Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity study the test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten male and ten female rats in one single dose of 25 ml/kg body weight.  The rats were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors. Four male and 1 female rats died. The LD50 is > 10000 mg/kg bw.

No acute inhalation or dermal toxicity studies are available.

According to Commission Regulation (EU) 2016/863 of May 2016, (point 8.5 of Annex VIII) for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Based on the physicochemical data (vapour pressure of the substance is  of 1.0E-4 Pa at 50°C (measured), water solubility of  0.07 mg/l at 20 °C and the log Kow of 3.4 at 20 °C testing by dermal route seems appropriate.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
Study well documented, meets generally accepted scientific principles, acceptable for assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In an acute oral toxicity study theLD50 for male and female rats was >10000 mg/kg body weight.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified for acute oral and dermal toxicity.