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EC number: 233-135-0 | CAS number: 10043-01-3
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
- Principles of method if other than guideline:
- Method: other: OECD TG No. 422 "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test"
- GLP compliance:
- yes
- Remarks:
- Tested by LG Life Science/Toxicology Center, Korea,(Test No. S506),
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium sulfate, dihydrate
- IUPAC Name:
- Calcium sulfate, dihydrate
- Reference substance name:
- 10101-41-4
- EC Number:
- 600-148-1
- Cas Number:
- 10101-41-4
- IUPAC Name:
- 10101-41-4
- Details on test material:
- - Name of test material: Calcium sulfate, dihydrate
- Molecular formula (if other than submission substance): CaSO4•2H2O
- Molecular weight (if other than submission substance): 172.171
- Smiles notation (if other than submission substance): O.O.[O-]S(=O)(=O)[O-].[Ca+2]
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Density -2.32 g/cm3)
- Solubility in water - 2.05 g/L at 20 °C
- Synonyms: Alabaster
Annaline
C.I. Pigment white 25
Gypsum
Gypsum stone
Land and plaster
Light spar
Magnesia white
Mineral white
Native calcium sulfate
Precipitated calcium sulfate
Sainite
Satin spar
Sulfuric acid, calcium(2+) salt, dihydrate
Terra alba
- Calcium sulfate, dihydrate consists of colorless, monoclinic and hygroscopic crystals
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Test organism
- Sex: male/female
- Age of animals at study: 8 weeks old for males and females
- Weight at study repeated dose toxicity: 254.2 - 297.8 g for males and
182.7 - 208.2 g for females
- Number of test animals: 60 animals for each sex
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- not specified
- Details on exposure:
- Dose level : 0, 100, 300 and 1,000 mg/kg/day; pre-treatment (Test No. P705) had conducted with 0, 125, 250, 500 and 1,000 mg/kg/day of test substance for 7 days to determine the appropriate starting dose level.
Exposure period : 35 days for male animals and 41 to 45 days for female animals
Frequency of treatment : Daily
Control group : Yes Concurrent no treatment - Details on mating procedure:
- - Mating procedure: each male and female animal was selected from the same test group in order to copulate. It spent 4 days in terms of mating.
The day after the copulating, mating would be determined through the observation of sperm in a vaginal rinse.
- Clinical observations performed and frequency: Clinical symptoms were observed once a day but were observed once a week in detail; a
death rate was observed twice a day; and body weight was observed once a week and just before the necropsy but in case of pregnant
females, it was measured on the day 0, 7, 14, 20 of gestation period, date of delivery, and 4 days after the delivery; consumption rate of
fodder was observed once a week except mating period. - Duration of treatment / exposure:
- 35 days for male animals and 41 to 45 days for female animals
- Frequency of treatment:
- Daily
- Duration of test:
- 35 days for male animals and 41 to 45 days for female animals
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 and 1,000 mg/kg/day; pre-treatment (Test No. P705) had conducted with 0, 125, 250, 500 and 1,000 mg/kg/day of test substance for 7 days to determine the appropriate starting dose level.
Basis:
nominal in diet
- No. of animals per sex per dose:
- - Number of test animals: 60 animals for each sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Sex: male/female
Dose level : 0, 100, 300 and 1,000 mg/kg/day; pre-treatment (Test No. P705) had conducted with 0, 125, 250, 500 and 1,000 mg/kg/day of test substance for 7 days to determine the appropriate starting dose level.
Exposure period : 35 days for male animals and 41 to 45 days for female animals
Frequency of treatment : Daily
Examinations
- Maternal examinations:
- - Clinical observations performed and frequency: Clinical symptoms were observed once a day but were observed once a week in detail; a
death rate was observed twice a day; and body weight was observed once a week and just before the necropsy but in case of pregnant
females, it was measured on the day 0, 7, 14, 20 of gestation period, date of delivery, and 4 days after the delivery; consumption rate of
fodder was observed once a week except mating period.
