Registration Dossier

Administrative data

Description of key information

Category assessment:
Oral: LD50 > 2000 mg/kg bw/day, OECD 401
Dermal: LD50 > 5000 mg/kg bw/day
Inhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), OECD 403

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
1 700 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

Additional information

Oral:

Reliable data from several guideline studies on acute toxicity after oral application are available for four members of disazocondensation yellow pigments category (CAS 5580-57-4, 5280-80-8, 68516-73-4, 79953-85-8). These data reveal a very low acute oral toxicity of the disazocondensation yellow pigments 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. The treated animals showed common symptoms as dyspnoea, exophtalmus, ruffled fur, curved body position and diarrhoea. In addition a transient sedation was noted.

No reliable study on acute oral toxicity of one category member (CAS 5580-58-5) is available. But due to the consistent observation that the other disazocondensation yellow pigments are not toxic after oral administration it is concluded that this member is also not acute toxic after oral exposure. In summary, no classification for acute oral toxicity is necessary for the members of the disazocondensation yellow pigments category.

 

Dermal:

In two acute dermal toxicity studies (Synthesia, 1989), three male Wistar rats were dermally exposed to 5000 mg/kg bw test substance (CAS 5580-57-4 and 5280-80-8). Animals then were observed for 14 days. No mortality occurred. No systemic signs were observed in the animals during the entire observation period. No macroscopical organ findings were observed in the animals.

Although these studies are only short abstract they can be used as weight of evidence since they show both the same results. Furthermore, the substances are also not irritant after skin contact and reveal a low log Pow which indicates that theses substance are hardly absorbed through the skin. Therefore, no classification for acute dermal toxicity is necessary for the members of the disazocondensation yellow pigments category.

 

Inhalation:

In an acute inhalation toxicity study (similar to OECD 403, Ciba-Geigy, 1976), groups of Tif:RAIf rats (9/sex) were exposed to dust of the test substance (CAS 5580-57-4) for 4 hours and observed for 14 days. No mortality occurred during 14 day observation. At concentrations of 1700 mg/m³ air at the 4 hour exposure the animals showed no toxic symptoms. At autopsy, no deviations from normal morphology were found in all animals. 1700 mg/m³ air was the highest possible concentration. That leads to an LC50 greater than 1700 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 disazocondensation yellow pigments category have not to be classified for acute toxicity after inhalation exposure.

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 substance is not considered to be classified for acute 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 substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.