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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
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, disazocondensation red pigments are too large and insoluble for significant systemic uptake. Therefore, no hazard for toxicity to reproduction is expected. The following gives an overview on the available data.

Pigment Red 262 (CAS 79665-24-0, 782 g/mol)

No experimental data available.

 

 

Pigment Red 166 (CAS 3905-19-9, 794.5 g/mol)

No experimental data available. In the subacute oral toxicity study, no adverse effects on reproductive organs were noted (Vuos 2009).

 

 

Pigment Red 144 (CAS 5280-78-4, 829 g/mol)

 

No experimental data available.

 

Pigment Brown 41 (CAS 68516-75-6, 844 g/mol)

 

No experimental data available.

 

 

Pigment Brown 23 (CAS 35869-64-8, 850 g/mol)

 

No experimental data available.

 

 

Pigment Red 214 (CAS 40618-31-3, 863 g/mol)

 

No experimental data available.

 

 

Pigment Red 220 (CAS 68259-05-2, 926 g/mol)

 

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 2012b). Pigment Red 220 (CAS 68259-05-2)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 Red 220 was administered to male rats for 29 days and to female rats for 14 days 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 and development.

All dose-treated males and females had dose-related reddish discolored feces during the treatment period. This finding is considered to be a typical effect resulting from oral administration of a red 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/developmental toxicity was considered to be 1000 mg/kg body weight/day.

 

Pigment Red 221 (CAS 71566-54-6, 926 g/mol)

 

No experimental data available.


Short description of key information:
Disazocondensation red 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 Red 220 (CAS 68259-05-2, BASF 2012).

Justification for selection of Effect on fertility via oral route:
valid study

Effects on developmental toxicity

Description of key information
Disazocondensation red pigments are too large and insoluble for significant systemic uptake. Therefore, no hazard on developmental toxicity is possible. No adverse effects were observed in the screening study at the limit dose (OECD 422) for Pigment Red 220 (CAS 68259-05-2, BASF 2012b).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
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

Pigment Red 220 (CAS 68259-05-2, 926 g/mol)

 A GLP-compliant investigation of the toxicological effects resulting from repeated oral-gavage administration to rats was performed following OECD guideline 422 without deviations (Harlan 2012). Pigment Red 220 (CAS 68259-05-2)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 Red 220 was administered to male rats for 29 days and to female rats for 14 days 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 and development.

All dose-treated males and females had dose-related reddish discolored feces during the treatment period. This finding is considered to be a typical effect resulting from oral administration of a red 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/developmental toxicity was considered to be 1000 mg/kg body weight/day.

 

 

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available screening study in combination with toxicokinetic considerations is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for fertility or developmental toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

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

The available screening study in combination with toxicokinetic considerations is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.