Registration Dossier
Registration Dossier
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EC number: 217-496-1 | CAS number: 1873-88-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537Escherichia coliWP2 (OECD TG 471) (Sokolowski, 2008).
Cytogenicity in mammalian cells: negative with and without activation in Chinese hamster V79 cells (OECD TG 473) (Hoffman, 2008).
Mutagenicity in mammalian cells: negative with and without activation in mouse lymphoma L5178Y cells (OECD TG 476) (Trenz, 2012).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-28 - 2008-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent: the solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100 without metabolic activation 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- TA98 - 10 µg/plate, TA1537 - 50 µg/plate without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 3 µl/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- TA1535, TA1537, TA98, TA100 - 2.5 µg/plate and WP2 uvrA - 10 µg/plate with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: S9 mix contained glucose-6-phophate and NADP as co-factors, the S9 supernatant was 10% v/v in the S9 mix of which 0.5 ml were added to 2 ml top agar, giving a final concentration of approximately 2% S9.
DURATION
- Preincubation period: 60 minutes at 37ºC
- Exposure duration: Experiment 1 - 72 hours at 37ºC, experiment II - 72 hours at 37ºC + a further 72 hours at 4ºC
SELECTION AGENT: histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- A result is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and WP2 uvrA) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- Statistics:
- No statistical analysis was performed.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
COMPARISON WITH HISTORICAL CONTROL DATA: yes, included in report and all within limits - Conclusions:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 and in compliance with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without activation in the initial plate incorporation assay or the repeat experiment using the preincubation method. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-09 - 2008-05-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- - Name of test material (as cited in study report): 1,1,1,3,5,5,5-Heptamethyltrisiloxane
- Substance type: mono-constituent
- Physical state: colourless liquid
- Analytical purity: 98.9% (GLC)
- Molecular weight: 222.5 g/mol
- Lot/batch No.: 14718HC
- Expiration date of the lot/batch: 04 October 2008
- Stability under test conditions: Not indicated by the sponsor
- Storage condition of test material: At room temperature
- Other: - Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (Minimal Essential Medium) with 10% foetal calf serum (FCS)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Expt 1: 17.6, 35.2, 70.3 µg/ml (- MA); 8.8, 17.6, 35.2, 70.3 µg/ml (+ MA); Expt 2 17.6, 35.2, 70.3 µg/ml (- MA); 8.8, 17.6, 35.2, 281.3, 562.5, 1125 µg/ml (+MA).
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: solvent chosen for solubility properties and its relative non-toxicity to the cell cultures. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 500µg/ml Experiment II, 900 µg/ml Experiment I
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation. Experiment I - 1.4 µg/ml, Experiment II - 2 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: without metabolic activation - 4, 18 and 24 hours, with metabolic activation - 18 and 28 hours
- Expression time (cells in growth medium):
- Fixation time (start of exposure up to fixation or harvest of cells):
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 slides per group, experiment repeated
NUMBER OF CELLS EVALUATED: 100 metaphases per culture
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; other: cell growth inhibition
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
OTHER: ACTIVATION: Phenobarbital/beta-Naphthoflavone induced rat liver S9, with protein content of 28.3 mg/l (pre-test and expt 1) or 31.0 mg/l (expt 2); S9 mix contained glucose-6-phosphate and NADP as co-factors. Final protein concentration in cultures was 0.75 mg/ml, equivalent to approximately 0.4%. - Evaluation criteria:
- The test is considered acceptable if it meets the following criteria: a) The number of structural aberrations found in the solvent controls falls within the range of the laboratory's historical control data: 0.0 - 4.0% aberrant cells, excluding gaps. b) The positive control substances should produce significant increases in the number of cells with structural chromosome aberrations, which are within the range of the laboratory's historical control data.
