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EC number: 299-370-6 | CAS number: 93859-32-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from OECD SIDS
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Profile- Calcium stearate
- Author:
- Organization for Economic Cooperation and Development
- Year:
- 2 012
- Bibliographic source:
- CoCAM 2, 17-19 April 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Reproductive and developmental toxicity screening test of Calcium distearate in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Calcium distearate
- EC Number:
- 216-472-8
- EC Name:
- Calcium distearate
- Cas Number:
- 1592-23-0
- Molecular formula:
- C18H36O2.1/2Ca
- IUPAC Name:
- calcium dioctadecanoate
- Reference substance name:
- Calcium Stearate
- IUPAC Name:
- Calcium Stearate
- Test material form:
- solid
- Details on test material:
- Name of test material (as cited in study report): Calcium StearateMolecular formula : C36H70CaO4 Molecular weight: 607.04 g/mole Smiles notation :C(CCCCCCCCCCC)CCCCCC(=O)[O].C(CCCCCCCCCCC)CCCCCC(=O)[O].[Ca+2]InChl:1S/2C18H36O2.Ca/c2*123456789101112131415161718(19)20;/h2*217H2,1H3,(H,19,20);/q;;+2/p2Substance Type: OrganicPhysical State: Solid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Calcium distearate- Molecular formula (if other than submission substance): C36H70O4.Ca- Molecular weight (if other than submission substance): 607.023 g/mole- Substance type: Organic- Physical state: White powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Crl:CD(SD) Rat- Age at study initiation: (P) 8 wk- Weight at study initiation: (P) Males: 230.4-275.9 g;Females: 184.3-212.5 g- Housing:- Quarantine and acclimatization : The five animals per cage were housed in stainless steel cages- Administration : The two animals per cage were housed in stainless steel cages- Mating period : One female to one male were housed in stainless steel cages- Gestation and lactation period : Maternal rats and fetuses were housed individually in polycarbonate cages- Diet : ad libitum- Water : ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22.3 - 23.7 °C- Humidity (%): 50.0 - 55.7 %- Air changes (per hr): 10- 15 times/hr- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle (light during 8:00-20:00) at 150 to 300 Lux.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on mating procedure:
- - M/F ratio per cage: One female to one male- Length of cohabitation: 7 days- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy- After 7 days of unsuccessful pairing replacement of first male by another male with proven fertility.- Further matings after two unsuccessful attempts: [no / yes (explain)] -- After successful mating each pregnant female was caged (how): Each pregnant female was caged individually in cage- Any other deviations from standard protocol:-
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- -Male : Two weeks before mating to the end of the mating period, for at least 28 or more days-Female : Two weeks before mating to day 3 of lactation including the mating and gestation period
- Frequency of treatment:
- once a day, 7 days a week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Total: 800 mg/kg bw/day: 10 male, 10 female 250 mg/kg bw/day: 10 male, 10 female 500 mg/kg bw/day: 10 male, 10 female 1000 mg/kg bw/day: 10 male, 10 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In the preliminary toxicity study (KTR Study No. : TBH-902), at a dose level of 1000 mg/kg bw/day in SD rats, there was no treatment-related changes. Based on above results, 1000 mg/kg bw/day was selected as the high dose for the reproduction/developmental toxicity screening study and two lower doses were added with 2 fold interval.- Rationale for animal assignment: The animal strain was chosen because the SD rats are commonly used for reproductive toxicity testing and abundant background data are available to assist evaluation of the results.
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS:No data - Time schedule: - Cage side observations checked in table [No.?] were included. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: BODY WEIGHT: Yes - Time schedule for examinations: FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): - Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day:No data - Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data - Time schedule for examinations: OTHER: No data
- Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- No data
- Litter observations:
- No data
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: yesHISTOPATHOLOGY: yes
- Postmortem examinations (offspring):
- GROSS PATHOLOGY: yesHISTOPATHOLOGY: yes
- Statistics:
- No data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Alopecia was observed in the vehicle control and treatment groups of both sexes. In males, 2 [1104, 1107] and [ R1201] animals were observed of 0 and 250 mg/kg bw/day groups, respectively. In females, 1 [2106], 1 [2201], 1 [2308] and 2 [2404, 2405] animals were observed of 0, 250, 500 and 1000 mg/kg bw/day groups, respectively. Cannibalism, 1 [2107 : 1 death/140 total fetus (group)], 1 [2207 : 1 death/134 total fetus (group)] and 1 [2409 : 2 death/137 total fetus (group)] were observed of 0, 250 and 1000 mg/kg bw/day groups, respectively.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated male and female rats.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no statistically significant changes in body weights were observed in treatment groups.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant decrease in food consumption was observed at 2 weeks in 1000 mg/kg bw/day group.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In all reproductive organs in control and high dose groups, the lesion related with the test article was not observed.Adrenocortical necrosis was observed in 1 female of the 250 mg/kg bw/day group
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- TThere was no statistically significant difference in Estrus Cycle among the groups.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There was no statistically significant difference in mating, fertility and pregnant index among the groups.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Alopecia occurred in some parent animals, but this was thought to be a sporadically occurring sign due to a genetic and/or environmental factor specific to the SD rats, not related to the test article.
