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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The oral LD50 of the test material in female rats has been determined to be greater than 2500 mg/kg bw. 
The dermal LD50 of the test material in male and female rats has been determined to be greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

Oral

In a key acute oral toxicity study performed according to OECD Guideline 423, two groups of fasted Sprague-Dawley rats (three females/group) were given a single oral dose by gavage of undiluted test material at a dose level of 2000 mg/kg bw and observed for 14 days.

There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Gross pathologic examination revealed nothing remarkable. The oral LD50 of the test material in female rats has been determined to be greater than 2500 mg/kg bw.

Dermal

In a key acute dermal toxicity study performed to OECD Guideline 402, undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females) at a dose level of 2000 mg/kg bw. The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period any residual test material was removed and the animals were observed for 14 days.

There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Very slight erythema was noted at all treatment sites one and two days after dosing. Crust formation was noted at the treatment sites of three males and three females three to five days after treatment. Treatment sites appeared normal three or six days after treatment. Gross pathologic examination revealed nothing remarkable. The dermal LD50 of the test material in male and female rats has been determined to be greater than 2000 mg/kg bw.

Inhalation

According to REACH Annex XIII Section 8.5 information on acute toxicity will be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a liquid with a vapour pressure of 2.3 x10-8 Pa at 25°C and is used primarily as a component of lubricants and greases by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is, therefore, not required.

Justification for classification or non-classification

In an acute oral and an acute dermal toxicity study in the rat, no LD50 value could be determined up to and including the maximum dose level (2500 and 2000 mg/kg bw respectively).

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute toxicity