Organs examined at necropsy:
Organ weight: testes, epididymider (all males) liver, kidney, adrenals, thymus, spleen, brain, and heart (5 male and female animals from each
test group).
Fixation: 22 kinds of tissues were fixed to do histopathologic tests such as testes, epididymides, ovaries, accessory sex organs for all animals,
brain (including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including peyer’s patches), liver, kidneys,
adrenals, spleen, heart, thymus, thyroid, trachea, lungs, uterus, urinary bladder, lymph nodes (cervical mesenteric), peripheral nerve (sciatic or
tibial), bone marrow. - Ovaries and uterine content:
- Fixation: 22 kinds of tissues were fixed to do histopathologic tests such as testes, epididymides, ovaries, accessory sex organs for all animals,
brain (including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including peyer’s patches), liver, kidneys,
adrenals, spleen, heart, thymus, thyroid, trachea, lungs, uterus, urinary bladder, lymph nodes (cervical mesenteric), peripheral nerve (sciatic or
tibial), bone marrow. - Fetal examinations:
- Fixation: 22 kinds of tissues were fixed to do histopathologic tests such as testes, epididymides, ovaries, accessory sex organs for all animals,
brain (including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including peyer’s patches), liver, kidneys,
adrenals, spleen, heart, thymus, thyroid, trachea, lungs, uterus, urinary bladder, lymph nodes (cervical mesenteric), peripheral nerve (sciatic or
tibial), bone marrow.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Pregnancy and delivery: There was no significant difference between the treatment and the control group in terms of delivery and; the number
of corpus luteum and implantation. Some test groups including the control group had quite higher loss rate of the embryo prior to the
implantation and the fetus after the implantation but significant difference was not observed between the treatment and the control
group. These higher loss rate were occurred spontaneously and no dose-response correlation. Thus no influence under test substance. In
addition, there were no premature pups.
- Clinical signs: In male control group, a case of salivation and bloodylike secretion was observed on the day 11 and 12. In the 1,000
mg/kg/day treatment group, a case of depilation, dcab and pus was observed on the left cheek between the day 25 and the closing day.
However, the frequency of occurrence was low and no dose-response correlation, thus these symptoms were not influenced by test substance.
In female control group, a case of genitalia bloody-like secretion was observed at day 29. In the 100 mg/kg/day treatment group, each case of
hypoactivity and depilation was observed on the day 8 and 9, and between day 44 and the closing day, respectively. However, these
symptoms were disappeared in short, thus these did not have relationship with test substance.
- Necropsy opinions: For male animals, in the control group within the recovery group, a case of left and right caput epididymis cyst was
observed and the 1,000 mg/kg/day recovery group had symptom of right caput epididymis cyst. However, its frequency of occurrence was low
and it was even observed at the control group within the recovery group, so it did not have relationship with test substance.
For female animals, in the 300 mg/kg/day treatment group, each animal was dead on the day 7 and 14 and; each case of lung dark-red
discolouration was observed, but white particles in a lobe of the lung was observed just from one of carcasses. A case of spleen white nodule
was observed for an animal in the 300 mg/kg/day treatment group. There was a case of right adrenal gland white spots at the 1,000
mg/kg/day treatment group. In the control group within the recovery group, each case of right adrenal gland hemorrhagia and atrophy and
liver adhesion with diaphragm was observed. However, their frequencies of occurrence were low and no dose-response correlation,
so these did not have relationship with test substance.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Results for F1
- Examination of the external surface of pups: At the time of the delivery
and on the day 4, in the every test group including the control group, no
observation in relation to runt, malformation, and variance was found. A
case of malrotated limb was observed at the 1,000 mg/kg/gay treatment
group but its frequency was insignificant and no relation with test
substance.
- Body weight of pups: In the male pups, total 3 cases of underweight
were observed from the control group and the treatment group with
administration of 100 mg/kg/day, but no significant difference was found
between the two. On the day 4 after the delivery, in the nursing pups, 1,
1, 2 cases of underweight were observed for the control group, the 100
mg/kg/day treatment group and the 1,000 mg/kg/day treatment group,
respectively, and no significant differences was found between the
control group and the treatment group.
