Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-008-5 | CAS number: 12054-48-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- 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:
- Unnamed
- Year:
- 2 002
Materials and methods
- Principles of method if other than guideline:
- see details in remarks o material and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- nickel sulphate hexahydrate
- IUPAC Name:
- nickel sulphate hexahydrate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulphate hexahydrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 75, 100, 125, and 150 mg/kg bw/day. The 125 and 150 mg/kg bw/day doses were reduced to 30 and 15 mg/kg bw/day on day 28 for males only.
Basis:
no data
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: body weight; dose was reduced from 125 mg/kg bw/day at day 28
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
One female rat in the 150 mg NiSO4*6H2O /kg bw/day group was found dead on study day 44, the cause of death could not be established. Clinical observations included post-dosing salivation and decreased activity, most pronounced during the first two weeks and in the highest dose groups. A variety of statistically decreased absolute or increased relative organ weights were noted in the treated rats. These effects were not accompanied by histopathological changes.
The only significant adverse affects seen in this study were weight loss in all dosed groups (8-13% lower body weight compared to controls).
No notable macroscopic or microscopic changes were observed. There was no dose level without effect on body weight, and the LOAEL was thus 7 mg Ni/kg bw/day (30 mg NiSO4*6H2O/kg bw/day (reduced from 125 mg/kg bw/day at day 28)) for males and 11 mg Ni/kg bw/day (50 mg NiSO4*6H2O /kg bw/day) for females.
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.
