Registration Dossier
Registration Dossier
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EC number: 411-080-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
no data
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
In the subacute study at necropsies organs were weighed and gross pathological investigations performed. A number of organs and tissues were processed histopathologically including ovaries, uterus, vagina, prostate gland, epididymis, testes. No adverse effects were noted from these organs. Based on these results there are no indications for specific adverse effects on the reproductive organs up to 1000 mg/kg bw/day. Due to the lack of adverse effects on reproductive organs up to a dose of 1000 mg/kg bw/day over 28 days, there is no indication of a specific toxic potential to the reproductive organs.
In the reproduction/developmental toxicity screening test in rats the compound did not result in any signs of parental toxicity. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity. In the screening study,1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.
Short description of key information:
For Pigment Yellow FC 26290 a 28-day study is available (see repeated dose toxicity Bomhard/Rosenbruch 1993 ). During the 28-days treatment period male and female Wistar rats received 0, 40, 200 or 1000 mg/kg bw/day Pigment Yellow FC 26290 dissolved in physiological saline by gavage. Reproductive organs of the rats were examined histopathologically.
A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, No. 421 „Reproduction/Developmental Toxicity Screening Test“.
Effects on developmental toxicity
Description of key information
A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, No. 421 „Reproduction/Developmental Toxicity Screening Test“.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
In the reproduction/developmental toxicity screening test in rats the compound did not result in any signs of parental toxicity. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity. In the screening study,1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.
Toxicity to reproduction: other studies
Additional information
no data
Justification for classification or non-classification
There is no evidence for adverse effects on fertility and development. A classification is therefore not justified.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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