Registration Dossier

Administrative data

Description of key information

oral: LD50 (male) = 1790 mg/kg bw

inhalation: LD50 (male/female)= 3.82 mg/l

dermal: LD50 (male/female) = 3000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 790 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
3 820 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Additional information

The acute toxicity of the substance was evaluated for the oral, dermal and inhalation route by considering data on the substance and on a similar substance.

Acute toxicity-oral route

Two studies are available, one with the target substance and one with the similar substance. In both studies no guideline was followed. The rats were exposed to the susbtance after which they were observed for mortality. The LD50 found for the target substance is 1790 mg/kg bw. A comparable LD50 (1800 mg/kg bw) was found for the similar substance.

Acute toxicity-inhalation route

Two studies are available, one with the target substance and one with the similar substance. No guideline was followed in the study on the target substance.

The toxicity of the substance after exposure through the inhalation route was evaluated. Tests were performed using an apparatus for dynamic inhalation; the compound was nebulized in a mixture of water and Lutrol. The animals were held in 2m3 rooms and subjected for 4 hours over half-hour periods to the active ingredient nebulized as a solution in water and Lutrol (1:1). The observation period lasted 14 days. During the Dynamic nebulization inhalation male rats were exposed at 0.143, 0.400, 0.933 mg/l, while female rats were exposed at 0.180, 0.510, 0.940 mg/L. During the static nebulization inhalation, rats were exposed at 0.108, 0.173, 0.864 mg/l. For the dynamic inhalation the LC50 is > 0.933 mg/l for male rats and >0.94 for female rats which correspond to the highest concentration to which the animals were exposed.

The toxicity of the similar substance after exposure through the inhalation route was evaluated instead according to the OECD Guideline 403. 5 male and 5 female Wistar rats were exposed in three different concentrationd of the substance (1.09 mg/l, 3.49 mg/l, 4.76 mg/l) for 4 hours. The LC50 for female and male rats was found as 3.82 mg/l

The study conducted according to the OECD Guideline 403 is used for the chemical safety assessment, as the study on the target substance did not follow any guideline.

Acute toxicity-dermal route

The toxicity of the substance via the dermal route was evaluated considering data on a similar substance. The test item was administered to male and female Vienna white rabbits at dose of 1000, 2000 and 4000 mg/kg bw. LD50 for male/female rabbits was found as 3000 mg/kg.

Justification for classification or non-classification

Based on the available LC50 obtained during the acute toxicity studies and according to the criteria of Annex I: Table 3.1.2 of the CLP Regulation EC No.1272/2008, the substance is classified as follows:

Acute Tox. 4, H302: Harmful if swallowed

Acute Tox. 4, H332: Harmful if inhaled