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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: LD50 (male/female): 890 - 1275 mg/kg bw;  non-Guideline Study, Vernier et al., 1969. 
The test substance is of moderate toxicity after single ingestion.

Key value for chemical safety assessment

Additional information

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

Acute Oral Toxicity

In the key study, a non-GLP and non-Guideline study, male and female rats (Carworth Farms CFE), (range of weight: 87 to 117 g (females); 113 to 141 g (males), (10/sex/dose) were given a single oral dose (unspecified) of the test item (analytical purity unknown) at unknown dosages (Vernier et al., 1969). The test item was diluted in water (40% w/v) and administered at a maximum dose volume of 10 mL/kg bw. The animals were observed subsequently for a period of 7 to 14 days. There are no data available about gross pathology.

There are no data vailable for single animals about point in time of mortality. All deaths observed occured 30 min to 24 hours after oral doses.

Clinical signs were central nervous system stimulation followed by tremors and brief clonic convulsions. Death was preceded by signs of respiratory distress and convulsions. No data about body weight gain were specified.

Conclusion: Under the conditions of the study the acute oral median lethal dose (LD50) of the test item was found to be

890 mg/kg bw (761 - 1019 mg/kg bw) for female and

1275 mg/kg bw (1095 - 1455 mg/kg bw) for male rats.

Acute Dermal Toxicity

There are no data available. Due to the corrosivity of the test substance an acute dermal study is scientifically unjustified.

Acute Inhalation Toxicity

There are no data available. Due to the corrosivity of the test substance an acute inhalation study is scientifically unjustified.

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test for acute oral toxicity are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is considered to be classified for acute oral toxicity (R22, Harmful if swallowed) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

 

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

The available experimental test data for acute oral toxicity are reliable and suitable for the purpose of classification under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. As a result the substance is considered to be classified for acute oral toxicity (Cat 4, H302: Harmful if swallowed) under Regulation (EC) No.1272/2008, as amended for the 2nd time in Directive EC 286/2011.