Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 combined oral LD50 in male and female rats was 1740 mg/kg bw, in males 1780 mg/kg bw and for females 1540 mg/kg bw.
Inhalation of saturated vapour for 7 hrs in rats resulted in slight clinical signs but in no mortality in the inhalation hazard test.
In a limit test on acute dermal toxicity in rats no clinical signs were reported at a dose of 2000 mg/kg bw; LD50 is >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 740 mg/kg bw

Additional information

Oral

In a study comparable to OECD 401 groups of 5 rats per sex and dose group were administered with 2150, 1780, 1470, 1000 and 464 mg/kg bw of the test substance. The acute LD50 of the test substance in rats was found to be 1740 mg/kg bw for male and female animals combined, the LD50 for males was 1780 mg/kg bw and for females 1540 mg/kg bw. Within 30 min after administration, dyspnoea, apathy, staggering gait, ruffled fur and poor general condition was observed in the lowest dose group; no signs were seen after 4 h. In the higher dose groups, dyspnoea, apathy, abnormal position, staggering gait, atony, loss of pain and corneal reflex, narcosis like condition, ruffled fur, cyanosis, dehydration and poor general condition was observed. No signs were observed 2 day after administration, except ruffled fur was noted in 1000 and 1470 mg/kg bw dose group till day three and 6, respectively. Substance caused congestion and hyperemia in animals that died, but necropsy revealed no effects in survivors (BASF 1984).

Inhalation

In a study comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) 6 rats (3 males and 3 females) were exposed for 7 hrs to a vapour saturated atmosphere (room temperature) at mean nominal concentration of 0.86 mg/L. No mortality was observed. Within 3 minutes after start of exposure and during the whole exposure period accelerated respiration was seen in 6/6 rats; 3 -30 minutes after start of exposure snout wiping was observed in 3 rats and 10 minutes after start trembling in 4 rats (not in later recordings). No clinical signs were detected after exposure and during the post exposure observation period of 14 days. No pathological changes were observed at necropsy (BASF 1988).

.

Dermal

In a limit test on acute dermal toxicity (comparable to OECD Guideline 402) 5 male and 5 female Wistar rats were exposed to 2000 mg/kg bw for 24 h (semi-occlusive); the post exposure observation period was 14 days. No clinical signs, no mortality, and no effects on body weight were recorded. Necropsy revealed no findings (BASF 1988).

Justification for classification or non-classification

Based on the available acute oral data, the substance is classified for acute toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 with cat. 4 (H302).