4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bisarenoate sodium salt

Endpoint summary

Description of key information

Oral (similar to OECD 401), rat: LD 50 > 5000 mg/kg bw (limit test); RA from CAS 16470-24-9
Dermal (OECD 402), rat: LD 50 > 2000 mg/kg bw (limit test); RA from CAS 16470-24

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

There is no data available on acute toxicity of the test substance. However, reliable data from an acute toxicity studies performed with CAS 16470-24-9; a close structural analogue, is available.

 

Acute oral toxicity:

In an acute oral toxicity study (similar to OECD 401) performed with CAS 16470-24-9 (> 80% pure), 5 rats (Tif:RAif) per sex were administered the test substance per gavage at the limit dose of 5000 mg/kg bw. Polyethylene glycol was used as vehicle. No mortality occurred during the observation period of 14 days. Clinical signs like dyspnoea, exophthalmos, ruffled fur, diarrhea and curved body position were observed until day 8, 3, 7, 1 and 6, respectively.

Thus, based on the LD50 > 5000, classification for acute oral toxicity is not warranted (CIBA-GEIGY Ltd., 1981).

 

Acute inhalative toxicity:

Inhalation of the pure substance is not considered to be a significant route of exposure.

According to Regulation (EC) 1907/2006, Annex VIII, Column 2, 8.5.2, an acute inhalation toxicity study is, therefore, not required.

Acute dermal toxicity:

In an acute dermal toxicity study (OECD 402), groups of 10 - 12 week old rats (5/sex) were dermally exposed to the undiluted test substance (CAS 16470-24-9; 88.1% pure) for 24 hours to 10% of body surface area at the limit dose of 2000 mg/kg bw. Animals then were observed for 14 days. No mortality occurred and normal body weight gains were found in this study. The following local signs were observed: at 2000 mg/kg all males and females showed scales at the back. General erythema at the back was found in 3 animals. Only in 3 males focal erythema were found on the back. These local findings were fully reversible within 7 days in all animals. No systemic signs were observed in the animals during the entire observation period. One female slightly lost weight between day 1 and 8; the body weight gain of the other animals was in the normal range throughout the study. No macroscopical organ findings were observed in the animals at terminal necropsy. Thus, based on the LD50 > 2000 mg/kg, classification for acute dermal toxicity is not warranted (CIBA-GEIGY Ltd., 1991).

Justification for classification or non-classification

The available data on acute toxicity is reliable and suitable for classification. Based on this data, classification for acute toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.