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Diss Factsheets
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EC number: 232-104-9 | CAS number: 7786-81-4
- 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)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryotoxic and Teratogenic Effects of Nickel in Swiss Albino Mice during Organogenetic Period
- Author:
- Saini S, Nair N, Saini MR.
- Year:
- 2 013
- Bibliographic source:
- BioMed Research International Volume 2013, Article ID 701439, 9 pages
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ni was administered orally on body weight base durign the organogenesis period from days 6 to 13 of gestation period and developmental endpoints were assessed on gestnational day 18.
- GLP compliance:
- not specified
- Remarks:
- GLP compliance not specified in manuscript
- Limit test:
- no
Test material
- Reference substance name:
- Nickel dichloride
- EC Number:
- 231-743-0
- EC Name:
- Nickel dichloride
- Cas Number:
- 7718-54-9
- Molecular formula:
- Cl2Ni
- IUPAC Name:
- Nickel (II) chloride
- Reference substance name:
- Nickel chloride
- EC Number:
- 253-399-0
- EC Name:
- Nickel chloride
- Cas Number:
- 37211-05-5
- IUPAC Name:
- nickel(2+) dichloride
- Details on test material:
- Nickel chloride hexahydrate procured fromHi-Media Laboratories Pvt. Ltd., Mumbai, (Purity: 97.0%) was used for the study.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Details on test animals or test system and environmental conditions:
- Swiss albino mice (7–9 weeks of age, 24 ± 2 gm) selected from an inbred colony were maintained on standard mice feed (Aashirwad Ltd., Chandigarh) and tap water ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Animals were divided into four groups of ten mice each. Group I was given tap water and served as a control, while groups II, III, and IV were given 46.125, 92.25, and 184.5mgNi/kg b.wt. as NiCl2 ⋅6H2O orally from days 6 to 13 of gestation, that is, organogenetic period. The doses were selected below LD50, that is, 369mgNi/kg b.wt. Dams were sacrificed by cervical dislocation on day 18 of gestation, and uteri of all the sacrificed dams were examined.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Female and male mice were housed formating in the ratio of 3 : 1 and examined every morning for vaginal plug. The day on which vaginal plug were detected was considered as day zero of pregnancy.
- Duration of treatment / exposure:
- From days 6 to 13 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- Until gestational day 18.
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Diet consumption, water intake and body weight of all the groups were recorded daily.
- Ovaries and uterine content:
- The uteri of all the sacrificed dams were examined.
- Fetal examinations:
- The implant sites and live fetuses per dam were counted, and the conceptus at each site was classified as being alive, resorbed, or dead. The live fetuses were sexed, weighed, and examined for morphological alterations. Randomly selected 75% of fetuses were fixed in 95% alcohol for double staining (alizarin red S and alcian blue) to observe the skeletal anomalies, and the remaining fetuses were fixed in Bouin’s fixative to study the brain.
- Statistics:
- Thestatistical analysis of the data was evaluated by using the Microsoft Office Excel 2003 software, and the significance of the data was determined either by using one way analysis of variance (ANOVA) or one way Mann-Whitney U test. The levels of significance were p < 0.05 (almost significant) and p < 0.01 (significant).
- Indices:
- Average number of implant sites/dam, Average number of live fetuses/dam
- Historical control data:
- None reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The pregnant females administered with Ni+2 during organogenetic period revealed an almost significant (p < 0.05) decrease in diet consumption after 92.25 mgNi/kg b.wt. However, after 184.5 mgNi/kg b.wt., the decrease was significant (p < 0.01). Similar pattern of decrease was evident in intake of water. Maternal weight decreased significantly (p < 0.01) after 92.25 and 184.5 mgNi/kg b.wt.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 184.5 mg/kg bw/day (nominal)
- Based on:
- element
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 92.25 mg/kg bw/day (nominal)
- Based on:
- element
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The average implant sites per dam decreased after 92.25 and 184.5 mg Ni/kg b.wt. when compared with the control group. Average number of live fetuses/dam were significantly reduced (p < 0.01) in group IV (184.5 mg Ni/kg bw/d). Further, there was a concomitant rise in the percentage of resorbed, dead, and macerated fetuses in group IV. However, in groups II and III, the dead and macerated fetuses were not observed. At 184.5mgNi/kg b.wt. dose level, the incidence of postimplantation death (35.29%) was evident. No change was evident in the sex ratio (M: F) after oral administration of Ni at all the three dose levels. The average fetal weight significantly reduced (p < 0.01) in a dose-dependent manner. The placental weight decreased nonsignificantly in all the treated groups.
Fetuses with macroscopic anomalies such as open eye lids (10% and 12.50% in groups III and IV), club foot (6.25% in group IV) (Figure 13), and umbilical hernia (5% and 6.25% in groups III and IV) were evident. Ophthalmic anomalies, namely, microphthalmia (5%, 5%, and 6.25% in all the treated groups) and exophthalmia (5% in group III) were observed. The occurrence of hydrocephaly in groups III and IV was 5% and 12.50%, and microcephaly in group III was 5%, respectively. No gross anomalies were seen in group II). The double stained (alizarin red S and alcian blue) skeleton of fetuses showed numerous anomalies such as reduced ossification of nasal, frontal, parietal, intraparietal, and supra-occipital bones of skull, absence or gap between the ribs, reduced or fused sternebrae, reduced/absence/displaced vertebral centra in thoracic and lumbar regions, reduced/ absence of caudal vertebrae, reduced pelvic elements, and absence of carpals,metacarpals, tarsals, metatarsals, and phalanges. The percentage of skeletal anomalies was found to be dose dependent.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 92.25 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- not specified
- Basis for effect level:
- reduction in number of live offspring
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Study rated by an independent reviewer
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