Registration Dossier
Registration Dossier
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: 248-953-3 | CAS number: 28305-25-1
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Reference Type:
- review article or handbook
- Title:
- Calcium Chloride, SIDS Initial Assessment Report For SIAM 15
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS Initial Assessment Report For SIAM 15, Boston, USA, 22-25th October 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Remarks:
- study reported before establishment of GLP guidance
- Limit test:
- no
Test material
- Reference substance name:
- Calcium chloride
- EC Number:
- 233-140-8
- EC Name:
- Calcium chloride
- Cas Number:
- 10043-52-4
- Molecular formula:
- CaCl2
- IUPAC Name:
- calcium dichloride
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material used in the report: calcium chloride
- Batch No.: FDA 71-87
- Appearance: fine white granular material
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- Virgin adult female albino outbred mice were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- gestation day 6 to 15
- Frequency of treatment:
- daily
- Duration of test:
- until gestation day 17
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Negative Control
- Dose / conc.:
- 1.89 mg/kg bw/day (nominal)
- Dose / conc.:
- 8.78 mg/kg bw/day (nominal)
- Dose / conc.:
- 40.8 mg/kg bw/day (nominal)
- Dose / conc.:
- 189 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Remarks:
- Positive control (Aspirin)
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: all animals were observed daily for appearance and behaviour with particular attention to food consumption and weight.
BODY WEIGHT: Yes
- Time schedule for examinations: body weights were recorded on gestation day 0, 6, 11, 15 and 17
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17 - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes, after caesarean section under surgical anesthesia the numbers of implantation sites, resorption sites and live and dead fetuses were recorded.
- Blood sampling:
- n.a.
- Fetal examinations:
- The body weights of the live pups were recorded. In addition, all fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing the Wilson technique. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
- Statistics:
- n.a.
- Indices:
- Numbers of implantation sites, resorption sites, live and dead fetuses, sex ratio
- Historical control data:
- n.a.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- See Table 1 in box " Any other information on results incl. tables".
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See Table 5 in box " Any other information on results incl. tables".
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed/described.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Other effects:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 189 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed at the highest dose tested
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- See Table 2 in box " Any other information on results incl. tables".
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- not examined
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- See Table 3 in box " Any other information on results incl. tables".
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- See Table 4 in box " Any other information on results incl. tables".
- Other effects:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 189 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed at highest dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Fate Summary | |||||||||
Group | Material | Dose | Total | Surviving at Term | |||||
mg/kg bw | Mated | Pregnant | Total | Pregnant* | |||||
341 | Vehicle control | 0 | 25 | 22 | 25 | 22 | |||
342 | Aspirin** | 150 | 25 | 19 | 25 | 19 | |||
347 | CaCl2 | 1.89 | 25 | 22 | 25 | 22 | |||
348 | CaCl2 | 8.78 | 25 | 21 | 24 | 20 | |||
349 | CaCl2 | 40.8 | 25 | 21 | 25 | 21 | |||
350 | CaCl2 | 189.0 | 25 | 23 | 25 | 23 |
*includes all dams examined at term
**positive control
Table 2: Reproduction data | ||||||||
Group | 341 | 342 | 347 | 348 | 349 | 350 | ||
Dose (mg/kg bw) | Neg Con | Aspirin* | 1.89 | 8.78 | 40.8 | 189.0 | ||
Pregnancies | ||||||||
Total No. | 22 | 19 | 22 | 21 | 21 | 23 | ||
Died/aborted before Day 17 | 0 | 0 | 0 | 1 | 0 | 0 | ||
To term (Day 17) | 22 | 19 | 22 | 20 | 21 | 23 | ||
Live Litters | ||||||||
Total No. | 21 | 29 | 21 | 20 | 21 | 21 | ||
Implant Sites | ||||||||
