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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-standard screening test.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Principles of method if other than guideline:
No guideline study.
As part of a validation of a developmental screen, pregnant mice were exposed to 55 compounds, composed of known teratogens, known non-teratogens or equivocal substances.
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium sulphate
EC Number:
231-820-9
EC Name:
Sodium sulphate
Cas Number:
7757-82-6
Molecular formula:
Na2SO4
IUPAC Name:
disodium sulfate
Details on test material:
Na2SO4, not specified

Test animals

Species:
mouse
Strain:
other: ICR/SIM

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Single daily dose by gavage; dose level at or near induction of maternal toxicity.
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
No data.
Duration of treatment / exposure:
4 days (gestation day 8-12)
Frequency of treatment:
Once daily
Duration of test:
Up to day 22 of pregnancy
Doses / concentrations
Remarks:
Doses / Concentrations:
2800 mg/kg/day
Basis:
actual ingested
test material
No. of animals per sex per dose:
28-30
Control animals:
other: yes (N=28, vehicle alone H2O)

Examinations

Maternal examinations:
Maternal weight gain, delivery rate, litter size, % live births, pup weight on day 1 and day 3 were examined.
Fetal examinations:
Neonatal survival rate, macroscopic visceral and skeletal abnormalities were examined.
Statistics:
Maternal weight: two-tailed analysis of variance live and dead litter size: one-tailed analysis of variance neonatal survival rate: Fisher one-tailed exact probability.
Neonatal weight: two-tailed analysis of variance with litter size as co-variant.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
Normal maternal weight gain, normal delivery rate, normal litter size, normal nr. of live births.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
2 800 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Compared to controls, slight increase in neonatal body weight at day 1 p.p. (1.80+0.14 vs 1.72 + 0.13 grams). Normal weight of pups on day 3, no macroscopic visceral or sceletal abnormalities.

The slight increase in body weight of neonates on day 1 p.p. only is not an adverse effect and is biologically totally irrelevant.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
2 800 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: developmental toxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL (mouse, oral) maternal toxicity = 2800 mg test material/kg bw/ day
NOAEL (mouse, oral) developmental toxicity = 2800 mg test material/kg/bw/ day

Normal maternal weight gain, normal delivery rate, normal litter size, normal nr. of live births.
Compared to controls, slight increase in neonatal body weight at day 1 p.p. (1.80+0.14 vs 1.72 + 0.13 grams). Normal weight of pups on day 3, no macroscopic visceral or sceletal abnormalities.
The slight increase in body weight of neonates on day 1 p.p. only is not an adverse effect and is biologically totally irrelevant.
Executive summary:

Seidenberg et al.,1986 examined the developmental effects of sodium sulfate in the mouse as part of a validation effort of a developmental screening test. The test substance was administered (2800 mg/kg/day) by gavage on gestation days 8 through 12. No mortality, an unchanged average weight gain, and normal number of litters and neonates/litter were found. A 100 % perinatal survival was found, with an increased postnatal weight at day 1, normal weight at day 3 in the absence of externally visible abnormalities. In second paper of Seidenberg et al, 1987 the results are summarised of this validation test, the outcome of the screening test was consideredpositive for sodium sulfate, based solely on the increased postnatal weight on day 1 post-partum. However, the significance of such an effect, in the absence of any other effect, is unclear and the reasons for taking this as a positive result are not given.