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EC number: 215-684-8 | CAS number: 1344-00-9
- 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
Carcinogenicity
Administrative data
Description of key information
No carcinogenic potential was observed with Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) in a whole live study in rats after intrapleural administration. This study concluded that NAS is not carcinogenic in rats in that it does not induce mesotheliomas following intrapleural injection.
The same result was obtained in long-term feeding studies with structurally related silicon dioxide in mice and rats.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- Group sizes smaller than recommended: effectively 20/sex/dose for terminal sacrifice; recommended 50 (note: Sufficient biostatistical power can never be achieved for substances that have no or a very low cancerogenic potential.)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Funabashifarm Animal Co. Ltd. Japan
- Age at study initiation: 3 weeks
- Weight at study initiation: 117 - 150 g (male rats); 92 - 126 g (female rats)
- Fasting period before study:
- Housing: 2 rats/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-1
- Humidity (%): 50 +-10 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 10 dark / 14 light - Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 103 weeks with interim kill after 6 and 12 months (10 animals each)
- Frequency of treatment:
- daily
- Post exposure period:
- none
- Remarks:
- Doses / Concentrations:
1.25, 2.5 and 5 %
Basis:
nominal in diet - No. of animals per sex per dose:
- 40
- Control animals:
- yes
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Fisher´s exact test and Cochran-Armitage test for trend
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Result (carcinogenicity): negative:
The tumour responses in the silica-fed rats were not statistically significantly different from the controls (Fisher´s exact test and Cochran-Armitage test for trend) (see also: IARC 1997, p. 171). - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested)
- Effect level:
- 5 other: % in the diet
- Sex:
- male/female
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested: 5 % in the diet)
- Effect level:
- ca. 1 800 - ca. 3 000 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Specific silica intake decreased over time during growth and aging in relation to the relative reduction in food intake (see Report, Tab. 7)
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested: 5 % in the diet)
- Effect level:
- ca. 1 800 - ca. 3 200 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Specific silica intake decreased over time during growth and aging in relation to the relative reduction in food intake (see Report, Tab. 8)
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- Group sizes smaller than recommended: effectively 20/sex/dose for terminal sacrifice; recommended 50 (note: Sufficient biostatistical power can never be achieved for substances that have no or a very low cancerogenic potential.)
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Funabashifarm Animal Co. Ltd. Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: 21 - 27.3 g (male mice); 16 - 19.9 g (female mice)
- Fasting period before study:
- Housing: 5 mice/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-1
- Humidity (%): 50 +-10 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 10 dark / 14 light - Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 93 weeks with interim kill after 6 and 12 months, 10 animals each
- Frequency of treatment:
- daily
- Post exposure period:
- none
- Remarks:
- Doses / Concentrations:
1.25, 2.5 and 5 %
Basis:
nominal conc. - No. of animals per sex per dose:
- 40
- Control animals:
- yes
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Fisher´s exact test and Cochran-Armitage test for trend
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- 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:
- Result (carcinogenicity): negative:
The tumour responses in the silica-fed mice were not statistically significantly different from the controls (Fisher´s exact test and Cochran-Armitage test for trend) (see also: IARC 1997, p. 171). - Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested)
- Effect level:
- 5 other: % in the diet
- Sex:
- male/female
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested: 5 % in the diet)
- Effect level:
- ca. 5 000 - ca. 7 000 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Specific silica intake decreased over time during body-weight gain in relation to the relative reduction in food intake (see Report, Tab. 2)
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (highest dose level tested: 5 % in the diet)
- Effect level:
- ca. 4 000 - ca. 13 000 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Specific silica intake decreased over time during body-weight gain in relation to the relative reduction in food intake (see Report, Tab. 3)
- Remarks on result:
- other:
- Remarks:
- Effect type: other: carcinogenicity and toxicity (migrated information)
Referenceopen allclose all
The mean cumulative intake was 143.46, 279.55 and 581.18
g/rat in males
and 107.25, 205,02 and 435.33 g/rat in females, respectively.
(Note: Misprint for substance uptake by males, 2.5 %, in Tab. 7: 179.55 must read 279.55 g/rat.)
The average doses of the male and female 5%-groups were approx. 1800 to 2000 mg/(kg bw*d)
after week 15 of the study start, while they were distinctly higher in the juvenile phase of life
(comp. Report, Tab. 7 and 8).
