Sodium sulphamidate

Endpoint summary

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

The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and was designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test” (adopted 22 March 1996).

There were no treatment-related effects detected in the reproductive parameters observed.

Reproductive Performance:

Mating.

There were no treatment-related effects on mating for treated animals.

Fertility.

There were no treatment-related effects on conception rates for treated animals.

Gestation Lengths.

There were no differences in gestation lengths. The distribution for treated females was comparable to controls.

Short description of key information:
The oral administration of Sodium sulphamate to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day.

No treatment related effects were detected in the reproductive parameters examined therefore the ‘No Observed Effect Level’ (NOEL) for reproductive/developmental toxicity was considered to be 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

The oral administration of Sodium sulphamate to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects.  The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day.
No treatment related effects were detected in the reproductive parameters examined therefore the ‘No Observed Effect Level’ (NOEL) for reproductive/developmental toxicity was 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

There were no treatment-related effects detected in the reproductive parameters observed.

Litter Responses:

Offspring Litter Size, Sex Ratio and Viability.

Of the litters born, litter size at birth and subsequently on Days 1 and 4 post partum were comparable to controls. There were no intergroup differences in sex ratio.

Offspring Growth and Development.

Offspring body weight gain and litter weights at birth and subsequently on Days 1 and 4 post partum were comparable to controls. No effect on surface righting reflex was detected. 

Offspring Observations.

No clinically observable signs of toxicity were detected for offspring from all treatment groups.

Justification for classification or non-classification

The oral administration of Sodium sulphamate to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day.

No treatment related effects were detected in the reproductive parameters examined therefore the ‘No Observed Effect Level’ (NOEL) for reproductive/developmental toxicity was considered to be 1000 mg/kg bw/day.

The OECD 422 Combined Repeat Dose Toxicity with Reproduction/Developmental Toxicity Screening Test showed no treatment related effects in the reproductive parameters examined at any dose level. Therefore, there is no evidence that the substance has an adverse effect on sexual function and fertility, or on development. The substance is therefore not classified for reproductive toxicity based on this study.