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
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.
