Registration Dossier
Registration Dossier
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EC number: 235-008-5 | CAS number: 12054-48-7
Developmental toxicity / teratogenicity
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: Peer reviewed data, acceptable for assessment.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Comments on the draft nickel metal report
- Author:
- NiPERA
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS-Draft
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- IUPAC Name:
- nickel(2+) sulfate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- no data
- Duration of test:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
no data
Basis:
no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 2.2 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Based on the increased postimplantation/perinatal lethality in F1 generation in the OECD TG 416 two-generation study at 2.2 mg Ni/kg bw/day, the NOAEL that is used for developmental toxicity for regulatory purposes is set to 2.2 mg Ni/kg bw/day.
Applicant's summary and conclusion
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