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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)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 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
- Sex:
- male/female
- 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
- Group composition: twelve animals (6 male + 6 female) were
allocated as a recovery group for the control (0 mg/kg/day) and T3 (100
mg/kg/day) group.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral 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 the 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) - Duration of treatment / exposure:
- 35 days for male animals and 41 to 45 days for female animals
- Frequency of treatment:
- daily
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 the 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
- Group composition: twelve animals (6 male + 6 female) were allocated as a recovery group for the control (0 mg/kg/day) and T3 (100
mg/kg/day) group. - Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: no data
Examinations
- Observations and examinations performed and frequency:
- - 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.
- Tests for sensory organ and reflex action: 5 animals were randomly selected from each test group. Both preyer reflex test and corneal reflex
test were performed before necropsy and during lactation for males and females, respectively.
- Behaviour test: 5 animals were randomly selected from each test group to do grip strength test in terms of behaviour test. This test was
performed before necropsy and during lactation for males and females, respectively.
- Haematological and biochemical test of blood: randomly selected 5 male and female animals from each test group were fasted a day before
necropsy for both tests. Animals were anesthetized using ether and cut the abdomen open to collect blood. In case of the haematological test, blood
coagulation preventative chemicals for the test of blood coagulation and the calculation of blood-corpuscles were 3.2 % sodium citrate and EDTA-
2K, respectively. On the other hand, blood coagulation preventative chemical was not used for the biochemical test, but gathered blood was
left itself in the room temperature then the sera were separated using a centrifuge. For haematological test, 6 following items were measured;
Haematocrit, hemoglobin concentration, erythrocyte count, total and different leucocyte count, platelet count, prothrombin time, and active
partial thromboplastin time. For biochemical test of blood, eleven following items were measured; sodium, potassium, glucose, total cholesterol,
blood urea nitrogen, creatinine, total protein, albumin, alanine aminotransferase, aspatate aminotransferase, and total bilirubin. - Sacrifice and pathology:
- 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), and bone marrow - Statistics:
- Statistical decision tree, but in case of recovery group, either twoside Student’s t-test or two-side Aspin-Welch t-test was used.
In case of categorical data, two-sided Fisher’s exact test was used.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There was one death at day 8 for male, and each death on the day 7 and 14 for female in the treatment group of 300 mg/kg/day. These were occurred during the administration process, so it did not have relationship with test substance.
- Mortality:
- no mortality observed
- Description (incidence):
- There was one death at day 8 for male, and each death on the day 7 and 14 for female in the treatment group of 300 mg/kg/day. These were occurred during the administration process, so it did not have relationship with test substance.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In male groups, temporarily, a case of diminishment in the amount of body weight change was observed at week 2 within the control group in which some clinical signs were observed such as damage to esophagus. Body weight loss for female animals was observe
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No crucial difference between the treatment group and the control group was observed for both male and female animals during test period. For recovery group, no significant change was observed within themselves.
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 100 mg/kg/day BUN (Blood urea nitrogen) was decreased .The values of TP (Total Protein), ALB (Albumin), BUN (Blood Urea Nitrogen), and CREA (Creatinine) were decreased significantly at the 300 mg/kg bw/day and 1,000 mg/kg bw/day treatment for males
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 100 mg/kg/day BUN (Blood urea nitrogen) was decreased .The values of TP (Total Protein), ALB (Albumin), BUN (Blood Urea Nitrogen), and CREA (Creatinine) were decreased significantly at the 300 mg/kg bw/day and 1,000 mg/kg bw/day treatment for males
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- - Mortality: There was one death at day 8 for male, and each death on the day 7 and 14 for female in the treatment group of 300 mg/kg/day.
These were occurred during the administration process, so it did not have relationship with test substance.
- Body weight: In male groups, temporarily, a case of diminishment in the amount of body weight change was observed at week 2 within the
control group in which some clinical signs were observed such as damage to esophagus. Body weight loss for female animals was observed several
times during lactation period in every treatment group including the control group. However, these were occurred temporarily because of the lactation.
- 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.
- Amount of fodder consumption: No crucial difference between the treatment group and the control group was observed for both male and
female animals during test period. For recovery group, no significant change was observed within themselves.
- Test of reflex action: Five male and female animals were randomly selected from each test group, in which no specific reaction was observed.
- Grip strength test: For male animals, 6 animals were left out from the treatment group. For female animals, 5 animals were left out from the
control group, and the treatment group. All things being considered, there was no dose-response correlation and was no illness at the related organs
such as the cerebellum and muscle.
- Organ weight: Both absolute weight of the liver and the left kidney were increased at the recovery group with administration of 1,000 mg/kg/day
as compared with that of the control group within the recovery group. There was no histopathological illness at the organs, so increased organ
weight 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 particle 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.