- Statistics:
- Fisher's exact test
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no effect
- Effects of osmolality: no effect
- Water solubility: phase separation occurred in some of the treated cultures
- Precipitation: precipitation in the form of oily drops was observed after 4 hour treatment with 70.3 µg/ml and above in the presence and absence of S9 mix
RANGE-FINDING/SCREENING STUDIES:
COMPARISON WITH HISTORICAL CONTROL DATA: yes and all acceptable
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Conclusions:
- 1,1,1,3,5,5,5-Heptamethyltrisiloxane has been tested in an in vitro cytogenicity test to OECD 473, in compliance with GLP. No evidence of a test-substance related increase in chromosome aberrations was observed with or without metabolic activation in the initial or repeat experiment using Chinese Hamster V79 cells. It is concluded that the test substance is negative for cytogenicity under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-08-01 - 2011-10-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- With S9 - Exp 1 - 0.1, 0.2, 0.5, 1.25, 2.5, 5.0, 7.5, 10.0 mM Exp 2 - 1, 2, 4, 6, 7, 8, 9, 10 mM
Without S9 Exp 1 - 0.05, 0.1, 0.2, 0.5, 1.25, 2.5, 5.0, 7.5, 9.0, 10.0 mM Exp 2 - 0.1, 0.25, 1.5, 2.5, 3.5, 5.0, 6.0, 7.5, 9.0, 10.0 mM - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: the solvent was compatible with the survival of the cells of the S9 activity. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 200 µg/ml and 300 µg/ml
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/ml
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 µg/ml
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors resulting in a final protein concentration of 0.75 mg/ml in the cultures.
DURATION
- Exposure duration: Short term exposure - 4 hrs, long term exposure -24 hrs
- Expression time (cells in growth medium): 2 days at 37ºC
- Selection time (if incubation with a selection agent): at least 6 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14 days
SELECTION AGENT (mutation assays): TFT (Triflourothymidine)
NUMBER OF REPLICATIONS: experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: growth inhibition - Evaluation criteria:
- The test item is considered mutagenic if the induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 per 10x6 cells or a dose-dependent increase in mutant frequency is detected.
- Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the controls.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with and without metabolic activation
- Cytotoxicity / choice of top concentrations:
- other: variable without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP. No biologically relevant increase in mutation rate was found in mouse lymphoma L5178Y cells with or without metabolic activation in either the initial or the repeat experiment, up to limit and cytotoxic concentrations. The global evaluation factor was not exceeded at any concentration. In addition, colony sizing showed no clastogenic effects in either experiment. The degree toxicity observed was variable, and not dose related. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