Total No. | 251 | 240 | 244 | 248 | 235 | 272 | ||
Average per dam | 11.4 | 12.6 | 11.6 | 12.4 | 11.2 | 11.8 | ||
Resorptions | ||||||||
Total No. | 19 | 8 | 12 | 7 | 5 | 35 | ||
Dams with 1 or more sites resorbed | 6 | 5 | 8 | 6 | 4 | 13 | ||
Dams with all sites resorbed | 1 | 0 | 1 | 0 | 0 | 2 | ||
% partial resorptions | 27.3 | 26.3 | 36.4 | 30.0 | 19.1 | 56.5 | ||
% complete resorptions | 4.55 | 0 | 4.55 | 0 | 0 | 8.70 | ||
Live Fetuses | ||||||||
Total No. | 229 | 224 | 229 | 238 | 227 | 234 | ||
Average per dam** | 10.4 | 11.8 | 10.4 | 11.9 | 10.8 | 10.2 | ||
Sex ratio (m/f) | 1.16 | 1.07 | 0.80 | 0.84 | 0.89 | 0.93 | ||
Dead Fetuses | ||||||||
Total* | 3 | 8 | 3 | 3 | 3 | 3 | ||
Dams with 1 or more dead | 2 | 6 | 3 | 3 | 3 | 3 | ||
Dams with all dead | 0 | 0 | 0 | 0 | 0 | 0 | ||
Per cent partial dead | 9.09 | 31.6 | 13.6 | 15.0 | 14.3 | 13.0 | ||
Per cent all dead | 0 | 0 | 0 | 0 | 0 | 0 | ||
Average Fetus weight (g) | 0.89 | 0.87 | 0.90 | 0.93 | 0.91 | 0.90 | ||
*positive control
**includes only those dams examined at term
Table 3: Summary of Skeletal findings** | ||||||||
Group No. | 341 | 342 | 347 | 348 | 349 | 350 | ||
Dose (mg/kg bw) | Neg. Con. | Aspirin* | 1.89 | 8.78 | 40.8 | 189.0 | ||
Live fetuses examined (at term) | 158/21 | 160/19 | 160/21 | 162/20 | 159/21 | 161/21 | ||
Sternebrae | ||||||||
Incomplete oss. | 25/10 | 28/10 | 21/11 | 15/6 | 24/10 | 12/5 | ||
Scrambled | ||||||||
Bipartie | 11/9 | 9/7 | 3/3 | 12/8 | 13/10 | 7/6 | ||
Fused | ||||||||
Extra | ||||||||
Missing | 9/7 | 11/5 | 16/10 | 12/5 | 10/6 | 12/5 | ||
Other | ||||||||
Rids | ||||||||
Incomplete oss. | ||||||||
Fused/split | ||||||||
Wavy | 1/1 | |||||||
Less than 12 | ||||||||
More than 13 | 41/14 | 30/12 | 28/12 | 42/14 | 35/14 | 20/12 | ||
Other | ||||||||
Vertebrae | ||||||||
Incomplete oss. | 3/3 | 1/1 | 2/2 | 2/2 | ||||
Scrambled | ||||||||
Fused | ||||||||
Extra crts. Oss. | ||||||||
Scoliosis | ||||||||
Tail defects | ||||||||
Other | ||||||||
Skull | ||||||||
Incomplete closure | ||||||||
Missing | ||||||||
Craniostosis | ||||||||
Other: facial bones, inc 1/1 | ||||||||
Extremities | ||||||||
Incomplete oss. | 1/1 | 1/1 | 1/1 | 2/2 | ||||
Missing | ||||||||
Extra | ||||||||
Miscellaneous | ||||||||
Hyoid, missing | 23/14 | 23/11 | 33/14 | 26/11 | 20/10 | 30/13 | ||
Hyoid, reduced | 23/13 | 4/4 | 22/14 | 12/9 | 23/12 | 12/9 |
*positive control
**numerator= number of fetuses affected, denominator= number of litters affected
Table 4: Summary of Soft Tissue Abnormalities | |||||
Group | Material | Dose (mg/kg bw) | Dam | No. Of Pups | Description |
342 | Aspirin* | 150.0 | A6102 | 1 | Gastroschisis |
349 | CaCl2 | 40.8 | N5070 | 1 | Umbilical hernia |
350 | Cacl2 | 189.0 | N5112 | 1 | Cleft palate |
*positive control
Table 5: Average body weights (g) | |||||||
Group | Material | Dose (mg/kg bw) | Day 0 | Day 6 | Day 11 | Day 15 | Day 17 |
341 | Neg. Con. | 0.0 | 27.7 | 30.6 | 34.5 | 41.1 | 46.8 |
342 | Aspirin* | 150.0 | 28.7 | 31.9 | 35.0 | 43.4 | 50.2 |
347 | CaCl2 | 1.89 | 29.3 | 31.3 | 35.4 | 43.6 | 49.2 |
348 | CaCl2 | 8.78 | 28.7 | 30.7 | 35.2 | 45.2 | 51.5 |
349 | CaCl2 | 40.8 | 29.0 | 30.9 | 35.8 | 44.1 | 50.2 |
350 | CaCl2 | 189.0 | 30.9 | 33.6 | 37.4 | 45.4 | 50.4 |
*positive control
Applicant's summary and conclusion
- Conclusions:
- In this study conducted similar to OECD TG 414, oral administration of calcium chloride given once a day to CD1 mouse dams from Day 6 to 15 of gestation was well tolerated of up to the highest dose applied of 189 mg/kg bw/day. As no adverse results were observed in any examined parameter, the NOAEL for reproductive/developmental and maternal toxicity is considered to be greater than 189 mg/kg bw/day.
- Executive summary:
In a developmental toxicity study conducted similar to OECD TG 414, calcium chloride was administered to groups of 25 pregnant adult female CD1 mice/dose by gavage at dose levels of 0, 1.89, 8.78, 40.8 and 189.0 mg/kg bw/day from day 6 through day 15 of gestation. The animals were sacrificed on gestation day 17.
No treatment-related effects were seen in maternal or offspring survival and no maternal/foetal toxicity was observed. In addition, no differences were seen in either soft or skeletal examinations of the fetuses. As no adverse results were observed in any examined parameter, the NOAEL for reproductive/developmental and maternal toxicity is considered to be greater than 189 mg/kg bw/day.
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.
