Registration Dossier

Administrative data

Description of key information

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 two studies on acute toxicity after oral application are available for the test substance. These data reveal a very low acute oral toxicity of the test substance: LD50 values in rats are above 2000 mg/kg bw, the upper limit for classification.

In an acute oral toxicity study (Ciba-Geigy Ltd., 1983), groups of 5 male and 5 female Wistar rats were given a single oral dose of the test substance in polyethylene glycol at a dose of 5000 mg/kg bw and observed for 14 days. No animals died and the treated animals showed common symptoms as dyspnoea, exophtalmus, ruffled fur and curved body position. In addition a transient sedation was noted. Therefore the LD50 is greater than 5000 mg/kg bw. In conclusion, according to the test conditions the test substance has practically no acute toxicity when administered orally to the albino rat.

Additionally a supporting study with the test substance is available performed with a much higher concentration (Sythesia, 1989). In this study groups of 5 male and 5 female Wistar rats were given a single oral dose of the test substance in olive oil at a dose of 15850  mg/kg bw and observed for 14 days. No animals died and the treated animals did not show any abnormalities. Therefore the LD50 is greater than 15850 mg/kg bw.

 

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 abstracts 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 these substances are hardly absorbed through the skin. Therefore, no classification for acute dermal toxicity is necessary for the members of the 'yellow disazo condensation pigments'.

 

Inhalation:

In an acute inhalation toxicity study (similar to OECD 403, Ciba-Geigy Ltd., 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 'yellow disazo condensation pigments' have not to be classified for acute toxicity after inhalation exposure.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.