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EC number: 233-141-3 | CAS number: 10043-67-1
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study but not according OECD guideline
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the toxicity of insecticides and food additives in pregnant rats. 2. Fetal toxicity of alum
- Author:
- Kanoh, S., Ema, M., Kawasaki, H.
- Year:
- 1 982
- Bibliographic source:
- Pharmacometrics, 24 (1), pp. 65-69
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Al2(SO4)3*K2SO4*24H2O
- IUPAC Name:
- Al2(SO4)3*K2SO4*24H2O
- Details on test material:
- Aluminium potassium bis(sulphate) as 24-hydrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Environmental conditions:Temperature: 24+/- 1°CRelative humidity: 55+/- 5%
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Teratogenic effect of alum[Al2(SO4)3 . K2SO4 . 24H2O] was examined inWistar rats fed the diet containing 10, 2.5 or 0.32% of alum for seven days atthe second trimester of gestation. The effect on fetuses at day 20 of pregnancyand the effect on neonatal growth for four weeks after birth were examined.
- Frequency of treatment:
- Feeding: daily for 7 days at the second week of gestation
- Duration of test:
- Oral exposure: 7 days at the second week of gestationTotal test duration: 28 days
- No. of animals per sex per dose:
- 16 female per dose
- Control animals:
- yes
Examinations
- Maternal examinations:
- Acute oral toxicity of female rats.Survival, food intake, body weight, relative organ weight of uterus and liver.
- Ovaries and uterine content:
- Uterus weight
- Fetal examinations:
- Food intake, substance intake, survival, live fetuses, weight, number of fetuses with external malfunctions, skeletal and visceral examinations
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:In acute oral toxicity of female rats no lethal effect was observed at dosesof 2.0, 1.0, 0.5 and 0.25 g/kg, but relative weight of liver was significantlyreduced in all experimental groups.Maternal body weight gain and food intake were reduced according to the dose of the substance.There were no differences among all the groups in the numbers of implantations andresorptions, but fetal weight in substance-administered groups was significantlyreduced compared with control.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- other: LD0
- Effect level:
- >= 250 - <= 2 000 other: mg/kg bw
- Based on:
- test mat.
- Remarks:
- as AlK(SO4)2*12 H20
- Basis for effect level:
- other: other:
- Dose descriptor:
- other: LD0
- Effect level:
- >= 136 - <= 1 088 other: mg/kg bw
- Based on:
- test mat.
- Remarks:
- calculated as AlK(SO4)2 anhydrous
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:No external malformation of fetuses was observedin any group. Skeletal and visceral observations of fetuses indicated that therewas no significant difference in frequency of anomalies between control andexperimental groups.No adverse effect on postnatal growth was observed in 0.32%group, but the offspring in 10% group showed slow postnatal body weight gain.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.32 - <= 10 other: % in diet
- Based on:
- test mat.
- Remarks:
- as AlK(SO4)2*12H2O in diet
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 121 - <= 4 031 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- calculated as AlK(SO4)2 anhydrous
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In the acute oral toxicity of female rats, no lethal effect was observed at dosesof 2.0, 1.0, 0.5 and 0.25 g/kg bw, but relative weight of liver was significantlyreduced in all experimental groups.In the teratogenic study, maternal bodyweight gain and food intake were reduced according to the dose of alum. Therewere no differences among all the groups in the numbers of implantations andresorptions, but fetal weight in alum-administered groups was significantlyreduced compared with control. No external malformation of fetuses was observedin any group. Skeletal and visceral observations of fetuses indicated that therewas no significant difference in frequency of anomalies between control andexperimental groups. No adverse effect on postnatal growth was observed in 0.32%group, but the offspring in 10% group showed slow postnatal body weight gain.From above results, it is concluded that alum possesses no teratogenic effect inrats fed the diet containing ranging from 0.32 to 10% during the secondtrimester of gestation.Calculated for Aluminium potassium bis sulphate anhydrous:LD0 = 250 - 2000 mg AlK(SO4)2*12 H2O/kg bw = 136 mg/kg bw - 1088 mg /kg bw Aluminium potassium bis sulphate.NOAEL: 0.32-10% Aluminium potassium bis sulphate*24H2O or AlK(SO4)2*12 H2O in diet - no teratogenic effects in rats.Calculated for Aluminium potassium bis sulphate anhydrous: NOAEL: 121 - 4031 mg/kg bw/day Aluminium potassium bis sulphate anhydrous - no teratogenic effects in rats.
- Executive summary:
In the acute oral toxicity of female rats, no lethal effect was observed
at doses of 2.0, 1.0, 0.5 and 0.25 g/kg bw, but relative weight of liver was
significantly reduced in all experimental groups. In the teratogenic study,
maternal body weight gain and food intake were reduced according to the dose of alum.
There were no differences among all the groups in the numbers of implantations and
resorptions, but fetal weight in alum-administered groups was significantly reduced
compared with control. No external malformation of fetuses was observed in any group.
Skeletal and visceral observations of fetuses indicated that there was no significant
difference in frequency of anomalies between control and experimental groups.
No adverse effect on postnatal growth was observed in 0.32% group,
but the offspring in 10% group showed slow postnatal body weight gain.
From above results, it is concluded that alum possesses no teratogenic effect
in rats fed the diet containing ranging from 0.32 to 10% during the second trimester of gestation.
Calculated for Aluminium potassium bis sulphate anhydrous:
LD0 = 250 - 2000 mg AlK(SO4)2*12 H2O/kg bw = 136 mg/kg bw - 1088 mg /kg bw Aluminium potassium bis sulphate.
NOAEL: 0.32-10% Aluminium potassium bis sulphate*24H2O or AlK(SO4)2*12 H2O in diet - no teratogenic effects in rats.
Calculated for Aluminium potassium bis sulphate anhydrous:
NOAEL: 121 - 4031 mg/kg bw/day Aluminium potassium bis sulphate anhydrous - no teratogenic effects in rats.
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