Registration Dossier

Administrative data

Description of key information

Based on the oral LD50 >2000 mg/kg bw, the test substance is not considered to be harmful or toxic by oral or dermal routes.

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:
Guideline compliant study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observation and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Hunched posture and/or piloerection were noted for three animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, no abnormalities were found at macroscopic post mortem examination. Under the study conditions, the rat oral LD50 for the test substance was considered to exceed 2000 mg/kg bw (van Huygevoort, 2016).

Justification for classification or non-classification

Based on the results of an acute oral toxicity study, the test substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC) criteria.