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EC number: 246-467-6 | CAS number: 24801-88-5
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987-12-15 to 1988-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- some details not included
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3-aminopropyltriethoxysilane
- EC Number:
- 213-048-4
- EC Name:
- 3-aminopropyltriethoxysilane
- Cas Number:
- 919-30-2
- Molecular formula:
- C9H23NO3Si
- IUPAC Name:
- 3-triethoxysilylpropan-1-amine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Rivers Laboratories
- Age at study initiation: Five weeks
- Assigned to test groups randomly: [yes, by computer generated randomization]
- Housing: Shoe-box type plastic cages (30 x 20 x 12.5 cm)
- Diet (e.g. ad libitum): Agway PROLAB (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 to 6 days prior to dosing
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: sponsor indicated the sample reacts with water - Details on exposure:
- Intraperitoneal injection
- Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- single dose
- Post exposure period:
- 30, 48 and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
90, 56 and 28 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males and 5 females per dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: IP injection
- Doses / concentrations: 0.3 mg/kg
Examinations
- Tissues and cell types examined:
- Blood
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Pre toxicity study (tested to find LD50 using 160, 128 and 102 mg/kg; Doses calculated using this value)
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Blood samples taken 30, 48, and 72 hours after injection
DETAILS OF SLIDE PREPARATION: 2 blood smear slides prepared for each animal per sampling time
METHOD OF ANALYSIS: A minimum of 1000 polychromatic erythrocytes were examined microscopically for each animal per sample time. - Evaluation criteria:
- A positive result in the micronucleus test was concluded if at least one statistically significant (p ≤ 0.01) increase above the vehicle control was observed with an indication of a dose-related effect of treatment.
- Statistics:
- Statistical significance determined using Fisher's Exact Test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- > 112 mg/kg; no effects in bone marrow
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range in range finding study: 160, 128 and 102 mg/kg;
- Solubility: no information
- Clinical signs of toxicity in test animals: lethality at 160, and 128 mg/kg, no clinical observations made during study
- Rationale for exposure: 25, 50 and 80% LD50 (28, 56 and 90 mg/kg bw)
- Harvest times: 30, 48 and 72 hours
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): negative
- Ratio of PCE/NCE (for Micronucleus assay): not affected by test substance
- Appropriateness of dose levels and route: appropriate dose levels and route
- Statistical evaluation: Analysis of variance
Any other information on results incl. tables
Analysis of variance testing indicated significant sex-related differences in the incidence of micronuclei so data were analysed and reported separately. No statistically significant increases in any treatment group sampled at 30 and 72 hours. Statistically significant increases were observed with female mice sampled at 48 hours, but these were the result of an unusually low value in the vehicle control group compared with historical values, and so were not considered to be of biological significance. The positive control group produced highly significant increases in numbers of micronuclei. The vehicle control values were low and within an acceptable range.
Table 1:Results of in vivo micronucleus test with MALE Swiss-Webster mice (30 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
30 |
30 |
30 |
30 |
30 |
|
Number of erythrocytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
10,000 |
10,000 |
10,000 |
10,000 |
10,000 |
|
polychromatic with micronuclei |
13 |
159 |
16 |
10 |
9 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
22.6 |
20.2 |
24 |
26.6 |
24.4 |
polychromatic with micronuclei / normochromatic |
2.6 |
31.8 |
3.2 |
2 |
1.8 |
Table 2:Results of in vivo micronucleus test with FEMALE Swiss-Webster mice (30 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
30 |
30 |
30 |
30 |
30 |
|
Number of erythro-cytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
10,000 |
10,000 |
10,000 |
10,000 |
10,000 |
|
polychromatic with micronuclei |
5 |
86 |
13 |
9 |
8 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
25.6 |
26.2 |
25.8 |
38.6 |
25.8 |
polychromatic with micronuclei / normochromatic |
1 |
17.2 |
2.6 |
1.8 |
1.6 |
Table 3:Results of in vivo micronucleus test with MALE Swiss-Webster mice (48 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
48 |
48 |
48 |
48 |
48 |
|
Number of erythro-cytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
5,000 |
5,000 |
5,000 |
5,000 |
5,000 |
|
polychromatic with micronuclei |
15 |
Not evaluated |
23 |
13 |
15 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
31.4 |
Not evaluated |
27.2 |
31 |
29.4 |
polychromatic with micronuclei / normochromatic |
3 |
Not evaluated |
4.6 |
2.6 |
3 |
Table 4:Results of in vivo micronucleus test with FEMALE Swiss-Webster mice (48 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
48 |
48 |
48 |
48 |
48 |
|
Number of erythro-cytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
5,000 |
5,000 |
5,000 |
5,000 |
5,000 |
|
polychromatic with micronuclei |
3 |
Not evaluated |
10 |
11 |
10 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
31.2 |
Not evaluated |
24 |
31.2 |
21.8 |
polychromatic with micronuclei / normochromatic |
0.6 |
Not evaluated |
2 |
2.2 |
2 |
Table 5:Results of in vivo micronucleus test with MALE Swiss-Webster mice (72 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
72 |
72 |
72 |
72 |
72 |
|
Number of erythro-cytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
5,000 |
5,000 |
5,000 |
5,000 |
5,000 |
|
polychromatic with micronuclei |
15 |
Not evaluated |
14 |
6 |
12 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
26 |
Not evaluated |
33 |
30.6 |
27.6 |
polychromatic with micronuclei / normochromatic |
3 |
Not evaluated |
2.8 |
1.2 |
2.4 |
Table : Results of in vivo micronucleus test with FEMALE Swiss-Webster mice (72 hours)
|
Solvent Control |
Positive Control |
Low dose 28 mg/kg |
Mid dose 56 mg/kg |
High dose 90 mg/kg |
|
Number of cells evaluated |
1000 |
1000 |
1000 |
1000 |
1000 |
|
Sampling time (h) |
72 |
72 |
72 |
72 |
72 |
|
Number of erythro-cytes |
normochromatic |
- |
- |
- |
- |
- |
polychromatic |
5,000 |
5,000 |
5,000 |
5,000 |
5,000 |
|
polychromatic with micronuclei |
8 |
Not evaluated |
1 |
3 |
5 |
|
Ratio of erythrocytes |
polychromatic / normochromatic |
25.2 |
Not evaluated |
26.6 |
27.2 |
26.6 |
polychromatic with micronuclei / normochromatic |
1.6 |
Not evaluated |
0.2 |
0.6 |
1 |
Applicant's summary and conclusion
- Conclusions:
- 3-Aminopropyl(triethoxy)silane (CAS No. 919-30-2) has been tested in a reliable mouse micronucleus assay according to a protocol that is similar to OECD TG 474 and in compliance with GLP. No treatment related increases in numbers of micronuclei in polychromatic erythrocytes in Swiss-Webster mice were observed. Relatively high dose levels of 3-aminopropyl(triethoxy)silane were tested up to 80% of the LD50 with no indication of a positive induction of micronuclei. 3-Aminopropyl(triethoxy)silane was considered to be inactive as a clastogenic agent under the statistical criteria used. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of the test.
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