1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxypropyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt (1:6)

Endpoint summary

Description of key information

Category assessment used to read across:
oral: LD50 (rat) > 5000 mg/kg bw/day, OECD 401
dermal: LD50 (rat) > 2000 mg/kg bw/day, OECD 402
inhalation: LC50 (4h, rat) > 1895 mg/m³ air

Additional information

Oral:

Reliable data from several guideline studies on acute toxicity after oral application are available for four members of the stilbene fluorescent whitening agents category (CAS 16090 -02 -1, 13863 -31 -5, 4193 -55 -9, 16470 -24 -9). These data reveal a

very low acute oral toxicity of the stilbene fluorescent whitening agents of this category: LD50 values for all investigated test items in rats are above 2000 mg/kg bw, the upper limit for classification. Even in tests performed with much higher concentrations in the range of 5000 to 15000 mg/kg bw no animals died during the post observation period (except one study where at 15000 mg/kg bw all animals died which lead to a LD50 of 12080 mg/kg bw). Studies with other species (mice, hamster) confirm these findings.

No reliable study on acute oral toxicity of the other category members are available. But due to the consistent observation that the other Stilbene fluorescent withening agents are not toxic after oral administration it is concluded that these members are also not irritating to skin. In summary, no classification for acute oral toxicity is necessary for the members of the stilbene fluorescent whitening agents category then, reading across, also for the substance CAS 371756 -75 -1.

Inhalation:

In acute inhalation toxicity study (similar to OECD 403, Bayer AG 1976), groups of Wistar II rats (10/sex) were exposed to dust of the test substance (CAS 4404 -43 -7) for one and 4 hours and observed for 14 days. No details are reported regarding the particle size distribution of the dust, therefore the study cannot be assigned for validity. No mortality occurred during 14 day observation. At concentrations of 1225 and 1895 mg/m³ air at the 4 hour exposure the animals showed a decreased general condition for about 4 - 6 hours. At autopsy, no deviations from normal morphology were found in all animals. 1895 mg/m³ air was the highest possible concentration. That leads to an LC50 greater than 1895 mg/m³ air at 4 hour exposure. As no lethal effects occurred at the maximum technically feasible concentration it is concluded that the members of the Stilbene fluorescent withening agents category amd then, reading across, also the substance CAS 371756 -75 -1 have not to be classified for acute toxicity after inhalation exposure.

Dermal:

In an acute dermal toxicity study (OECD 402, CIBA-Geigy AG, Switzerland 1990), groups of 10 - 12 week old rats (3/sex) were dermally exposed to undiluted test substance (CAS 16090 -02 -1) for 24 hours to 10% of body surface area at 2000 mg/kg bw. Animals then were observed for 14 days. No mortality occurred. No systemic signs were observed in the animals during the entire observation period. Local symptoms: all animals had a discolored skin (yellow), and 1 male shows scales at the back. All animals had recovered from the local signs after 8 observation days. One female lost slightly weight between day 1 and 8 of the test period. The body weight gain of the further animals was not affected throughout the study by test article treatment. No macroscopical organ findings were observed in the animals.

In another acute dermal toxicity study (Sandoz 1975), groups of rats (5/sex) were dermally exposed to undiluted test substance (CAS 27344- 06 -5) for 24 hours to 10% of body surface area at 5000 mg/kg bw. Animals then were observed for 14 days. No mortality occurred. There were no signs of toxicity. None of the rats showed any observable dermal reactions (including controls). Slightly decreased body weight gains were observed during the first week of treatment, but returned to normal during the second week compared to the controls. Terminal autopsy findings were normal.

In a further acute dermal toxicity study (OECD 402, CIBA-Geigy AG, Basel, Switzerland 1991), groups of 10 - 12 week old rats (5/sex) were dermally exposed to undiluted test substance (CAS 16470 -24 -9)

for 24 hours to 10% of body surface area at 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 were focal erythema found on the back. All animals had recovered from the local signs after 7 observation days. No systemic signs were observed in the animals during the entire observation period. One female slightly lost weight between day 1 and 8 of the test period. The body weight gain of the further animals was not affected throughout the study by test article treatment. No macroscopically organ findings were observed in the animals at terminal necropsy.

Therefore, no classification for acute dermal toxicity is necessary for the members of the Stilbene fluorescent whitening agents category and then, reading across, also for the substance CAS 371756 -75 -1.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for acute oral, dermal or inhalatory toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for acute oral, dermal or inhalatory toxicity under Regulation (EC) No. 1272/2008.