Registration Dossier
Registration Dossier
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EC number: 692-842-6 | CAS number: 1312296-85-7
Endpoint summary
Administrative data
Description of key information
LD50 oral, rat: > 300 < 2000 mg/kg (BASF SE 2011)
Key value for chemical safety assessment
Additional information
The key study was performed according to OECD guideline 423 in compliance with GLP (BASF SE, 2011). In this acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item (preparations in doubly deionized water) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner.
The following test substance-related clinical observations were recorded:
- 2000 mg/kg (single test group): Mortality in all animals, impaired general state in one out of three animals, poor general state in all animals, dyspnoea in all animals, piloerection in all animals, abdominal position in two out of three animals, lateral position in one out of three animals, extension spasm in two out of three animals, rolling convulsions in all animals, tremor in one out of three animals, Straub phenomenon in one out of three animals.
- 300 mg/kg (first test group): No mortality occurred. No clinical signs were observed in the first test group dosed with 300 mg/kg bw.
- 300 mg/kg (second test group): No mortality occurred, impaired general state in all animals, poor general state in two out of three animals, dyspnoea in all animals, piloerection in all animals, staggering in two out of three animals, tremor in one out of three animals.
The mean body weight of the surviving animals increased within the normal range throughout the study period. The following macroscopic pathological findings were observed in the animals that died (2000 mg/kg; 3 females): Dark spotted discoloration of all lung lobes, yellowish discoloration of the stomach content, gaseous stomach, red discoloration of the glandular stomach, red discoloration of the small intestine. There were no macroscopic pathological findings in animals sacrificed at the end of the observation period (300 mg/kg; 6 females).
Conclusion: The acute oral LD50 was calculated to be LD50, oral, rat > 300 mg/kg < 2000 mg/kg bw.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC):
The available experimental test data for oral toxicity are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is classified for acute oral toxicity (Xn, R22).
No classification is warranted concerning acute dermal or acute inhalation toxicity due to lacking data.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:
The available experimental test data for oral toxicity are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. As a result the substance is classified for acute oral toxicity (Cat 4, H302, Harmful if swallowed).
No classification is warranted concerning acute dermal or acute inhalation toxicity due to lacking data.
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