Registration Dossier

Administrative data

Description of key information

LD50 (oral)> 5000 mg/kg bw (rats)

LD50 (dermal) > 2000 mg/kg bw (rats)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Since no data is available for the evaluation of the acute toxicity of the substance, experimental data on Similar Substance 01 was taken into consideration. Justification for Read Across is given in Section 13 of IUCLID.

Acute oral toxicity

In the Key study, the acute toxic effects of Similar Substance 01 were investigated in a limit test performed in accordance to the OECD Guideline 401. Male and female rats were subjected to a single oral administration of the substance at 5000 mg/kg bw. Rats were observed daily for mortality and clinical signs and were weighed on days 1, 7, 14, and at death. The survived animals were necropsied. No compound related gross organ changes and no significant bodyweight changes were observed. Dyspnoea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6 was observed. The animals recovered within 11 days. LD50 was determined to be> 5000 mg/kg bw.

 

Acute inhalation toxicity

No data is available. Considering exposure conditions, inhalative intake of the substance is low, because of its negligible vapour pressure.

 

Acute dermal toxicity

The acute dermal toxicity of Similar Substance 01 was evaluated according to the OECD Guideline 402. Five male and five female rats were exposed to 2000 mg/kg bw of the substance (at the back) for 24 hours in a semi occlusive coverage. After the exposure period the substance was removed and the animals were observed for 14 days for mortality, signs and symptoms. The survived animals were submitted to a gross necropsy at the end of the observation period. Body weight measurements were done immediately before application and on days 7 and 14. No mortality nor gross pathological changes were noted. No mortality occurred while piloerection, were seen, being common symptoms in acute dermal. Hunched posture, and dyspnoea were also observed. The animals recovered within 2 days. Normal body weight gain was observed. LD50 > 2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data from the acute oral and dermal toxicity studies is used for the assessment of classification of the substance.

LD50 (oral) > 2000 mg/kg bw.

LD50 (dermal) > 2000 mg/kg bw

Based on the available data the substance is not classified as harmful/toxic according to the CLP Regulation (EC) No. 1272/2008.