Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw;  OECD Guideline Study, 2002
Acute dermal toxicity: LD50 > 2000 mg/kg bw; OECD Guideline Study, 2002

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
GLP and guideline study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Oral: In a GLP-compliant acute oral toxicity study (OECD 423), groups of fasted 8 week old rats (3/sex) were given a single oral dose of the unchanged test item at 2000 mg/kg body weight and observed for 14 days. No mortality occurred and normal body weight gains were found in this study. There were no signs of systemic toxicity and no abnormalities were noted at necropsy.

Dermal: In a GLP-compliant acute dermal toxicity study (OECD 402), groups of 8 week old rats (5/sex) were dermally exposed to undiluted test item for 24 hours to 10% of body surface area at 2000 mg/kg body weight. Animals then were observed for 14 days. No mortality occurred and normal body weight gains were found in this study. There were no signs of systemic toxicity or dermal irritation and no abnormalities were noted at necropsy.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.