Registration Dossier

Administrative data

Description of key information

In a reliable acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 5 g/kg bw (single administration). There were no mortalities or signs of clinical toxicity, changes to mean body weight gain was not of toxicological significance and no abnormalities were found at macroscopic post-mortem examination.The LD50 is 5 g/kg bw. In an unreliable acute oral toxicity study Sprague Dawley rats received the substance at a concentration of 20 ml/kg bw with no mortality being observed.

In a reliable acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by inhalation exposure at a dose level of 5 mg/L (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LC50 is 5 mg/L. In an unreliable acute inhalation toxicity study Sprague Dawley rats received the substance at a concentration of 201.09 ml/kg bw with no mortality being observed.

In a reliable acute toxicity study the substance was administered to New Zealand White rabbits (5 animals/sex/dose) by dermal application at a dose level of 5 g/kg bw (single administration). The animals were examined daily for 15 days post dosing. There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is 5 g/kg bw. In an unreliable acute dermal toxicity study New Zealand White rabbits received the substance at a cooncentration of 8 g/kg bw with no mortality being observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Sufficient to address requirement.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
5 000 mg/m³
Quality of whole database:
Sufficient to address requirement.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Sufficient to address requirement.

Additional information

Justification for classification or non-classification

Based on the findings of reliable acute toxicity studies (inhalation/oral/dermal) conducted on the substance, classification of the substance is not justified.