Registration Dossier
Registration Dossier
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EC number: 235-008-5 | CAS number: 12054-48-7
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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:
- 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
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- 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: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2.2 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: highest dose tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No effects on male sex organs including sperm quality were found in the recent oral OECD TG 416 two-generation study and the NOAEL is therefore the highest dose studied, i.e. is 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.