Referenceopen allclose all
Results of plate incorporation assay Experiment I; revertants per plate (mean of 3 plates)
[Note, the pre-experiment is reported as Experiment 1, as there were evaluable plates at all concentrations in all strains used.]
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
Solvent control** |
- |
16 |
13 |
22 |
130 |
54 |
Negative control*** |
- |
14 |
12 |
24 |
130 |
47 |
3 |
- |
11 |
14 |
21 |
138 |
50 |
10 |
- |
11 |
14 |
29 |
130 |
46 |
33 |
- |
11 |
12 |
21 |
122 |
51 |
100 |
- |
9 |
14 |
25 |
120 |
45 |
333 |
- |
16 |
18 |
21 |
136 |
52 |
1000 |
- |
15 |
10 |
24 |
138 |
52 |
2500 |
- |
15 |
13 |
22 |
137 |
59 |
5000 |
- |
13 |
8 |
26 |
158 |
62 |
Positive control |
- |
1935 |
78 |
281 |
2196 |
1314 |
Solvent control** |
+ |
15 |
16 |
33 |
172 |
64 |
Negative control*** |
+ |
18 |
13 |
37 |
154 |
49 |
3 |
+ |
17 |
16 |
33 |
149 |
64 |
10 |
+ |
17 |
15 |
35 |
165 |
57 |
33 |
+ |
17 |
16 |
34 |
177 |
65 |
100 |
+ |
18 |
17 |
38 |
165 |
61 |
333 |
+ |
18 |
18 |
35 |
161 |
64 |
1000 |
+ |
12* |
15* |
29* |
157* |
55* |
2500 |
+ |
11* |
13* |
25* |
156* |
55* |
5000 |
+ |
12* |
11* |
26* |
148* |
55* |
Positive control |
+ |
234 |
123 |
998 |
1334 |
231 |
* non-interfering precipitate
** with acetone
*** Untreated
Results of preincubation assay, Experiment 2; revertants per plate (mean of 3 plates)
Dose level µg/plate |
Metabolic activation |
Mean revertant colony counts |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
Solvent control** |
- |
12 |
12 |
30 |
133 |
37 |
Negative control*** |
- |
14 |
17 |
30 |
120 |
44 |
33 |
- |
13 |
13 |
23 |
136 |
42 |
100 |
- |
14 |
11 |
23 |
135 |
45 |
333 |
- |
15 |
13 |
31 |
125 |
46 |
1000 |
- |
15 |
12 |
26 |
133 |
43 |
2500 |
- |
15 |
11 |
21 |
118 |
39 |
5000 |
- |
14 |
10 |
31 |
125 |
38 |
Positive control |
- |
2143 |
99 |
335 |
1941 |
901 |
Solvent control** |
+ |
19 |
15 |
34 |
121 |
60 |
Negative control*** |
+ |
16 |
18 |
33 |
156 |
49 |
33 |
+ |
18 |
17 |
31 |
142 |
52 |
100 |
+ |
15 |
19 |
33 |
142 |
52 |
333 |
+ |
16 |
19 |
36 |
137 |
60 |
1000 |
+ |
18* |
16* |
30* |
129 |
60 |
2500 |
+ |
15* |
16* |
30* |
135* |
56* |
5000 |
+ |
17* |
14* |
30* |
154* |
49* |
Positive control |
+ |
307 |
195 |
1206 |
863 |
349 |
* non-interfering precipitate
** with acetone
*** Untreated
Summary of results of chromosome aberration study – Experiment 1
Exposure period (hrs) |
+/- metabolic activation |
Prepar-ation interval |
Dose level µg/ml |
% Polyploidy cells |
Cell numbers in % of control |
Mitotic indices in % of control |
% Aberrant cells |
||
incl gaps |
excl gaps |
with exchanges |
|||||||
4 |
- |
18 |
Solvent control |
2.0 |
100.0 |
100.0 |
1.5 |
1.5 |
1.0 |
4 |
- |
18 |
17.6 |
2.4 |
96.1 |
107.2 |
2.0 |
1.0 |
0.0 |
4 |
- |
18 |
35.2 |
2.0 |
93.4 |
90.6 |
2.0 |
1.0 |
0.0 |
4 |
- |
18 |
70.3P |
2.2 |
92.7 |
108.6 |
3.0 |
1.5 |
0.0 |
4 |
- |
18 |
Positive control |
2.4 |
n.t. |
101.1 |
13.0 |
12.0 |
2.5 |
4 |
+ |
18 |
Solvent control |
3.6 |
100.0 |
100.0 |
1.0 |
1.0 |
0.0 |
4 |
+ |
18 |
8.8 |
2.4 |
97.7 |
95.4 |
2.0 |
1.5 |
0.5 |
4 |
+ |
18 |
17.6 |
3.1 |
94.6 |
81.3 |
0.5 |
0.5 |
0.0 |
4 |
+ |
