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 several guideline 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 the key study (Ciba-Geigy Ltd., 1980) groups of five rats (Tif : RAIf (SPF)  per sex were administered (by gavage) with 2000, 3000 and 4000 mg test item/kg. The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days was greater than 4000 mg/kg. The treated animals showed common symptoms as dyspnoea, exophtalmus, ruffled fur, curved body position and diarrhoea. In addition a transient sedation was noted. Even in the supporting tests, performed with much higher concentrations (15000 mg/kg and 15850 mg/kg) no animals died during the post observation period.
 
Dermal:
In an dermal toxicity study (Synthesia, 1989) with the test substance, three male Wistar rats were dermally exposed to 5000 mg/kg bw test substance. 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 this study is only short abstract it can be used as supporting study. Furthermore, the substance is also not irritant after skin contact and reveal a low log Pow which indicates that this substance is hardly absorbed through the skin. Therefore, no classification for acute dermal toxicity is necessary for the substance.
 
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 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 ‘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 thirteenth time in Regulation (EC) No. 2018/1480.