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on survival of pups were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No treatment-related changes were observed of Calcium distearate in body weight during the prenatal, postnatal and lactation period
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Decrease of food consumption at 2 weeks after administration of 1000 mg/kg bw/day group was considered to be incidental since it was transient during the study period.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment-related changes were observed of Calcium distearate in organ weights during the prenatal, postnatal and lactation period
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Splenomegaly was observed in male of the control group. This was considered to be a sporadically occurring sign.Cannibalism was observed in treatment groups, which was occurred commonly in normal parturition and lactation period, because of behavior or environment factor
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Testicular atrophy was observed in male of the 1000 mg/kg/day group, however, there was no toxic effect of the test article on these organs in histopathology; therefore, this was considered to be a sporadically occurring sign. Discoloration of adrenal gland in female of the 250 mg/kg bw/day group was not considered to be toxicological significance, since no treatment-related change was found in histopathological examination.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
No statistically significant differences were seen in the following parameters examined: gestation period, the number of corpora lutea and implantation, delivery index, the number of live and dead pups, the percentage of live and dead pups to implantations, pre-implantation loss, post-implantation loss, sex ratio, viability ratio, number of neonates with external anomalies, and body weights of pups on post-natal day 0 and day 4.
Applicant's summary and conclusion
- Conclusions:
- NOAEL of Calcium distearate was considered to be 1000 mg/kg bw/day for reproduction/developmental toxicity in parent animals and for F1 pups.
- Executive summary:
In a reproductive and developmental toxicity screening test, Sprague-Dawley male and female rats were treated with Calcium distearate in the concentration of 0, 250, 500 and 1000 mg/kg bw orally by gavage. No effect on survival of treated male and female rats was observed as compared to control. Alopecia was observed in the vehicle control and treatment groups of both sexes. In males, 2 and animals were observed in 0 and 250 mg/kg bw/day groups, respectively. In females, 1, 1, 1 and 2 animals were observed at 0, 250, 500 and 1000 mg/kg bw/day groups, respectively. Cannibalism, 1 [1 death/140 total fetus (group)], 1 [ 1 death/134 total fetus (group)] and 1 [2 death/137 total fetus (group)] were observed at 0, 250 and 1000 mg/kg bw/day groups, respectively. No effect on body weight of treated rats was observed as compared to control. Statistically significant decrease in food consumption was observed at 2 weeks in 1000 mg/kg bw/day group. Similarly, No effect on reproductive parameters such as Estrus Cycle, mating, fertility and pregnant index of treated rats. Splenomegaly and testicular atrophy were observed in 1 male of the 0 and 1000 mg/kg bw/day groups, respectively. Discoloration of adrenal gland was observed in 1 female of the 250 mg/kg bw/day group. In all reproductive organs in control and high dose groups, the lesion related with the test article was not observed. Adrenocortical necrosis was observed in 1 female of the 250 mg/kg bw/day group. In addition, no effect on viability and body weight of pups on day 0 and 4 were observed. Decrease of food consumption at 2 weeks after administration of 1000 mg/kg bw/day group was considered to be incidental since it was transient during the study period. No effect on organ weight of treated pups was observed as compared to control. Cannibalism was observed in treatment groups, which was occurred commonly in normal parturition and lactation period, because of behavior or environment factor. Testicular atrophy was observed in male at 1000 mg/kg/day group, however, there was no toxic effect of the test article on these organs in histopathology; therefore, this was considered to be a sporadically occurring sign. Discoloration of adrenal gland in female of the 250 mg/kg bw/day group was not considered to be toxicological significance, since no treatment-related change was found in histopathological examination. Therefore, NOAEL was considered to be 1000 mg/kg bw for P and F1 generation when Sprague-Dawley male and female rats were treated with Calcium distearate orally.
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