Specific silica intake decreased over time during growth and aging in relation to the relative reduction
in food intake. A reasonable average of 2000 mg/(kg bw*d) is estimated from the experimental data.
This estimate relates to a mean body weight of 400 g and 300 g for males and females, respectively
(see Report, Tab. 7 and 8), which agrees fairly well with the growth curves (comp. Report, Fig. 5 and 6) .
No significant variations in survival rats were observed in males, while the female survival rats
were decreased but not statistic significant different from the control group. In body weight, food intake
or in hematology and clinical chemistry parameters no relevant changes were seen. Lower liver weights
were
noted from 12 to 24 months in the 2.5 and 5 % female dose group.
In histopathological examination the tumour incidence was the greatest in testes,
mammmary gland
(incidence in the controls higher than in the treatment groups) and prepuce (males) and mammary
gland and clitoris
(incidence in the controls higher
than in the treatment groups) in females.
(see also IARC 1997)
The mean cumulative intake after 93 weeks was 38.45, 79.78 and 160 g/mouse in males and 37.02, 72.46 and 157.59 g/mouse in females, respectively.
The average doses of the male and female 5%-groups were approx. 5800 and 4500 mg/(kg bw*d) after week 15 - 20 of the study start, while they were distinctly higher in the juvenile phase of life, in particular in the female group (comp. Report, Tab. 2 and 3).
Specific silica intake decreased over time during growth and aging in relation to the relative reduction in food intake. A reasonable average of 5800 and 4500 mg/(kg bw*d) is estimated from the experimental data (see Report, Tab. 2 and 3). These estimates largely relate to a mean body weight of 42 g and 45 g for males and females, respectively, from week 15 through 93, which agrees fairly well with the growth curves (comp. Report, Fig. 1 and 2).
In the 2.5 and 5 % groups the food consumption increased, but this was accompanied by a decreased body-weight gain in the 5-% group from week 15 through 50 (males, <0.01) and from week 30 through 50 (females, p<0.05).
No differences in mean body weights were found in the second half of the investigation (see Report Fig. 1 and 2 / Tab. 2 and 3).
No significant difference in survival rats or behaviour was observed.
No dose-related alteration in hematologic parameters was evident.
None of the changes in organ weights were sex- or dose-related.
At the histopathological examination, tumors were found in the hematopoietic organs, particularly malignant lymphoma/leukemia, which occurred in 7/20 (38 %) in the female groups of the 2.5 % dose group.
The results of the Cochran-Armitage test for positive dose-related trends in the incidence of tumors were not significant.
Females: In the lungs, the frequency of adenocarcinomas was 1/16 (6.25 %) for the control, 1/19 (5.3 %) for the 1.25-%, 0/20 for the 2.5-%, and
1/20 (5 %) for the 5-% dosage groups of females (no adenomas).
Males: In the lungs, the frequency of adenocarcinomas was 1/16 (6.25) for the control, 2/17 (11.8 %) for the 1.25-%, 3/14 (21.4 %) for the 2.5-%,
and 3/16 (18.8 %) for the 5-% dosage groups of males.
In the liver, the correlation of hyperplastic nodules/hepatocellular carcinoma/hemangioma/fibrosarcoma in the treated groups, as compared with
the control group was relatively low.
Non-neoplastic lesions were observed in the subcutis, lungs, kidneys, and liver in the treated groups.
But these were considered to be of no toxicological significance.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- other: mice and rats
- Quality of whole database:
- reliability 2
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
As no carcinogenic potential was observed, there is no need for classification
Additional information
Negative findings in a rat carcinogenicity model after comparative intrapleural treatment with various types of materials (including Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS)) [Chamberlain 1999] and the absence of a mutagenic potential underline that Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) is not cancerogenic.
Negative results were also found after long-term oral administration of the structure-analogous synthetic amorphous silica (SAS) (up to 5 % in the diet given to rats and mice, corresponding to average daily doses of 2000 mg/kg bw in rats and 4500 to 5800 mg/kg bw in mice, female and male, respectively) [Takizawa et al. 1988].
In the synopsis of all studies, it is concluded that there is no evidence of a carcinogenic potential arising from the ingestion of synthetic amorphous Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS).
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