Registration Dossier

Administrative data

Description of key information

Oral: LD50 > 2000 mg/kg bw/day, OECD 423

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), OECD 403; read-across 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
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:

The acute oral toxicity of the test substance in rats was determined in a study according to OECD guideline 423 (Clariant, 1997). The pigment was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed. No mortality occurred. Hunched posture and uncoordinated movements were noted in the majority of animals. The animals had recovered from the symptoms between days 2 and 3, except for one female, which showed hunched posture up to day 4 and on day 12. Yellow staining of the skin by the test substance was noted in all animals between day 3 and 8. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination. The determined LD50 value is above 2000 mg/kg bw, which is the upper limit of 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 theses substance are hardly absorbed through the skin. Therefore, no classification for acute dermal toxicity is necessary for 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.