18 |
35.2P |
2.5 |
124.7 |
90.8 |
2.0 |
1.5 |
0.0 |
4 |
+ |
18 |
Positive control |
2.9 |
n.t. |
81.7 |
12.0 |
11.0 |
3.0 |
Summary of results of chromosome aberration study – Experiment II
Exposure period (hrs) |
+/- metabolic activation |
Prepar-ation interval |
Dose level µg/ml |
% Polyploidy cells |
Cell numbers in % of control |
Mitotic indices in % of control |
% Aberrant cells |
||
incl gaps |
excl gaps |
with exchanges |
|||||||
18 |
- |
18 |
Solvent control |
2.9 |
100.0 |
100.0 |
2.0 |
1.5 |
0.5 |
18 |
- |
18 |
17.6 |
2.7 |
86.1 |
110.1 |
1.0 |
1.0 |
0.0 |
18 |
- |
18 |
35.2 |
3.0 |
86.4 |
109.5 |
3.5 |
2.5 |
0.0 |
18 |
- |
18 |
70.3P |
2.5 |
91.9 |
104.7 |
2.0 |
2.0 |
0.0 |
18 |
- |
18 |
Positive control |
2.0 |
n.t. |
84.9 |
18.5 |
15.0 |
7.5 |
28 |
- |
28 |
Solvent control |
2.9 |
100.0 |
100.0 |
1.0 |
1.0 |
0.0 |
28 |
- |
28 |
35.2 |
2.5 |
99.9 |
107.3 |
2.5 |
2.5 |
0.0 |
28 |
- |
28 |
70.3P |
3.1 |
95.4 |
104.4 |
1.0 |
0.5 |
0.0 |
28 |
- |
28 |
Positive control |
2.4 |
n.t. |
90.8 |
32.0 |
32.0 |
15.0 |
4 |
+ |
28 |
Solvent control |
2.3 |
100.0** |
100.0 |
1.5 |
1.5 |
0.0 |
4 |
+ |
28 |
8.8 |
2.4 |
79.6** |
92.5 |
3.0 |
2.0 |
0.0 |
4 |
+ |
28 |
17.6 |
3.2 |
71.5** |
110.9 |
1.5 |
1.5 |
0.0 |
4 |
+ |
28 |
35.2P |
2.4 |
76.3** |
105.2 |
2.0 |
0.5 |
0.0 |
4 |
+ |
28 |
281.3P |
2.5 |
65.3** |
103.7 |
2.0 |
1.5 |
0.0 |
4 |
+ |
28 |
562.5P |
2.4 |
108.3** |
106.7 |
0.5 |
0.5 |
0.0 |
4 |
+ |
28 |
1125.0P |
2.8 |
93.3** |
101.1 |
0.5 |
0.5 |
0.0 |
4 |
+ |
28 |
Positive control |
2.2 |
n.t. |
92.1 |
14.0 |
13.0 |
1.0 |
** = Cell count on spread slides P = Precipitation occurred
n.t. = not tested
Summary tables of Experiment 1 and 2 without metabolic activation
Treatment (mM) |
RTG (%) |
MF (mutants/106cells |
IMF (mutants/106cells) |
Precipitate |
|
-S9 |
-S9 |
-S9 |
-S9 |
Negative control |
111.7 |
74.2 |
/ |
- |
Negative control |
110.7 |
/ |
- |
|
Solvent control |
100.0 |
84.2 |
/ |
- |
Solvent control |
/ |
- |
||
0.05 |
85.4 |
82.5 |
-1.7 |
- |
0.1 |
67.4 |
84.4 |
0.3 |
- |
0.2 |
10.5 |
117.3 |
33.2 |
- |
0.5 |
9.3 |
135.8 |
51.7 |
- |
1.25 |
100.6 |
68.4 |
-15.7 |
- |
2.5 |
25.0 |
128.5 |
44.3 |
- |
5.0 |
27.0 |
64.7 |
-19.5 |
- |
7.5 |
66.2 |
93.9 |
9.8 |
- |
9.0 |
88.5 |
98.5 |
14.3 |
- |
10.0 |
89.7 |
97.5 |
13.4 |
- |
Positive control 1 |
73.3 |
530.0 |
445.9 |
- |
Positive control 2 |
56.5 |
537.7 |
453.6 |
- |
Treatment (mM) |
RTG (%) |
MF (mutants/106cells |
IMF (mutants/106cells) |
Precipitate |
|
-S9 |
-S9 |
-S9 |
-S9 |
Negative control |
118.7 |
94.9 |
/ |
- |
Negative control |
120.6 |
/ |
- |
|
Solvent control |
100.0 |
67.5 |
/ |
- |
Solvent control |
/ |
- |
||
0.1 |
89.7 |
118.8 |
51.2 |
- |
0.25 |
109.5 |
83.2 |
15.7 |
- |
1.5 |
112.8 |
71.5 |
4.0 |
- |
2.5 |
111.2 |
70.5 |
2.9 |
- |
3.5 |
7.5 |
111.9 |
44.3 |
- |
5.0 |
86.2 |
86.9 |
19.4 |
- |
6.0 |
79.1 |
116.0 |
48.4 |
- |
7.5 |
110.2 |
74.1 |
6.6 |
- |
9.0 |
96.9 |
56.1 |
-11.5 |
- |
10.0 |
110.9 |
49.0 |
-18.6 |
- |
Positive control 1 |
41.4 |
2356.5 |
2288.9 |
- |
Positive control 2 |
34.8 |
1546.6 |
1479.1 |
- |
Summary tables of Experiment 1 and 2 with metabolic activation
Treatment (mM) |
RTG (%) |
