Registration Dossier

Administrative data

Description of key information

3 Acute oral toxicity studies, 3 Acute Dermal toxicity studies including registered substance and major component as well as 1 acute inhalation study on major component. 
In an acute oral study (KS) no mortality was seen in treated male and female rats. Oral LD50 was > 5000 mg/kg. Based on available acute dermal studies, dermal LD50 is > 2000 mg/kg limit dose.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
acceptable

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
limited

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
acceptable

Additional information

The acute toxicity of this substance has been assessed by all three routes of exposure. The acute toxicity of this substance is low with the LD50 values for oral and dermal dose routes (in the rat) being greater than limit dose, with highest doses > 8 g/kg and > 4 g/kg respectively.

In the KS with registered substance, the oral LD50 value was > 5 g/kg in male and female rats. Clinical signs following oral administration were observed only in the animals dosed with 4 and 8 g/kg bw and persisted only until the second day after dosing. There were no clinical signs in those animals treated with lower doses. This is consistent with the other acute oral studies available on this substance and a thermally degraded form.

Dermal application appeared to produce clinical signs of toxicity and stress at doses lower than those following oral dosing. However, the clinical signs are likely associated with stress following application of the material rather than signs of systemic toxicity. Additional data from rabbits supports the LD50 being in excess of 2 g/kg bw.

The acute inhalation toxicity data is limited, with minimal information on methods. A non-standard dose schedule was used - two 1 hour exposures rather than a single 4 hour exposure. It is also unclear what the time between the dosing was. However, exposure to vapour containing 1.6 mg/l (approx 1600 mg/m3) of test material was not acutely toxic under the exposure conditions. Considering the low oral and dermal toxicity and the lack of clinical signs (other than some minimal excitability) in this study it is likely that the acute inhalation toxicity of this substance is also low.

Justification for classification or non-classification

No classification for acute toxicity is necessary.