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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
No data.
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Hydroxylammonium sulphate
IUPAC Name:
Hydroxylammonium sulphate
Test material form:
not specified
Details on test material:
Purity: > 98.4%

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
at a standard dose volume of 5 ml/kg bw
Details on exposure:
No data.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data.
Details on mating procedure:
No data.
Duration of treatment / exposure:
Pregnant rats were treated on day 6 through to day 15 post coitum.
Frequency of treatment:
Daily
Duration of test:
Animals were dosed with the test chemical from day 6 through to day 15 post coitum and sacrificed on day 20.
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 3, 10, 20 mg/kg bw/day
Basis:
nominal in diet
No. of animals per sex per dose:
22 - 24 pregnant female/dose
Control animals:
yes, concurrent vehicle
Details on study design:
No data.

Examinations

Maternal examinations:
Food consumption and body weights of the animals were recorded regularly throughout the study period. Animal health was checked daily.
Ovaries and uterine content:
After sacrifice, the number of corpora lutea, the number and distributions of implantation sites were counted.
Fetal examinations:
No data.
Statistics:
No data.
Indices:
No data.
Historical control data:
No data.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes. Remark: 10 mg/kg bw/day

Details on maternal toxic effects:
An enlargement of the spleen and a dose related statistically significant increase in absolute and relative spleen weights were observed in dams administered the two highest doses of bis(hydroxylammonium) sulfate.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 10 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects. Remark: at highest dose administered (20 mg/kg bw/day)

Details on embryotoxic / teratogenic effects:
There were no substance-related effects on conception rates, the mean number of corpora lutea, implantation sites, pre and post implantation losses, the number of resorptions and of viable foetuses. Examination of foetuses did not reveal any signs for substance related abnormalities.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
At the highest dose (20 mg/kg bw/day) administered to Wistar rats in this study, hydroxylammonium sulphate was not considered to cause embryo/foetotoxicity.
Executive summary:

In a developmental toxicity study according to OECD TG414, hydroxylammonium sulphate was administered to Wistar rats (22 -23/pregnant females/dose) via oral gavage at doses of 1, 3, 10 and 20 mg/kg bw/day on days 6 - 15 post coitum. Animals were sacrificed on day 20 and necropsied. At the two highest doses, dams displayed splenomegaly and a significant increase in absolute and relative spleen weights. No embryo/fetotoxicity was observed at the highest dose administered in this study. A maternal NOAEL of 3 mg/kg bw/day based on effects to the spleen and a NOAEL for embryo/fetotoxicity of 20 mg/kg bw/day can be derived. This study is considered to be reliable, therefore hydroxylammonium sulphate is not considered to be developmental toxicant at concentrations of 20 mg/kg bw/day in rats.