Registration Dossier

Administrative data

Description of key information

Oral:

The oral LD50 value of test item in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
300 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 study is available. According to the OECD 423 test guideline, initially, the test substacne was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure three additional groups of three females were dosed at 300 mg/kg body weight.

Initially, test item was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 300 mg/kg body weight.

At 2000 mg/kg, two animals were found dead on Day 1 and one animal was found dead on Day 2. At 300 mg/kg, one animal was found dead on Day 2. No further mortality occurred.

At 2000 mg/kg, lethargy, clonic spasms, lateral recumbency, hunched posture, uncoordinated movements, slow breathing, shallow respiration, piloerection, salivation, watery discharge from both eyes, pale appearance and/or ptosis were noted for all animals on Day 1. At 300 mg/kg, lethargy, flat posture, hunched posture, laboured respiration, gasping, piloerection, chromodacryorrhoea (mouth and nose) and/or ptosis were noted on Days 1 and/or 2.

The mean body weight gain shown by the surviving animals over the study period was considered to be normal.

Abnormalities of the lungs (swollen and several dark red foci) were found in the animal dosed at 300 mg/kg that died during the study, at macroscopic post mortem examination.

Macroscopic post mortem examination of the other animals that died during the study and of the surviving animals at termination did not reveal any abnormalities.

The oral LD50 value of test item in Wistar rats was established to be within the range of 300-2000 mg/kg body weight, the LD50 cut-off value was considered to be 500 mg/kg body weight.

Justification for classification or non-classification

Oral LD50: 300-2000 mg/kg body weight

Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should be classified as Category 4.

 

Specific target organ toxicity-single exposure:

Death: At 2000 mg/kg, two animals were found dead on Day 1 and one animal was found dead on Day 2. At 300 mg/kg, one animal was found dead on Day 2.

Clinical observation: At 2000 mg/kg, lethargy, clonic spasms, lateral recumbency, hunched posture, uncoordinated movements, slow breathing, shallow respiration, piloerection, salivation, watery discharge from both eyes, pale appearance and/or ptosis were noted for all animals on Day 1. At 300 mg/kg, lethargy, flat posture, hunched posture, laboured respiration, gasping, piloerection, chromodacryorrhoea (mouth and nose) and/or ptosis were noted on Days 1 and/or 2.

Macroscopic Findings:Abnormalities of the lungs (swollen and several dark red foci) were found in the animal dosed at 300 mg/kg that died during the study, at macroscopic post mortem examination.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should be classified as Category 2.