Registration Dossier

Administrative data

Description of key information

Acute toxicity has been tested with the solid commercial material of 1978. The solid test material was described to be 100% and identified by the trade name.

Testing was done prior to the introduction of GLP and OECD testing guidelines. The method for acute oral toxicity is identical to the set-up outlined in OECD guideline 423. Doses of 2150 and 5000 mg/kg bw was tested in each five female and five male rats, and one female rat died one day after dosing with 5000 mg/kg bw. The other animals recovered and survived until the scheduled sacrifice 14 days after dosing. Therefore, the LD50 was determined to be greater than 5000 mg/kg bw in female rats. Animals of both dose groups had blue faeces and urine during the first 24h after dosing. Clincial symptomes were observed on the first day only. There were no findings at necropsy.

The same test material as for the acute oral study was used to determine the LD50 for intraperitoneal injection in mice; the LD50 (i.p.) was 900 mg/kg bw.

No adverse effects were observed in male and female rats breathing an uncharacterized atmosphere obtained by blowing air through a layer of the above used test material for seven hours. From the loss of material, a mean dose of 8.7 mg//L was calculated. Due to the lack of characterization of the test atmosphere, this study is not suited to conclude on the absence of an acute inhalation hazard.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 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

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. One case of mortality occurred at the limit dose of 5000 mg/kg bw. As a result the LD50 is greater than 2000 and 5000 mg/kg bw and the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.

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