cause skin irritation in the validation exercises of different in vitro tests for skin irritation (Fentem 2001).

Eye irritation

In the key study, undiluted lysmeral was applied into one eye of 3 rabbits each without washing out after application and animals were observed daily for 72 hours (BASF AG 79/166). Slight conjunctival redness was found in all animals 24 hours after application and in 1 of 3 animals 48 hours after application, resulting in a mean score of 0.7 over all animals and observation time points. No adverse findings, i.e. chemosis, iritis or corneal opacity, were observed at any time point.

According to data from secondary sources with limited information on study details and results, lysmeral showed slight to moderate conjunctivitis when applied undiluted to one eye of 3 rabbits each (EPA (TSCAT) 1991).


Justification for classification or non-classification

In the chosen key study for dermal irritation, mean erythema scores were found to be above or equal to 2 in 2 of 3 animals and edema scores were found above or equal to 2.3 in 2 of 3 animals. Furthermore, adverse findings and a marked desquamation persisted during the observation period. The present data on dermal irritation fulfill the criteria for a classification as irritating to the skin (R38) in accordance with 67/548/EEC and as skin irritant (Category 2) according to GHS-CLP.

In the chosen key study for eye irritation, reversible slight conjunctival redness resulting in a mean score of 0.7 for all animals and observation time points was observed, whereas other adverse findings in eye were absent. The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC and GHS-CLP, and a non-classification is warranted.