Reaction products of diazotized Dodecyl Aniline coupled with 8-acetylamine-1-hydroxynaphthalen-3,6-disulphonic Acid, sodium salts

Endpoint summary

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

ACUTE ORAL TOXICITY

The acute toxicity of test item 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 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. Only violet faeces in cage were observed at 4 hours after dosing in one group at dose 300 mg/kg bw; in the other group at same dose no clinical signs were noted. In one group at dose 2000 mg/kg bw red staining on the tail and on perigenital region in all animals was observed from Day 2 up to Day 15 of the observation period. In the other group at same dose only red staining on the tail in all animals was seen 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 animals of both groups receiving 300 mg/kg and only red staining on the tail was observed in all animals dosed at 2000 mg/kg.

These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg.

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).