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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
24 mg/kg bw
Quality of whole database:
One high quality study is available and acceptable for the risk assessment. The most sensitive LD50 of both sexes, i.e., the LD50 of the females was used for the risk assessment.

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

The acute oral toxicity test (Coles 1990) was performed according to OECD 401 and EEC method B.1. This study is considered to be a Klimisch 1 key study. The test material has a purity of 102%. Five males and five female rat (Sprague-Dawley) were used per test group. The initial body weight ranged from 120 - 144g (males) and 126 - 159g (females) after overnight fasting. The administration was performed by gavage. Three groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 10, 20 and 40 mg/kg bodyweight. Deaths were noted one, two and five days after dosing. One male treated with 20 mg/kg was killed in extremis on day two. Common signs of toxicity noted in the 20 and 40 mg/kg dose groups were hunched posture, piloerection, lethargy, ptosis, ataxia and loss of righting reflex. Additional signs of toxicity noted in the 40 mg/kg dose group were decreased respiratory rate, body tremors, red/brown stains around the snout, dehydration and pallor of the extremities. Surviving animals appeared normal four days after dosing. Surviving animals showed expected gain in bodyweight during the study. Abnormalities noted at necropsy of animals that died or were killed in extremis during the study were haemorrhagic or abnormally red lungs, dark liver, dark kidneys, haemorrhage of the glandular gastric epithelium and haemorrhage of the small and large intestines. The male treated with 20 mg/kg that was killed in extremis also showed an enlarged and blood filled bladder at necropsy. No abnormalities were noted at necropsy of animals killed at the end of the study.

The LD50 (males and females) was 24 mg/kg bw, the LD50 (males) was 24 mg/kg bw and the LD50 (females) was 25 mg/kg bw.

 

This study was performed according to international guidelines and under GLP and fulfilled the validity criteria. Therefore, this study was considered to be Klimisch 1 study.

 

The obtained results are considered as relevant for the risk assessment.


Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

The substance needs to be classified, based on criteria of Annex VI of 92-32-EC and 1272-2008-EC.