Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Sulfates up to and including 3320 ppm in water have no significant effect on reproduction in the gilt or sow.

Effect on fertility: via oral route

Dose descriptor:

NOAEL

790 mg/kg bw/day

Additional information

In a OECD guideline combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (NIER 2002), calcium sulfate, dihydrate was administered by gavage at the dose levels of 0, 100, 300 and 1,000 mg/kg bw/day for more than 35 days and 41~45 days for male and female rats respectively and the pre-mating exposure period was 14 days. No adverse effects were observed in terms of fertility, delivery and nursing in parent animals during the test period. There were no signs of reproduction/developmental toxicity on the body weight gestation index, sex ratio, clinical signs or viability up to 1,000 mg/kg/day (highest dose tested). According to the result of reproductive toxicity screening test, the NOAEL for calcium sulfate dihydrate was the highest dose tested (1000 mg/kg day) which equates to 790 mg/kg bw day for calcium sulfate anhydrous.

Short description of key information:
Data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13).
Calcium sulfate dihydrate showed no signs of reproduction/developmental toxicity in an OECD 422 reproduction/developmental screening test.

Effects on developmental toxicity

Description of key information

Calcium sulfate had no effects on nidation or on maternal or foetal survival in mice,rats and rabbits at doses up to 1600 mg/kg bw. 

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 600 mg/kg bw/day

Additional information

In a guideline equivalent teratology study (Morgareidge 1974) mice, rats and rabbits were dosed by oral gavage with calcium sulfate up to 1600 mg/kg. Body weights of live pups were recorded and all foetuses were examined for the presence of external congenital abnormalities. One third of the foetuses for each litter underwent detailed visceral examinations T

Administration of up to 1600 mg/kg bw of calcium sulfate to pregnant mice for 10 consecutive days had no clearly discernable effects on nidation or on maternal or foetal survival.

Administration of up to 1600 mg/kg bw of calcium sulfate to pregnant rats for 10 consecutive days had no clearly discernable effects on nidation or on maternal or foetal survival.

Rabbits: up to 1600 mg/kg bw of calcium sulfate to pregnant rabbits for 13 consecutive days had no clearly discernable effects on nidation or on maternal or foetal survival.

Toxicity to reproduction: other studies

Additional information

In a study cited in the available literature (Paterson et al 1979) A reproductive trial involved 31 sows and 27 gilts of Hampshire x Yorkshire x Duroc breeding. Sows and gilts were grouped separately on the basis of ancestry and weight. Outcome groups were randomly assigned to the three treatments. The three treatments consisted of sodium sulfate added to water to give sulfate and total dissolved solids in ppm as follows (1): 320, 620, (2) 1820, 2840 and (3) 3320, 5060.

There were no significant differences in gestation or lactation gains and number or weight of pigs at birth or at weaning. Fecal consistency was normal in all treatments. Water consumption did not differ during gestation but increased during lactation as salt level increased. These results suggest that sulfates up to and including 3320 ppm in water have no significant effect on reproduction in the gilt or sow.

Justification for classification or non-classification

Calcium sulfate is not toxic to reproduction and has no effect on fertility or development. Consequently, it does not warrant classification under DSD or CLP. This accounts for Ettringite as well.