- Analysis of haematological test of blood: In the 1,000 mg/kg/day male recovery group, segments were increased (p < 0.05) in contrast with that
of the control group within the recovery group. Prothrombin time (PT) was decreased in the 1,000 mg/kg/day female recovery group in
comparison with that of the control group within the recovery group. However, these symptoms were not observed in the definitive test
groups, so these symptoms were not influenced by test substance. In addition, level of WBC (white blood cell) was increased (p < 0.001) in the
100 mg/kg/day female treatment group in contrast with that of the control group. However, its increased value was in the normal range and no
dose-response correlation, so it did not have relationship with test substance.
- Analysis of biochemical test of blood: In the 100 mg/kg/day treatment group for male animals, BUN (Blood urea nitrogen) was decreased as
compared with that of the control group. The male treatment groups with both administration of 300 mg/kg/day and the 1,000 mg/kg/day
decreased in TP (Total protein), ALB (Albumin), AST (Aspatate aminotransferase), ALT (Alanine aminotransferase), BUN (Blood urea nitrogen), CREA (Creatinine), Na (Sodium), TCHO (Total cholesterol), and Cl (Chloride) as compared with those of the control group. In case of the 1,000 mg/kg/day male recovery group, the value of AST was decreased significantly in contrast with that of the control group within the recovery group. No significant difference was found at every test item between female control and treatment group. The female recovery group with administration of 1,000 mg/kg/day decreased in AST in contrast with that of the control group within the recovery group, but TCHO and GLU (Glucose) were increased. In fact, decreased values of AST and ALT could be no toxicological effects. In addition, the changed values of AST, TCHO, and GLU in this test were in the normal range and no histopathological opinion in terms of related organs, so these changed values were not influenced by test substance. However, decreased values of TP, ALB, BUN, and CREA were possibly influenced by excretion process or metabolism of test substance in relation to the kidney, and these symptoms were possibly recovered in 2 weeks from reversible effects.
- Histopathology: For male animals, in the control group, each case of heart focal inflammatory cell infiltration, submadibular lymph node
blood absorption, liver mononuclear cell foci, and adrenal gland cortical vacuolation was observed. In the 300 mg/kg/day treatment
group, two cases of pancreas vacuolation, and a case of liver mononuclear cell foci were observed. In the treatment group with administration of 1,000 mg/kg/day, there were three cases of liver mononuclear cell foci; and a case of heart focal inflammatory cell infiltration was found.
For female animals, in the control group, two cases of liver mononuclear cell foci, a case of kidney cortical scaring, and a case of pancreas
vacuolation were observed. In the treatment group with administration of 100 mg/kg/day, one case of esophagus submucosal gland proliferation
was observed. In the 300mg/kg/day treatment group, a case of trachea submucosal gland proliferation was observed. In the 1,000 mg/kg/day
treatment group, each case of pancreas vacuolation and liver mononuclear cell foci was observed. However, these symptoms for both sexes were just subtle level and were occurred spontaneously, so there was no significant difference between the treatment group and the control group.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
Results for F0
- Mortality: There was one death at day 8 for male, and each death on the day 7 and 14 for female in the treatment group of 300 mg/kg/day. These were occurred during the administration process, so it did not have relationship with test substance.
- Body weight: In male groups, temporarily, a case of diminishment in the amount of body weight change was observed at week 2 within the control group in which some clinical signs were observed such as damage to esophagus. Body weight loss for female animals was observed several times during lactation period in every treatment group including the control group. However, these were occurred temporarily because of the lactation.
- 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.
- Amount of fodder consumption: No crucial difference between the treatment group and the control group was observed for both male and female animals during test period. For recovery group, no significant change was observed within themselves.
- Test of reflex action: Five male and female animals were randomly selected from each test group, in which no specific reaction was observed.
- Grip strength test: For male animals, 6 animals were left out from the treatment group. For female animals, 5 animals were left out from the control group, and the treatment group. All things being considered, there was no dose-response correlation and was no illness at the related organs such as the cerebellum and muscle.
- Organ weight: Both absolute weight of the liver and the left kidney were increased at the recovery group with administration of 1,000 mg/kg/day as compared with that of the control group within the recovery group. There was no histopathological illness at the organs, so increased organ weight 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 particle 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.
- Analysis of haematological test of blood: In the 1,000 mg/kg/day male recovery group, segments were increased (p < 0.05) in contrast with that of the control group within the recovery group. Prothrombin time (PT) was decreased in the 1,000 mg/kg/day female recovery group in comparison with that of the control group within the recovery group. However, these symptoms were not observed in the definitive test groups, so these symptoms were not influenced by test substance. In addition, level of WBC (white blood cell) was increased (p < 0.001) in the 100 mg/kg/day female treatment group in contrast with that of the control group. However, its increased value was in the normal range and no dose-response correlation, so it did not have relationship with test substance.
