Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50, rat: > 2000 mg/kg bw
Acute dermal toxicity: LD50, rat: > 2000 mg/kg bw
Acute inhalation toxicity: There are no data available concerning acute inhalation toxicity.

Key value for chemical safety assessment

Additional information

Oral:

In the key study that was performed according to OECD guideline 423 in compliance with GLP in male and female Sprague-Dawley rats the LD50 was determined to be > 2000 mg/kg bw (BASF AG, 2007). No mortality occured. The only observed clinical sign was slight piloerection shortly after dosing. Nothing abnormal was detected concerning body weight and gross pathology.

Dermal:

In the key study that was performed according to OECD guideline 402 in compliance with GLP in male and female Wistar rats the LD50 was determined to be > 2000 mg/kg bw (BASF SE, 2009). No mortality occured. No systemic clinical signs were observed during clinical examination. The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week. The mean body weight of the male animals increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation. Local skin effects (erythema, edema, scaling and encrustations) were observed one day after application of the substance through to the end of the observation period.

Inhalation:

There are no data available concerning acute inhalation toxicity.

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- Oral route: conclusive, but not sufficient for classification

- Dermal route: conclusive, but not sufficient for classification

- Inhalation route: data lacking