Registration Dossier

Diss Factsheets

Administrative data

Description of key information

NOAEL = 500 mg/kg bw/d

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Study well conducted and well detailed.
System:
haematopoietic
Organ:
liver

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A 90 -days study in rats of both sexes was available. Rats were divided in groups of 4 animals/sex and dosed in diet at levels of 0, 0.5, 1 and 2 %. Body weight and food intake were recorded weekly. Blood parameters, serum chemistry, urine, organ weights and histological findings were also examined.

Treatment related effects were reported in the 2 % group. In particular:

- on blood parameters: decrease of red cells count and haematocrit as well as statistically significant decrease of haemoglobin;

- on serum chemistry: increase in transaminase levels, possibly indicative of liver injury.

On these bases: NOAEL = 500 mg/kg bw/d (1 % group); LOAEL = ca. 1000 mg/kg bw/d (2 % group).

It should be noted that such study was also used by the Scientific committee on cosmetic products and non-food products (SCCNFP/0792/04) in the assessment on the substance.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), classification in category 1 for repeated dose toxicity applies to substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure. Substances are classified in category 1 for target organ toxicity (repeat exposure) on the basis of:

— reliable and good quality evidence from human cases or epidemiological studies; or

— observations from appropriate studies in experimental animals in which significant and/or severe toxic effects, of relevance to human health, were produced at generally low exposure concentrations.

As for classification in category 2, it applies to substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure. Substances are classified in category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations.

For studies of 90-day duration, classification in category 1 applies when toxicity by oral route is seen at concentrations below 10 mg/kg/d, while category 2 applies for toxicity at doses between 10 and 100 mg/kg/d.

Based on available data of a no-observed adverse effect level of 500 mg/kg bw/d, Acid Red 018 was found as non fulfilling the criteria for classification after repeated exposure by oral route according to the CLP Regulation (EC 1272/2008).