Registration Dossier

Administrative data

Description of key information

Oral:

The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
1

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:

One in vivo test is available in complied with OECD No.423. The test item was administered by oral gavage to three female Wistar rats at 300, 300, 2000 and 2000 mg/kg body weight in a stepwise procedure.

No mortality occurred.

Hunched posture and piloerection was noted for all animals between on Days 1 and/or 2. Additionally, uncoordinated movements and/or chromodacryorrhoea of the snout was noted for three animals treated at 300 mg/kg on Day 1.

The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Justification for classification or non-classification

Oral LD50: >2000 mg/kg bw

Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1, this substance should be not classified for this endpoint.

 

Specific target organ toxicity-single exposure:

No significant non-lethal toxic effects observed in acute oral toxicity study.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1, this substance should not be classified for this endpoint.