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Administrative data

Description of key information

Oral
LD50 794 mg/kg bw, similar to OECD 401, rat, Powers (1969)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
794 mg/kg bw
Quality of whole database:
The study was awarded a reliability score if 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997). The quality of the database is therefore considered to be adequate.

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

Oral

This endpoint has been addressed with two one key study (Powers, 1969) which has been assigned a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

The potential of the test material to cause acute toxicity via the oral route in the rat was investigated in a study which was conducted using methodology broadly equivalent to the standardised guideline OECD 401.

Male Carworth (Sprague-Dawley derived) rats were exposed to the test material via gavage at dose levels of 100, 215, 464, 1000, 2150 and 4640 mg/kg/bw as a 10 % weight per volume suspension in corn oil. Five rats were exposed per dose level. Mortality and toxic effects were recorded immediately after dosing; at one, four, and 24 hours; and once daily thereafter for a total of seven days. Body weights were recorded at study initiation and again at termination.

After a seven-day observation period, animals were sacrificed and gross necropsy performed on all animals which died during the study and on those sacrificed at termination.

There were no mortalities at the 100, 215 and 464 mg/kg dose levels. At the 1000 mg/kg dose level, 3 animals died 24 hours after administration, followed by a further death during the 6 day observation period. At the 2150 mg/kg dose level, 4 animals had died at the 4 hour observation, followed by a further death during the 6 day observation period. At the 4640 mg/kg dose level, 4 animals had died at the 4 hour observation, followed by a further death by the end of the 24 hour period. At the 100 and 215 mg/kg dose levels, no effects were observed.

Under the conditions of this study, the LD50 was determined to be 794 mg/kg/bw with confidence limits of 584 to 1080 mg/kg.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to acute oral toxicity as Category 4 (H302; Harmful if swallowed).