Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 234-454-8 | CAS number: 12004-35-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 1998 to December 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific methods. GLP study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Nickel Sulfate Hexahydrate
- IUPAC Name:
- Nickel Sulfate Hexahydrate
- 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 (NiSO4) hexahydrate, 10101-97-0
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Physical state: blue green crystalline powder
- Purity: 99%
- Lot No.: 08516TQ
- Other details not reported or not applicable
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, NY, USA
- Age at study initiation: 11 wks
- Weight at study initiation: 269-360 g (males) and 187-247 g (females)
- Fasting period before study: not reported
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-79 deg F
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 per hour
- Photoperiod (hrs dark / hrs light): 12-h light/dark photoperiod.
IN-LIFE DATES: From: August 4, 1998 To: October 30, 1998
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: reverse osmosis deionized water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was dissolved in reverse osmosis deionized water. Control animals received appropriate volumes of water only. The
homogeneity and stability of the test substance in dosing solutions were determined. The concentration of the test substance in dosing solutions
was analytically confirmed at different time intervals during the study period. Groups of 16 test animals of each parental group (8 males/8
females) received the test substance daily by gavage at the following dosage concentrations: 0, 1.0, 2.0, 3.0, 5.0, and 7.5 mg/ml (equivalent to
dose levels of 0, 10, 20, 30, 50, and 75 mg/kg/day). Dose volume was 10 ml/kg, adjusted for body weight. F0 parental animals received the test substance (or vehicle for control group) daily for 14 days prior to mating and F1 generation on postpartum day 22 and dosing continued until one day
prior to sacrifice. - Details on mating procedure:
- - M/F ratio per cage: Animals were caged as mating pairs (1:1) until copulation was confirmed, then transferred to individual cages.
- Proof of pregnancy: The presence of a vaginal plug or sperm was designated as day 0 of gestation.
- Dams and pups were caged together during lactation. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyzed by AAS
- Duration of treatment / exposure:
- Exposure period: F0: 14 days prior to mating through gestation until postnatal day 21
F1: On lactation day 0 through day 21 - Frequency of treatment:
- daily
- Details on study schedule:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 20, 30, 50, and 75 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 8 males/8 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: selected to produce a graded response
- Rationale for animal assignment (if not random): random - Positive control:
- none reported
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: more detailed clinical observations were made weekly. During gestation and lactation, F0 and F1 females were examined daily for clinical signs of toxicity
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly - Oestrous cyclicity (parental animals):
- Estrous cycle determinations (length and normality) were made daily prior to mating and during cohabitation.
- Sperm parameters (parental animals):
- Sperm was collected from F0 and F1 parental males and examined for sperm count, concentration, motility, and morphology.
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 6 and 13 postpartum
- If yes, maximum of [8] pups/litter ([8]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring: [mortality, general health twice daily]
GROSS EXAMINATION OF DEAD PUPS:
[yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.] - Postmortem examinations (parental animals):
- GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS: not reported - Postmortem examinations (offspring):
- GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS: not reported - Statistics:
- One-way analysis of variance (ANOVA) was used to analyze parental and pup body weight, body weight gain, food consumption, organ weights,
length of gestation and estrous cycle, and litter size. If significance was detected, Dunnett's test was performed to compare control and treatment
groups. Copulation and fertility indices, pup sex ratios, numbers of live and dead pups, and pup survival were evaluated by Chi-Square test.
Post-implantation loss was evaluated using the Mann-Whitney U test. The level of significance was 5% (p<0.05). - Reproductive indices:
- gestation length, litter size, fertility indices
- Offspring viability indices:
- litter size, sex rations, number of live/dead pups
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
Homogeneity and stability of the test substance in gavage dosing solutions was found to be stable for 24 hours at room temperature and up
to 21 days under refrigeration.
F0 generation: No test substance related mortality of clinical signs of toxicity. There were no toxicologically meaningful differences in body weight
gain or food consumption, copulation and fertility indices, gestation length, implantation and post-implantation loss, or sperm parameters.
Post-implantation loss was significantly higher at 30, 50 and 75 mg/kg/day). No treatment related changes found at gross necropsy.
Effect levels (P0)
- Dose descriptor:
- LOAEL
- Effect level:
- 30 other: mg NiSO4/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Mean post-implantation loss was significantly increased at dosage levels >= 30 mg/kg/day.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Litter size was significantly decreased at 10, 20, 30, and 75 mg/kg-day. No significant differences in clinical signs, pup weights, weight gain, or
gross necropsy findings.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- In conclusion, based on the results of this one-generation reproduction range-finding study, dosage levels of 1.0, 2.5, 5.0 and 10.0 mg/kg-day were selected for a definitive two-generation reproductions study in rats.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)