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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Study condected according GLP and standard methods
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Aminoiminomethanesulphinic acid was tested for reproduction in a screening test according to OECD 422 and under GLP conditions ( Izumi, 1990). Groups of 12 Crj: CD(SD) rats (m, f) were given 4, 20 and 100 mg/kg bw/day. Male rats were treated with the test material for 49 days. The female animals were exposed from 14 days before mating to day 3 of lactation.

A concurrent negative control group receiving the vehicle (0.5% w/v sodium solution) was included in the testing as well.

With regard to the reproductive performance, decreases in estrus count, numbers of corpora lutea and implantation, and the birth index, as well as extension of the estrous cycle and increased gestation days were observed in females of the 100 mg/kg bw group. No effects related to the test article were observed for the copulation or fertility indices and duration of copulation for males or females. All embryo absorption was observed in three Dams of the 100 mg/kg bw group, and decrease in numbers of newborn, live newborn and the birth index were observed in 100 mg/kg bw group. No effects related to the test article were observed for the sex ratio, newborn body weights and the viability index. There were no external anomalies.

Considering the fact that no abnormalities were found by a gross necropsy and in the following histopathological examination of the reproductive organs of the parental animals, it can be concluded that the negative effects of the high dose of the test item on reproduction were not caused by its toxic properties on those organs directly, but rather on other secondary local or systemic factors affecting parental animal health.

 

Thus, a systemic NOAEL for the parental animals (m, f) of 100 mg/kg bw/day and a NOAEL (m, f) for reproduction of 20 mg/kg bw/day was evaluated in the study.

Short description of key information:

Toxicity to reproduction: NOAEL reproduction (m, f): 100 mg/kg bw (OECD 422, GLP)

Justification for selection of Effect on fertility via oral route:

Study conducted according to GLP and standard method

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

The available data on toxicity to reproduction of aminoiminomethanesulphinic acid (CAS 1758-73-2) do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.

Justification for classification or non-classification