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Registration Dossier
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EC number: 226-970-7 | CAS number: 5580-57-4
Endpoint summary
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 of 1000 mg/kg bw/d (OECD 421, GLP).
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
A screening study for reproductive and developmental toxicity was conducted according to OECD guideline 421 and GLP. The effects of the test item on male and female reproductive performance, such as gonadal function, mating behaviour, conception, development of conceptuses, parturition and lactation of the offspring were investigated, upon daily administration of the test item by oral gavage toWistar Hannover rats.
Males were treated 14 days before pairing, trough the pairing period and up to one day before sacrifice for a total of 34/35 days. Femaleswere treated 14 days before pairing, trough pairing and gestation periods, and during post partum phase until Day 13 or the day before sacrifice (for a maximum of 66 days of treatment).
The doses used were: 0, 100, 300 and 1000 mg/kg/day and were administered at a dose volume of 10 mL/kg body weight. The control group received the vehicle alone (0.5% carboxymethyl cellulose).
The following investigations were performed on parental animals: mortality, clinical signs, body weight, body weight gain, food consumption, oestrous cycle, mating performance, litter data, sex ratios, thyroid hormones determination (parental males), macroscopic observations and organ weights. Histopathological evaluation was performed on all males and females from control and high dose groups and on the abnormalities detected during post mortem examination. The identification of the stages of the spermatogenic cycle was also performed from all males in the control and high dose groups. Clinical signs, measurement of anogenital distance, post mortem external and/or internal examination were recorded for pups. Thyroid hormone levels were also determined in 1 pup/sex/group randomly selected at Day 14 post partum.
During the study, no mortality or other adverse effects concerning systemic toxicity, reproductive performance or development could be observed.
On the basis of the results obtained, no changes that could be clearly attributable to the treatment with the test item were observed at any dose level investigated. Therefore, the NOAEL (No Observed Adverse Effect Level) for general toxicity, reproductive and developmental toxicity was considered to be 1000 mg/kg/day, for male and female parental animals and pups.
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 of 1000 mg/kg bw/d (OECD 421, GLP).
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
A screening study for reproductive and developmental toxicity was conducted according to OECD guideline 421 and GLP. The effects of the test item on male and female reproductive performance, such as gonadal function, mating behaviour, conception, development of conceptuses, parturition and lactation of the offspring were investigated, upon daily administration of the test item by oral gavage toWistar Hannover rats.
Males were treated 14 days before pairing, trough the pairing period and up to one day before sacrifice for a total of 34/35 days. Femaleswere treated 14 days before pairing, trough pairing and gestation periods, and during post partum phase until Day 13 or the day before sacrifice (for a maximum of 66 days of treatment).
The doses used were: 0, 100, 300 and 1000 mg/kg/day and were administered at a dose volume of 10 mL/kg body weight. The control group received the vehicle alone (0.5% carboxymethyl cellulose).
The following investigations were performed on parental animals: mortality, clinical signs, body weight, body weight gain, food consumption, oestrous cycle, mating performance, litter data, sex ratios, thyroid hormones determination (parental males), macroscopic observations and organ weights. Histopathological evaluation was performed on all males and females from control and high dose groups and on the abnormalities detected during post mortem examination. The identification of the stages of the spermatogenic cycle was also performed from all males in the control and high dose groups. Clinical signs, measurement of anogenital distance, post mortem external and/or internal examination were recorded for pups. Thyroid hormone levels were also determined in 1 pup/sex/group randomly selected at Day 14 post partum.
During the study, no mortality or other adverse effects concerning systemic toxicity, reproductive performance or development could be observed.
On the basis of the results obtained, no changes that could be clearly attributable to the treatment with the test item were observed at any dose level investigated. Therefore, the NOAEL (No Observed Adverse Effect Level) for general toxicity, reproductive and developmental toxicity was considered to be 1000 mg/kg/day, for male and female parental animals and pups.
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 (EC) No 1272/2008. Based on results of a screenig study for reproductive and developmental toxicity (OECD 421), the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
Additional information
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