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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
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Valid
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Pigment Red 177 was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 100, 300 and 1000 mg/kg bw/d. The study followed OECD testing guideline 422 and GLP (BASF 2013). The test substance was suspended in water as it is not soluble in any vehicle.

Regarding clinical examinations,signs of general systemic toxicity were not observed in male and female parental animals of test groups 1-3 (100, 300 and 1000 mg/kg bw/d) during the entire study period. Female animal No. 138 of test group 3 (1000 mg/kg bw/d) showed clinical findings during lactation and did not properly nurse its pups on postnatal day (PND) 0 and 1. Taking into account that the litter size of 17 pups was very high for this rat strain, giving birth to this high amount of pups was considered to have been exhausting and stressful for the animal. The resulting impaired clinical condition of the animal during lactation was assessed to have been influenced the nursery and, given that, led to the increased pup mortality. In addition, the increased occurrence of runts on PND 1 was assumed as being related to the litter size which has been proven to have an impact on the development status of pups (Romero et al., 1992). Therefore, the occurrence of the mentioned findings in the single animal was not assessed as being related to treatment. Fertility indices for male and female animals were not impaired by test-substance administration even at a dose level of 1000 mg/kg bw/d. In addition, live birth indices of pups in all test groups were not influenced.

Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose of the compound of 1000 mg/kg bw/d. Regarding pathology, there were no treatment-related organ weight changes. Histopathology revealed the presence of the test substance in the lumen of the gastrointestinal tract in form of red particles or crystals. This correlated with the red discoloration of the contents observed macroscopically. This finding did not cause any tissue alterations and therefore it was considered to be treatment-related but not adverse.

As discussed in the toxicokinetics section, the pigment is considered to be not taken up by the body by the oral route.


Short description of key information:
No adverse effects on fertility were observed in a screening study in rats (OECD 422, BASF 2013). The highest tested dose was 1000 mg/kg bw.

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

Effects on developmental toxicity

Description of key information
No adverse findings on offspring were observed in a screening study for developmental toxicity in rats with doses of up to 100, 300 and 1000 mg/kg bw (OECD 422, GLP) (BASF 2013).
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

The study is discussed in the section for fertility and repeated dose toxicity.

The viability index as indicator for pup mortality was not impaired by test-substance administration at a dose level of 1000 mg/kg bw/d. The postimplantation loss was comparable for all dose groups. No adverse effects on offspring were observed.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available screening study 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 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).

During the four days covered in the screening study, no effects via lactation were observed.

Additional information