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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral: LD50 >2000 mg/kg bw (EU Method B.1, OECD Guideline 401)
Inhalation: no data
Dermal: LD50 >2000 mg/kg bw (EU Method B.3, OECD Guideline 402)

Key value for chemical safety assessment

Additional information

Oral:In an acute oral toxicity study performed by RCC (634972, 1996) according to EU method B.1/OECD guideline 401, 2000 mg/kg bw of the test substance were administered by gavage (vehicle: polyethylene glycol) to 5 young Wistar rats per sex. The animals were observed for 14 days for lethality and clinical signs of intoxication.

There were no treatment related death, body weight changes, clinical signs or gross pathology findings. Hence, the LD 50 is > 2000 mg/kg bw for male and female rats.

 

Inhalation: There are no data available for acute inhalation toxicity.

 

Dermal:In an acute toxicity study conducted by RCC (634994, 1996) according to EU Method B.3/OECD Guideline 402, groups of 5 young male and female Wistar rats were dermally exposed to the unchanged test substance for 24 hours to 10% body surface at a dose of 2000 mg/kg bw. Animals were observed for 14 days. There were no treatment related death, clinical signs or gross pathology findings. Loss of weight was observed in three female animals during the first observation week and in 2 female animals during the second observation week. The slight loss of body weight observed in the first 3 animals was considered to be a consequence of the semi-occlusive dressing used during treatment. Commonly female animals prove to be more sensitive in relation to the effects on body weight caused by semi-occlusive dressing than male. These animals recovered during the second observation week. Hence, the LD50 is > 2000 mg/kg bw for male and female rats.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).