Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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 study available

Additional information

The following data were obtained for Similar Substance 01. It is expected that the Target Substance will have a similar acute oral toxicity profile. Justification for the use of a Read Across approach is provided in Section 13 of IUCLID.

ACUTE ORAL TOXICITY

The acute toxicity was investigated following a single oral administration to the Sprague Dawley rat, followed by a 14-day observation period. The test was performed according to the OECD Guideline 423 (2001). Two groups, each of 3 female animals, were initially dosed at 300 mg/kg. A third group, similarly composed, was dosed at 2000 mg/kg. A fourth group of 3 female animals was administered at the same dose level.

No mortality occurred at any dose levels, excepting one animal found dead on Day 2 of the observation period in the first group dosed at 300 mg /kg. No clinical signs were observed in any dose levels, excepting only black staining on the tail of all animals in the fourth group dosed at 2000 mg/kg was observed for the entire observation period. Body weight changes recorded during the study were within the expected range for this strain and age of animals.

No abnormalities were observed at necropsy examination performed at the end of the observation period on the surviving animals treated at 300 mg/kg and in animals treated at 2000 mg/kg. Only two animals in the fourth group dosed at 2000 mg/kg showed dark staining on the tail. In the early decedent animal consisted in abnormal colour (dark red) of lungs, brain, thymus, heart and thoracic cavity; in addition abnormal content (dark fluid) in the thoracic cavity was recorded.

These results indicate that Similar Substance 01 did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. Similarly, acute oral toxicity tests were performed on Similar Substance 02 and Similar Substance 03, which calculated that the LD50 of Similar Substance 02 was greater than 7760 mg/kg bw, and the LD50 of Similar Substance 03 was greater than 2000 mg/kg bw, when administered to rats by oral gavage. These data support the use of the read-across approach in determining the acute toxicity of the test item.

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) acute toxicity is defined as “those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours”. A substance can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route. The numeric criteria based on the acute toxicity estimates (ATE) in mg/kg bodyweight are presented in Annex I, Part 3, Table 3.1.1. For acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000".

Based on the results of the test performed, the acute toxicity expected (ATE) of the substance was found to be greater than 2000 mg/kg body weight. Therefore, no classification for acute oral toxicity is warranted under the CLP Regulation (EC 1272/2008).