Registration Dossier
Registration Dossier
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EC number: 416-730-1 | CAS number: 154946-66-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
Read across justification
The test item (diammonium salt) was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue (calcium-salt) are available. The substances are salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid and differ in their respective inorganic cation only. A detailed read across justification is given in Annex I of the chemical safety report.
Procedure and observations
A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The analogue substance was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation.
The test material did not influence fertility or reproduction of the test animals. Atrophic changes in prostate gland of parental males of the high dose group were observed. This effect did not negatively influence fertility of parental males and is not considered as adverse effect.
Discussion
Administration of an analogue test substance up to 1000 mg/kg bw did not induce mortalities, clinical signs or changes in body weight or food consumption. Mating behaviour, fertillity, gestation and laction was not influences by the test item. Therefore, the test material is not considered to as toxic to reproduction.
Short description of key information:
Experimental data of a read across substance (calcium salt) are used to evaluate the reprotoxic potential of the test item. A screening assay was conducted to determine toxicity to reproduction and development (OECD guideline 421, GLP). The structural analogue did not influence fertility of parental animals or development of the offspring. The NOAEL for fertility was considered to be 1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
Experimental data of a read across substance (ammonium salt) are used to evaluate the reprotoxic potential of the test item. A screening assay was conducted to determine toxicity to reproduction and development (OECD guideline 421, GLP). The structural analogue did not influence fertility of parental animals or development of the offspring. Teratorgenicity or malformations were not observed. The NOAEL for developmental toxicity is considered to be 1000 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
Read across justification
The test item (diammonium salt) was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue (calcium-salt) are available. The substances are salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid and differ in their respective inorganic cation only. A detailed read across justification is given in Annex I of the chemical safety report.
Procedure and observations
A Reproduction / Developmental Toxicity screen was conducted to determine possible influence on fertility and teratogenicity. The test item was administered by gavage at concentrations of 0,160, 400 and 1000 mg/kg bw/day to male and female Wistar rats (12/sex/dose). Males were treated totally for 28d, females were treated until 3rd day of lactation. As a result, the ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.Discussion
Administration of the analogue substance did not affect number, viability and development of the offsping, also teratogenicity was not observed. Thus, the substance is not considered to own developmental toxicity.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for reproductive toxicity under Directive 67 / 548 / EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, 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 reproductive toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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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