Registration Dossier

Administrative data

Description of key information

The acute oral LD50 was estimated to be in the range of 300 - 2000 mg/kg bodyweight, as determined in a reliable study conducted according to current OECD guideline and in compliance with CLP (Harlan 2012). 
An acute inhalation LC50 of 1485 ppm (equivalent 5.2 mg/l) bw is reported in a reliable study conducted according to a protocol equivalent to current guideline, but not in compliance with GLP (Terrill, 1989).
An acute dermal LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to current OECD guideline and in compliance with GLP (Harlan 2013).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
5 231 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Additional information

The key study for acute oral toxicity reports an LD50 value between 300 and 2000 mg/kg bw in rat (Harlan 2013). The one animal which was dosed at the 2000 mg/kg bw dose level was killed due to severity of clinical signs thirty minutes after dosing. These signs included laboured respiration, decreased respiratory rate, hypothermia and pallor of the extremities and the test animal was also comatose. Haemorrhage and epithelial sloughing of the non-glandular epithelium of the stomach and clear fluid present in the stomach were noted at necropsy. There were no deaths at the 300 mg/kg bw dose level. No signs of systemic toxicity were noted during the observation period. All animals showed expected gains in bodyweight over the observation period. No abnormalities were noted at necropsy in the animals dosed at 300 mg/kg bw. A reliability 4 supporting study for acute oral toxicity was also available with limited data reported (Deichmann 1969). The study reports an acute oral LD50 of 3800 mg/kg bw.

A reliability 4 study for acute inhalation toxicity is available with limited data reported (Deichmann 1969). The study reports an acute inhalation LC50 of 22 mg/l bw. No classification for acute inhalation toxicity is proposed due to the low relaibility of the only inhaled study available.

The key study for acute dermal toxicity reports an LD50 value of >2000 mg/kg bw in rat. There were no deaths during the study. There were no signs of systemic toxicity or dermal irritation. All the animals showed expected gains in bodyweight over the study period, except for one female which showed expected gain in bodyweight during the first week but no gain in bodyweight during the second week. No abnormalities were noted at necropsy.

A reliability 4 supporting study for acute dermal toxicity was also available with limited data reported (Deichmann 1969). The study reports an acute dermal LD50 of 4500 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Conducted according to an appropriate OECD guideline and to GLP.

Justification for selection of acute toxicity – inhalation endpoint
The only study available. (secondary source and therefore reliability 4).

Justification for selection of acute toxicity – dermal endpoint
Conducted according to an appropriate OECD guideline and to under GLP.

Justification for classification or non-classification

Based on the available reliable data, classification is required for acute oral toxicity Category 4, H302: Harmful if swallowed, in accordance with current EC Regulation No. 1272/2008. No classification is required for acute dermal or inhalation toxicity based on the available data.