Registration Dossier

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 (sodium salt) was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue (calcium salt) are available. Both substances are salts of sulphonatophenyl-pyrazol-azobenzenesulfonic and differ in their respective cation only. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (a detailed read across justification is given in CSR, Annex I).

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, fertility, gestation and lactation was not influences by the test item. Adecrease of the absolute and relative weight of the prostate gland was recorded in males of all dose levels (dose-independent). Changes did not exceed range of historical control. The histological examination demonstrated the increased occurrence of atrophic changes in prostate gland of males at the dose level 1000 mg/kg/day. This finding was not dose depended and is not considered to be an adverse effect.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 (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. 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 (sodium salt) was not analyzed for its potential to influence reproduction and development. Experimental data of a structural analogue (calcium salt) are available. Both substances are salts of sulphonatophenyl-pyrazol-azobenzenesulfonic acid and differ in their respective cation onlyl. In addition, both substances have a molecular weight higher than 500 g/mol which decreases gastro intestinal absorption and systemic bioavailability (full read across justification in CSR, Annex I).

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

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 thirteenth time inRegulation(EU) 2018/1480.