MF (mutants/106cells |
IMF (mutants/106cells) |
Precipitate |
|
+S9 |
+S9 |
+S9 |
+S9 |
Negative control |
106.6 |
106.8 |
/ |
- |
Negative control |
113.4 |
/ |
- |
|
Solvent control |
100.0 |
108.9 |
/ |
- |
Solvent control |
/ |
- |
||
0.1 |
96.1 |
123.8 |
14.9 |
- |
0.2 |
100.5 |
132.6 |
23.8 |
- |
0.5 |
102.4 |
142.9 |
34.0 |
- |
1.25 |
111.0 |
113.0 |
4.1 |
- |
2.5 |
107.6 |
87.9 |
-21.0 |
- |
5.0 |
98.6 |
143.5 |
34.6 |
- |
7.5 |
98.0 |
140.8 |
31.9 |
- |
10.0 |
99.4 |
129.0 |
20.1 |
- |
Positive control 1 |
61.4 |
711.7 |
602.8 |
- |
Treatment (mM) |
RTG (%) |
MF (mutants/106cells |
IMF (mutants/106cells) |
Precipitate |
Negative control |
100.9 |
73.5 |
/ |
- |
Negative control |
102.5 |
/ |
- |
|
Solvent control |
100.0 |
91.1 |
/ |
- |
Solvent control |
/ |
- |
||
1 |
108.1 |
84.7 |
-6.4 |
- |
2 |
111.8 |
89.4 |
-1.7 |
- |
4 |
107.3 |
81.4 |
-9.7 |
- |
6 |
112.7 |
55.8 |
-35.3 |
- |
7 |
104.4 |
101.9 |
10.8 |
- |
8 |
100.7 |
72.2 |
-18.9 |
- |
9 |
103.3 |
79.5 |
-11.6 |
- |
10 |
124.8 |
83.4 |
-7.7 |
- |
Positive control 1 |
81.9 |
613.1 |
522.1 |
- |
RTG = Relative total growth
MF = Mutant frequency
IMF = Induced mutant frequency
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
1,1,1,3,5,5,5 -Heptamethyltrisiloxane (H-L3) has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 and in compliance with GLP (Sokolowski, 2008). No evidence of a test-substance related increase in the number of revertants was observed with or without activation in the initial plate incorporation assay or the repeat experiment using the preincubation method. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
H-L3 has been tested in an in vitro cytogenicity test to OECD 473, in compliance with GLP (Hoffman, 2008). No evidence of a test-substance related increase in chromosome aberrations was observed with or without metabolic activation in the initial or repeat experiment using Chinese Hamster V79 cells. It is concluded that the test substance is negative for cytogenicity under the conditions of the test.
Information is available for H-L3 from an in vitro study for mutagenicity to mammalian cells conducted according to OECD TG 476 and in compliance with GLP (Trenz, 2012). No evidence for test-substance induced increase in mutant factor was observed when H-L3 was tested in a reliable study conducted according to OECD TG 476 and in compliance with GLP. No biologically relevant increase in mutation rate was found in mouse lymphoma L5178Y cells with or without metabolic activation in either the initial or the repeat experiment, up to limit and cytotoxic concentrations. The global evaluation factor was not exceeded at any concentration. In addition, colony sizing showed no clastogenic effects in either experiment. The degree toxicity observed was variable, and not dose related. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
In vivo testing is not required as the results of the in vitro assays were all negative.
Justification for classification or non-classification
Based on the available in vitro and in vivo genotoxicity data, H-L3 is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
