Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

LD50 (male) = 395 mg/kg, equivalent to 177.8 mg/kg a.i..
LD50 (female) = 275 mg/kg, equivalent to 124 mg/kg a.i..

Acute dermal toxicity

LD0 = 2000 mg/kg, equivalent to 1732 mg/kg a.i.

LD50 > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral route

No data on acute oral toxicity was available on target substance. Therefore, available data on Similar Substance 01 and 02, i.e. different salifications of target substance, was used. Details on the read across process are reported in section 13.

Available study with higher reliability was selected as key study and used for decision on classification; supporting studies confirmed such result.

In all studies, rats of both sexes were dosed by gavage and observed for symptoms for 14 days. Based on mortality, LD50 values between 50 and 300 mg/kg were determined.

Clinical symptoms of intoxication, in terms of decreasing general condition, nausea, abdominal / lateral position, sedation, cramps and gasping breathing were seen in all studies. Non-specific damage of the gastrointestinal tract was also seen as main finding in all dead animals upon examinantion.

Tested doses were:

- key study with Similar Substance 01: 200, 350, 500, 1000 mg/kg

- supporting study with Similar Substance 01: 50, 100, 200, 500, 800 mg/kg (M); 50, 100, 200, 250, 310 mg/kg (F)

- supporting study with Similar Substance 02: 100, 160, 200, 225 mg/kg

In the key study, a NOAEL of 200 mg/kg (90 mg/kg a.i.) was established only in male rats. In supporting studies, no clinical symptoms were noted at a dose of 50 mg/kg with Similar Substance 01, i.e NOAEL = 50 mg/kg (28.7 mg/kg a.i.), and at a dose of 100 mg/kg with Similar Substance 02, i.e NOAEL = 100 mg/kg (38 mg/kg a.i.).

Dermal route

Acute dermal toxicity was assessed in male and female rats based on data on target substance. Test substance was applied in semiocclusive way at 1000 and 2000 mg/kg for 24 hours; observation was continued for 14 days. No mortality was seen.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), table 3.1.1, acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

 

For acute toxicity by oral route:

category 1: ATE <= 5 mg/kg bw

category 2: 5 < ATE <= 50 mg/kg bw

category 3: 50 < ATE <= 300 mg/kg bw

category 4: 300 < ATE <= 2000 mg/kg bw

For acute toxicity by dermal route:

category 1: ATE <= 50 mg/kg bw

category 2: 50 < ATE <= 200 mg/kg bw

category 3: 200 < ATE <= 1000 mg/kg bw

category 4: 1000 < ATE <= 2000 mg/kg bw

Based on available information, target substance is classified as Category 3 (H301) for acute oral toxicity, while it is not classified for acute dermal toxicity.