Registration Dossier

Administrative data

Description of key information

The acute oral LD50 is >2,000 mg/kg bw.
The acute dermal LD50 is >2,000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The substance has low acute oral and dermal toxicity.

In accordance with Rule 8.5 of Annex VIII of the REACH Regulation, a study of the acute inhalation toxicity is not required, since studies of acute toxicity via oral exposure and via dermal exposure have been provided. Furthermore, the potential for inhalation exposure to occur is considered negligible.

Justification for classification or non-classification

The acute oral LD50 is >2,000 mg/kg bw, therefore no classification for acute oral toxicity is required according to CLP.

The acute dermal LD50 is >2,000 mg/kg bw, therefore no classification for acute dermal toxicity is required according to CLP.

No acute inhalation toxicity data are available. Based on the low acute toxicity via both the oral and dermal routes of exposure, no classification for acute inhalation toxicity is proposed.

In the acute oral toxicity study, no clinical signs were observed, except for a transient decrease in size of faeces and/or decreased defecation in one animal during the first two days after dosing, which may have been due to the fasting period prior to dosing. There were no remarkable bodyweight changes nor gross pathology findings. Consequently, no classification for Single Exposure Specific Target Organ Toxicity is required under CLP.