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Administrative data

Description of key information

An oral LD50 of greater than 2000 mg/kg bw was determined and no mortality was observed in an acute oral toxicity study in rats (GLP, OECD 423, 2000).
A dermal LD50 of greater than 2000 mg/kg bw was determined and no mortality was observed in an acute dermal toxicity study with rats (GLP, OECD 402, 2012).

No mortality was observed after a 4h-exposure (including a 14 -day recovery period) to a dust aerosol (4250 mg/m3) of a related pigment (similar to OECD 403, performed in 1978).

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
Quality of whole database:
Well documented study report.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
4 250 mg/m³

Acute toxicity: via dermal route

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

Additional information

Acute oral toxicity

In an acute oral toxicity study according to OECD guideline 401, groups (5/sex) of Sprague Dawley rats (5 weeks old) were given a single oral dose of the test item in corn oil at doses of 0 and 2000 mg/kg bw. Animals were then observed for 14 days.

No mortality was observed. Animals did not exhibit any signs of systemic toxicity and showed expected gains in body weight over the study period. No gross internal lesions were detected during necropsy. Discharge of feces in the same orange color as the test substance was observed approximately 5 hours after administration for 1 male and on day 2 of observation for all males and females. However, no noteworthy changes were found in general condition of the animals.

The acute dermal median lethal dose (LD50) of the test item in the Sprague-Dawley rat was found to be greater than 2000 mg/kg bodyweight.

Acute dermal toxicity

In an acute dermal toxicity study according to OECD guideline 402, a group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

No mortality was observed. Animals did not exhibit any signs of systemic toxicity and showed expected gains in body weight over the study period. No gross internal lesions were detected during necropsy.

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Acute inhalation toxicity

Male and female rats were exposed for 4h to a dust aerosol in a nose-only setting to a related pigment (Pigment Yellow 13). After the exposure, rats were observed for 14 days and then subjected to necropsy. The study was performed in 178, but is well reported and the procedure is the one later described in OECD TG 403. In the study report, the particle size was not reported; it is however reported in the follow-up 3 -week-inhalation study. 70 -80% of the particles had a diameter of less than 7 micrometer. No mortality was observed.


Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality was observed at the limit dose of 2000 mg/kg bw for both the oral and the dermal route. No mortality was observed for a related substance at the limit dose of 4250 mg/m3. As a result the substance does not need to be classified and labelled for acute toxicity (oral, dermal, inhalation) under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 1221/2015.