Registration Dossier

Administrative data

Description of key information

The key acute oral study (Notox, 1999, No. 262575), conducted according to the toxic class method OECD 423 and GLP, involved gavage administration of a limit dose of 2000 mg/kg bw of the neat material to male and female rats. During 14-days observation no treatment-related effects were reported and the LD50 was determined to be in excess of 2000 mg/kg bw. In the key acute dermal study (Notox, 1999, No. 262586), conducted according to OECD 402 and GLP, the skin of male and female rats was in occluded 24-h contact with a single limit dose of 2000 mg/kg bw of the neat material. In the absence of any treatment-related observations, the LD50 was determined to be in excess of 2000 mg/kg bw. No inhalation studies are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Additional information

The key oral and dermal studies were the only studies available for these endpoints. Both were well conducted, well reported, relatively recent studies, and were compliant with GLP, so were therefore assigned Reliability 1.


Justification for classification or non-classification

Based on reliable data for the oral and dermal routes, D6 is not classified for acute toxicity according to the criteria of Regulation (EC) No. 1272/2008.