Registration Dossier

Administrative data

Description of key information

No acute toxicity studies are available on the substance. However, in a 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, and the NOAEL identified in this study was 1000 mg/kg bw/day. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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

According to the methodology described by Bulgheroni et al., 2009, non toxic compounds (LD50>2000 mg/kg bw) could be identified with NOAEL value from 28-day repeated dose toxicity studies. The NOAEL threshold ≥ 200 mg/kg bw/day could identify 63% of non toxic compounds. The registered substance fully complies with those criteria as a NOAEL of 1000 mg/kg bw/day was obtained in a 90-day repeated dose toxicity study (higher NOAEL in a longer study). Also, in this recent 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, for 90 consecutive days. Based on these elements, the registered substance is expected to have very low acute toxicity (LD50>2000 mg/kg bw) and the conduction of in vivo acute oral and dermal toxicity studies are therefore not deemed necessary.

Justification for classification or non-classification

According to the methodology described by Bulgheroni et al., 2009, non toxic compounds (LD50>2000 mg/kg bw) could be identified with NOAEL value from 28-day repeated dose toxicity studies. The NOAEL threshold ≥ 200 mg/kg bw/day could identify 63% of non toxic compounds. The registered substance fully complies with those criteria as a NOAEL of 1000 mg/kg bw/day was obtained in a 90-day repeated dose toxicity study (higher NOAEL in a longer study). Also, in this recent 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, for 90 consecutive days. Based on these elements, the registered substance is expected to have very low acute toxicity (LD50>2000 mg/kg bw) and it is considered that it does not require any classification for acute toxicity according to CLP regulation (EC) n°1272/2008.