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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

'Yellow disazo condensation pigments' are too large and insoluble for significant systemic uptake. Therefore, no hazard for toxicity to reproduction is possible. No adverse effects were observed in the screening study at the limit dose (OECD 422) for Pigment Yellow 155 (CAS 68516-73-4, BASF 2012).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

As discussed in the section of toxicokinetics, 'yellow disazo condensation pigments' are too large and insoluble for significant systemic uptake. Therefore, no hazard for toxicity to reproduction is expected. This was shown for one member of the 'yellow disazo condensation pigments' with the lowest molecular weight (CAS 68516-73-4):

A GLP-compliant investigation of the toxicological effects resulting from repeated oral-gavage administration to rats was performed following OECD guideline 422 without deviations (BASF, 2012). 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.

The NOEL (No Observed Effect Level) for reproduction toxicity was considered to be 1000 mg/kg body weight/day.

Effects on developmental toxicity

Description of key information

'Yellow disazo condensation pigments' are too large and insoluble for significant systemic uptake. Therefore, no hazard for toxicity to reproduction is possible. No adverse effects were observed in the screening study at the limit dose (OECD 422) for Pigment Yellow 155 (CAS 68516-73-4, BASF 2012).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

As discussed in the section of toxicokinetics, 'yellow disazo condensation pigments' are too large and insoluble for significant systemic uptake. Therefore, no hazard for toxicity to reproduction is expected. This was shown for the one member of 'yellow disazo condensation pigments' with the lowest molecular weight (Pigment Yellow 155, CAS 68516-73-4):

A GLP-compliant investigation of the toxicological effects resulting from repeated oral-gavage administration to rats was performed following OECD guideline 422 without deviations (BASF 2012). 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 development of F1 generation.

All dose-treated males and females had dose-related yellowish 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.

The NOEL (No Observed Effect Level) for developmental toxicity was considered to be 1000 mg/kg body weight/day.

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 1272/2008. As a result the substance is not considered to be classified for toxicity to reproduction under Regulation (EC) No. 1272/2008 as amended for the third time in Directive EC 618/2012.