In the female pups, total 6 cases of underweight were observed from the
following three groups such as the control group, the 100 mg/kg/day
treatment group and the 1,000 mg/kg/day treatment group. On the day 4
after the delivery, in the nursing pups, 1, 2, 3 cases of underweight were
observed for the control group, the 100 mg/kg/day treatment group and
the 1,000 mg/kg/day treatment group, respectively. In addition, the both
100 mg/kg/day and 1,000 mg/kg/day treatment groups had lower body
weight than that of the control group. However, their weights were in the
normal range of pups.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
Results for F0
- Pregnancy and delivery: There was no significant difference between the treatment and the control group in terms of delivery and; the number of corpus luteum and implantation. Some test groups including the control group had quite higher loss rate of the embryo prior to the implantation and the fetus after the implantation but significant difference was not observed between the treatment and the control group. These higher loss rate were occurred spontaneously and no dose-response correlation. Thus no influence under test substance. In addition, there were no premature pups.
- Clinical signs: In male control group, a case of salivation and bloody-like secretion was observed on the day 11 and 12. In the 1,000 mg/kg/day treatment group, a case of depilation, dcab and pus was observed on the left cheek between the day 25 and the closing day. However, the frequency of occurrence was low and no dose-response correlation, thus these symptoms were not influenced by test substance. In female control group, a case of genitalia bloody-like secretion was observed at day 29. In the 100 mg/kg/day treatment group, each case of hypoactivity and depilation was observed on the day 8 and 9, and between day 44 and the closing day, respectively. However, these symptoms were disappeared in short, thus these did not have relationship with test substance.
- Necropsy opinions: For male animals, in the control group within the recovery group, a case of left and right caput epididymis cyst was observed and the 1,000 mg/kg/day recovery group had symptom of right caput epididymis cyst. However, its frequency of occurrence was low and it was even observed at the control group within the recovery group, so it did not have relationship with test substance.
For female animals, in the 300 mg/kg/day treatment group, each animal was dead on the day 7 and 14 and; each case of lung dark-red discolouration was observed, but white particles in a lobe of the lung was observed just from one of carcasses. A case of spleen white nodule was observed for an animal in the 300 mg/kg/day treatment group. There was a case of right adrenal gland white spots at the 1,000 mg/kg/day treatment group. In the control group within the recovery group, each case of right adrenal gland hemorrhagia and atrophy and liver adhesion with diaphragm was observed. However, their frequencies of occurrence were low and no dose-response correlation, so these did not have relationship with test substance.
Results for F1
- Examination of the external surface of pups: At the time of the delivery and on the day 4, in the every test group including the control group, no observation in relation to runt, malformation, and variance was found. A case of malrotated limb was observed at the 1,000 mg/kg/gay treatment group but its frequency was insignificant and no relation with test substance.
- Body weight of pups: In the male pups, total 3 cases of underweight were observed from the control group and the treatment group with administration of 100 mg/kg/day, but no significant difference was found between the two. On the day 4 after the delivery, in the nursing pups, 1, 1, 2 cases of underweight were observed for the control group, the 100 mg/kg/day treatment group and the 1,000 mg/kg/day treatment group, respectively, and no significant differences was found between the control group and the treatment group.
In the female pups, total 6 cases of underweight were observed from the following three groups such as the control group, the 100 mg/kg/day treatment group and the 1,000 mg/kg/day treatment group. On the day 4 after the delivery, in the nursing pups, 1, 2, 3 cases of underweight were observed for the control group, the 100 mg/kg/day treatment group and the 1,000 mg/kg/day treatment group, respectively. In addition, the both 100 mg/kg/day and 1,000 mg/kg/day treatment groups had lower body weight than that of the control group. However, their weights were in the normal range of pups.
Applicant's summary and conclusion
- Conclusions:
- NOAEL for developmental : The highest test dose (1,000 mg/kg/day) for male and female
animals
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