Registration Dossier
Registration Dossier
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EC number: 231-298-2 | CAS number: 7487-88-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- other: Published Assessment
- Title:
- SIDS Initial Assessment Profile for SIAM 31: Magnesium sulfate
- Author:
- OECD
- Year:
- 2 010
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Magnesium sulphate
- EC Number:
- 231-298-2
- EC Name:
- Magnesium sulphate
- Cas Number:
- 7487-88-9
- Molecular formula:
- H2O4S.Mg
- IUPAC Name:
- magnesium sulphate
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Males of the main group and both sexes of the recovery group were dosed once daily for a total of six weeks (two weeks each prior to, during and post mating), and females of the main group were dosed once daily for two weeks prior to mating, throughout gestation and for five or six days after delivery.
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 450 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 13
- Control animals:
- yes
Results and discussion
Results of examinations
- Details on results:
- - no deaths in either sex
- no treatment related effects of clinical signs, increased body weight gain, food consumption, haematology, clinical biochemistry, organ weight changes, macroscopical/histopathological findings in males/females at dose levels of 50 and 150 mg/kg bw/day
- soft stool in 450 mg/kg group
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: soft stool
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
