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Administrative data

Description of key information

Category assessment:
oral: 
subacute (28-days): NOAEL = 1000 mg/kg bw/day (OECD 407) 
subacute (screening): NOAEL = 1000 mg/kg bw/day (OECD 422)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

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

Potential for repeated dose toxicity has been investigated for two disazocondensation yellow pigments.

These represent the one with the lowest molecular weight and the best chance of systemic uptake (Pigment Yellow 155) and one with aromatic amine elements that would be expected to cause adverse effects in case of metabolic degradation (Pigment Yellow 93). Both are considered to be representative for all disazo yellow pigments. All other relevenat parameters such as water and octanol solubility and aromaticity as well as the nature of linkages and hydrolysable groups are basicly identical. A data matrix for both toxicology and physico-chemical endpoints is presented in the toxicokinetics section.

With C. I. Pigment Yellow 93 (CAS number 5580-57-4) a

GLP subacute toxicity study according to OECD TG 407 (Synthesia, 2009) has been performed.

The oral administration of Pigment Yellow 93 to rats (5/sex) by gavage for a period of twenty-eight consecutive days at dose levels 160, 400 and 1000 mg/kg/day produced no toxicologically significant changes in the parameters measured. No major functional changes in any organ systems or severe organ dysfunction were detected. Consistent changes in c1inical biochemistry, haematology and urinalysis parameters, which indicate organ dysfunction, were not recorded at any dose level. Histopathological examination revealed no pathological changes, which could be related with administration of the test substance. Based on the results of laboratory investigations in clinical biochemistry, haematology and urinalysis and with respect to the results of histopathological examination the following conc1usion about NOAEL can be suggested in this study:

The NOAEL (No Observed Adverse Effect Level) for males and females in this study is equal to 1000 mg/kg/day.

A GLP-compliant investigation of the toxicological effects resulting from repeated oral-gavage administration to rats was performed following OECD guideline 422 without deviations with Pigment Yellow 155 (BASF 2013). Pigment Yellow 155 (CAS 68516-73-4) was administered in water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Pigment Yellow 155 was administered to male rats for 41 days and to female rats for 52 days including time prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Treatment with the test item up and including 1000 mg/kg bw/day did not reveal any clinical signs or histological findings and did not affect reproduction.

All dose-treated males and females had dose-related yellow discolored feces during the treatment period. This finding is considered to be a typical effect resulting from oral administration of a yellow dyestuff and not adverse.

Based on these results a general NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg body weight/day.  Therefore, it is concluded that all members of the disazocondensation yellow pigment category are not toxic when administered orally to rat for up 52 days and have not to be classified for repeated oral toxicity.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.