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EC number: 309-928-3 | CAS number: 101357-30-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- November 1966
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study is not well documented. No GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Number of animals per group 12 instead of 16 minimum; duration of treatment is not clear.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt, sulfurized
- EC Number:
- 309-928-3
- EC Name:
- Silicic acid, aluminum sodium salt, sulfurized
- Cas Number:
- 101357-30-6
- Molecular formula:
- |Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2
- IUPAC Name:
- tetrasodium oxo[(oxoalumanyl)oxy]alumane silanedione trisulfane-1,3-diide oxidandiide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- -Age at study initiation: Female rats of approximately the same age.
-Weight at study initiation: between 300 and 350g
- Diet (e.g. ad libitum): oxoid breeding diet
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Males were placed with respective females overnight and mating was confirmed by the presence of spermatozoo in vaginal smears, and this was designated the first day of pregnancy.
- Duration of treatment / exposure:
- 7 days prior to mating
- Frequency of treatment:
- Every day
- Duration of test:
- The mothers were killed on the 22nd day of pregnancy
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10 mg/kg bw/day
Basis:
nominal conc.
100 ppm in diet
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal conc.
1000 ppm in diet
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
nominal conc.
10000 ppm in diet
- Remarks:
- Doses / Concentrations:
10000 mg/kg bw/day
Basis:
nominal conc.
100000 ppm in diet
- No. of animals per sex per dose:
- 5 groups of 12 animals in each
Group 1: no test material in diet
Group 2: 100 ppm in diet
Group 3: 1000 ppm in diet
Group 4: 10000 ppm in diet
Group 5: 100000 ppm in diet - Control animals:
- yes
Examinations
- Fetal examinations:
- -Litter size
-Weight of live young
-Resorptions
-Malformations
In addition, foetuses from ten of the twelve animals of each group were cleared and stained with alizarin and examined for defects of the skeleton. The foetuses from the remaining two mothers were sent for histopathological examination. The following tissues were specially observed: eye, heart, liver, ossification centres.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There were no maternal deaths.
When fed in the diet of rats in a concentration up to 10000 ppm (1000 mg/kg/day), the test substance had no effects on the growth, blood cellular constituents and haemoglobin or on the main biochemical constituents of the blood and urine. No significant effect on the organ weights.
At higher concentrations 1000 mg/kg bw and 10000 mg/kg bw, there were pathological effects in the kidneys, stomach, intestine and bladder which one would associate with a high and prolonged intake of a siliceous earth.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- Litter size: there was no significant difference between the control and dose level groups.
- Weight of live young: there were no significant differences in the mean weights of the young in the treated and control groups.
- Resorptions: the number of resorptions at each dose level was very low and there was no significant difference between treated and control groups.
- Malformations: no malformations were observed in the control and the top dose level. At 10 mg/kg bw /day dose level one foetus had its hind limbs flexed inwards and another was slightly oedematous. Both these foetuses were from the same mother. At 100 mg/kg bw/day dose level two foetuses from the same mother had all their limbs twisted. At 1000 mg/kg bw/day dose level one foetus had a hernia and another had its limbs slightly twisted.
- Histopathology: an increase in the pericardial space was observed in one foetus from the controls, two foetuses from one animal from the 1000 mg/kg bw/day dose level and three from one animal from the 10000 mg/kg bw/day dose level. No other abnormalities were detected.
The test material has no teratogenic effects at the dose levels from 10 mg/kg bw/day to 1000 mg/kg bw/day.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 000 mg/kg bw/day
- Based on:
- test mat.
- 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:
- The NOAEL maternal toxicity is > 100 mg/kg bw per day
The NOAEL teratogenicity is > 10000 mg/kg bw per day - Executive summary:
The study was performed to assess the teratogenic activity of the test material according to a method similar to OECD guideline 414). It was given an oral administration of the test material mixed in their diet at four different dose levels (10, 100, 1000, 10000 mg/kg bw) to 5 different groups of 12 female rats in each (a total of 60) during 7 days prior to mating. No maternal deaths and no teratogenical effects were observed. Results of the investigations confirm that the test material has not teratogenic activity.
The NOAEL maternal toxicity is > 100 mg/kg bw per day
The NOAEL teratogenicity is > 10000 mg/kg bw per day
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