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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Kesla Forschung & Service KG, Report No. A03974, 2001-04-10]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Kesla Forschung & Service KG, Report No. A03975, 2001-04-10]

Key value for chemical safety assessment

Additional information

The single oral administration of the test substance (ZK 57797) to male and female rats at a dose of 2000 mg/kg and to female rats at a dose of 200 mg/kg led to death of one female animal of the 2000 mg/kg dose group died. All other treated animals survived the 14 day observation period. Strong clinical signs were observed only in female animals of the 2000 mg/kg dose group (rough hair coat, squatting abdominal or lateral position, apathy, coma) shortly after administration until three days after administration. None of the male animals and of the female animals of the 200 mg/kg dose group showed alterations of the general state of well-being. The body weight gain was not affected in the surviving animals with exception of one female animal of the high dose group. In this case it was normal during the first week but decreased in the second week. Only the died female animal showed macroscopic pathological findings (stomach content grey and thin-mushy, small intestine mucous membrane partial haemorrhagic, lung haemorrhagic infarcted).

The acute oral toxicity of Hydroxypropyltesto in rats is above 2000 mg/kg body weight.

The single dermal administration of the test substance (ZK 57797) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality, clinical signs, body weight changes or pathological findings.

The acute dermal toxicity of Hydroxypropyltesto in rats is therefore above 2000 mg/kg body weight.

Moreover, no compound-related local findings were observed. None of the animals showed alterations of the skin (edema and/or erytthema) on the administration area.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.