[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate

Endpoint summary

Description of key information

In an acute oral toxicity study (equivalent to OECD 401), groups of young Wistar rats (5/sex/dose) were given a single oral dose of a liquid mixture containing the target substance (57.2 %) at doses of 2.0, 3.1, 3.5, 4.0, 5.0 and 6.3 mL/kg bw and were observed for 14 days. Mortality occurred during the first 3 days after application. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection, and apathy. Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects. Based on the results, the combined oral LD₅₀ was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL).

The acute toxicity of Basic Red 18:1 Chloride was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg body weight was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination. No mortality occurred and only red staining at the treated site, due to the colour of the test substance, was observed in all male and female animals from Day 2 up to the end of the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. Only red staining at the treatment site, due to the colour of the test substance, was found at necropsy in all animals at termination of the study. These results indicate that the test item, Basic Red 18:1 Chloride, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the LD₅₀to be greater than 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 370 mg/kg bw

Quality of whole database:

Study conducted equivalent to OECD TG 401

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

Quality of whole database:

Guideline study

Justification for classification or non-classification

The oral LD₅₀ value was determined with 4370 mg/kg bw. By extrapolating the concentration of 57.2% of the target substance within the mixture to 100% the calculated LD₅₀ value would be 2500 mg/kg bw. This approach is in line with recommendations of the CLP Regulation (EC) No 1272/2008.

No data on acute dermal toxicity is available for the target substance. Thus, available data from the source substance was used in a read-across approach. Details on the read-across rational are provided in section 13. The dermal LD50 value of the source substance was determined with greater than 2000 mg/kg bw due to the lack of mortality.

Based on the available data, the test item does not warrant classification for acute toxicity.