- Analysis of biochemical test of blood: In the 100 mg/kg/day treatment group for male animals, BUN (Blood urea nitrogen) was decreased as compared with that of the control group. The male treatment groups with both administration of 300 mg/kg/day and the 1,000 mg/kg/day decreased in TP (Total protein), ALB (Albumin), AST (Aspatate aminotransferase), ALT (Alanine aminotransferase), BUN (Blood urea nitrogen), CREA (Creatinine), Na (Sodium), TCHO (Total cholesterol), and Cl (Chloride) as compared with those of the control group. In case of the 1,000 mg/kg/day male recovery group, the value of AST was decreased significantly in contrast with that of the control group within the recovery group.
No significant difference was found at every test item between female control and treatment group. The female recovery group with administration of 1,000 mg/kg/day decreased in AST in contrast with that of the control group within the recovery group, but TCHO and GLU (Glucose) were increased.
In fact, decreased values of AST and ALT could be no toxicological effects. In addition, the changed values of AST, TCHO, and GLU in this test were in the normal range and no histopathological opinion in terms of related organs, so these changed values were not influenced by test substance. However, decreased values of TP, ALB, BUN, and CREA were possibly influenced by excretion process or metabolism of test substance in relation to the kidney, and these symptoms were possibly recovered in 2 weeks from reversible effects.
- Histopathology: For male animals, in the control group, each case of heart focal inflammatory cell infiltration, submadibular lymph node blood absorption, liver mononuclear cell foci, and adrenal gland cortical vacuolation was observed. In the 300 mg/kg/day treatment group, two cases of pancreas vacuolation, and a case of liver mononuclear cell foci were observed. In the treatment group with administration of 1,000 mg/kg/day, there were three cases of liver mononuclear cell foci; and a case of heart focal inflammatory cell infiltration was found.
For female animals, in the control group, two cases of liver mononuclear cell foci, a case of kidney cortical scaring, and a case of pancreas vacuolation were observed. In the treatment group with administration of 100 mg/kg/day, one case of esophagus submucosal gland proliferation was observed. In the 300mg/kg/day treatment group, a case of trachea submucosal gland proliferation was observed. In the 1,000 mg/kg/day treatment group, each case of pancreas vacuolation and liver mononuclear cell foci was observed. However, these symptoms for both sexes were just subtle level and were occurred spontaneously, so there was no significant difference between the treatment group and the control group.
For more details or results, see attached document.
Applicant's summary and conclusion
- Conclusions:
- There was no specific opinion about test items such as clinical symptoms, body weight change, food consumption, reflex action, and necropsy, etc. under the influence of test substance. However, in case of male animals, the repeated dose toxicity test of more than 35 days affect at the kidney subtle level, so LOAEL and NOAEL were determined as 300 mg/kg/day and 100 mg/kg/day, respectively. In case of female animals, no effects were observed at the top dose tested.
- Executive summary:
In a gavage study in Sprague-Dawley rats in accordance with OECD TG 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Screening Test was conducted. The rats were exposed to calcium sulfate, dihydrate at level of 0, 100, 300 and 1,000 mg/kg bw/day for more than 35 days and 41 - 45 days for male and female animals, respectively. 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 bw/day recovery group had symptom of right caput epididymis cyst. For female animals, in the 300 mg/kg bw/day treatment group, one animal was died on day 7 and another on day 14 and in each case dark-red discolouration of the lung was observed, but white particles in a lobe of the lung were observed just in one dead animal. However, its frequency of occurrence was quite low.
After all, calcium sulfate, dihydrate had no critical influence on test items such as mortality, body weights (organ weight), food consumption, necropsy and behaviour of the animals. However, the values of TP (Total Protein), ALB (Albumin), BUN (Blood Urea Nitrogen), and CREA (Creatinine) were decreased significantly at the 300 mg/kg bw/day and 1,000 mg/kg bw/day treatment for male animals in accordance with analysis of biochemical test of blood, for the test substance might affect the excretion process, distribution or metabolism of the test substance in relation to the kidney. On the other hand, no significant difference was found at every test item between female controls and treatment groups. There were some changed values in the female recovery group for AST, TCHO and GLU, but these were in the normal range and there was no dose-response relationship. Therefore, LOAEL and NOAEL for male animals were determined to be 300 mg/kg bw/day and 100 mg/kg bw/day, respectively. (National Institute of Environmental Research (NIER), 2002, Calcium sulfate dihydrate: Combined Repeated Dose Toxicity with the Reproduction/Developmental Toxicity Screening Test (Test No. S506)). For female rats, no effects were observed at the top dose tested (1,000 mg/kg bw/day).
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