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Administrative data

Description of key information

LD50 (oral, rat) > 5000 mg/kg bw 
LC50 (inhalation, rat) > 11 mg/L air
LD50 (dermal, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Additional information

Oral route:

Two studies on the structurally similar substance DBE (EC# 906-170-0) both of reliability 1 according to Klimisch cotation criteria, are available for oral route (Pooles, 2006 and Clouzeau, 1987). The 2006 study was selected as the key study since the tested dose (5000 mg/kg) was higher than that tested in the other study (2000 mg/kg), although 2000 mg/kg was administered to a higher number of test animals of both genders (5 male and 5 female rats compared to 3 female rats). No death occurred during the 2-week observation period in either study. The LD50 for oral route in rats was higher than 5000 mg/kg. No classification for acute oral toxicity is therefore warranted on the basis of these in vivo data.

 

Inhalation route:

One study on the structurally similar substance DBE(EC# 906-170-0), of reliability 2 according to Klimisch cotation criteria, is available for inhalation route (Valentine, 1990). Following a 4-hour nose-only exposure of 5 male and 5 female rats to concentrations up to 11 mg/L, no death occurred during the 2-week observation period. The 4-hour LD50 for inhalation in rats was higher than 11 mg/L. No classification for acute inhalation toxicity is therefore warranted on the basis of these in vivo data.

 

Dermal route:

Two studies are available for dermal route on the structurally similar substance DBE(EC# 906-170-0).

One study in rats (Clouzeau, 1987) was of reliability 1 according to Klimisch cotation criteria and was therefore selected as the key study. The other study, conducted in rabbits (Ford, 1981) was considered of low reliability (3) due to major uncertainties. In the rat study, no deaths occurred following dermal application of 2000 mg/kg for 24 hours to 5 males and 5 females during a 2-week observation period. Similarly in the rabbit study, no deaths occurred following dermal application of doses up to 2250 mg/kg for 24 hours to 6 males during a 2-week observation period. Based on the key study, the LD50 for dermal route in rats was higher than 2000 mg/kg. No classification for acute dermal toxicity is therefore warranted on the basis of these in vivo data.

Justification for classification or non-classification

Due to the absence of mortality following exposure of rats to limit test doses or concentrations and a 2-week observation period whatever the route of administration, no classification for acute toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).