Registration Dossier

Administrative data

Description of key information

Oral: LD50 > 2000 mg/kg bw/day, OECD 401

Dermal: LD50 > 5000 mg/kg bw/day; read across with CAS 5580-57-4 and CAS 5280-80-8

Inhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), similar to OECD 403; read acorss with CAS 5580-57-4

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

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

Acute toxicity: via dermal route

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

Additional information

Oral:

Two studies on acute toxicity after oral application are available for the test substance. In an acute oral toxicity study groups of 20 Tif. RAI rats (10/sex) were given a single dose of the test substance suspended in 30% carboxymethyl-cellulose at doses of 6000 and 7750 mg/kg bw and were observed for 7 days. Within 2 hours after treatment the rats of both dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. The animals recovered within 4 to 6 days. No substance related gross organ changes were seen. The observed LD50 was greater than 7750 mg/kg bw (BASF, 1973).

In a supporting acute oral toxicity study, rats were exposed to a limit concentration of 5000 mg/kg bw of the test substance in arachis oil. Under the conditions of this study an LD50 above 5000 mg/kg bw were observed (Ciba-Geigy Ltd., 1983).

Both studies reveal a very low acute oral toxicity of the pigment with LD50 values in rats above 2000 mg/kg bw, the upper limit for classification.

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. The absence of systemic toxicity upon dermal application is consistent with the lack of systemic toxicity at the limit dose of 2000 mg/kg bw after oral dosing. 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.