DS-2920A-E

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/003, 1998. 
The test substance is virtually nontoxic after a single oral administration. 
Acute dermal toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/054, 1998
The test substance is virtually nontoxic after a single dermal application.

Additional information

There are valid in vivo data available for the assessment of the acute oral and dermal toxicity of the test item.

Acute Oral Toxicity

In the key study, performed as a limit test according to GLP and OECD Guideline 401 (Acute Oral Toxicity), fasted, 8 to 12 weeks old, Sprague Dawley rats (Crl : CD ® (SD) IGS BR, 5/sex/dose) were given a single oral dose (gavage) of the test item (analytical purity unknown) at a single dose of 2000 mg/kg bw (Safepharm Laboratories Ltd, 1235/003, 1989). The test item was diluted in distilled water at a concentration of 0.2 mg/mL and administered at a volume dosage of 10 ml/kg. The animals were observed subsequently for a period of 14 days. All animals were killed and subjected to gross pathology. No mortality occurred during the observation period. No signs of systemic toxicity were noted during the study. The faeces of all animals and the urine of all females were stained orange one to two days after treatment. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Conclusion: Under the conditions of the study the acute oral median lethal dose (LD50) of the test item was found to be greater than 2,000 mg/kg body weight for male and female rats.

Acute Dermal Toxicity

In the key study,performed as a limit test according to GLP and OECD Guideline 402 (Acute Dermal Toxicity), 8 to 12 weeks old Sprague Dawley rats (Crl : CD ® (SD) IGS BR, 5/sex/dose) were given a single semi-occluded dermal application at a dose level of the test item (analytical purity unknown) of 2000 mg/kg bodyweight (Safepharm Laboratories Ltd, 1235/054, 1989). The exposure period was 24 h and the observation period 14 days. No mortality occurred during the observation period. There were no signs of systemic toxicity or skin irritation during the study. There were no treatment related necropsy findings or changes in body weight.

Conclusion: Under the conditions of the study the acute dermal median lethal dose (LD50) of the test item was found to be greater than 2,000 mg/kg body weight for male and female rats.

 

Acute Inhalation Toxicity

There are no data available. Due to the physicochemical characteristics and taking into account that the substance shows no general toxic potential after acute oral and dermal application, an acute inhalation study is scientifically unjustified.

 

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute oral or dermal toxicity is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute oral or dermal toxicity is not warranted under Regulation (EC) No.1272/2008.