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EC number: 214-711-0 | CAS number: 1189-08-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Auto flammability
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979-11-26 to 1980-03-24
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Relevant methodological deficiencies: the independent repeats were not consistent; results confunded by precipitation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1-methyltrimethylene dimethacrylate
- EC Number:
- 214-711-0
- EC Name:
- 1-methyltrimethylene dimethacrylate
- Cas Number:
- 1189-08-8
- Molecular formula:
- C12H18O4
- IUPAC Name:
- 4-[(2-methylprop-2-enoyl)oxy]butan-2-yl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- - chemical name: 1,3-Butanediol dimethacrylate
Constituent 1
Method
- Target gene:
- thymidine kinase (TK)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
growth medium: Fisher's mouse leukemia medium, supplemented with L-glutamine, sodium pyruvate and 10% horse serum;
cloning medium: growth medium + 0.35% agar
selection medium: cloning medium + 100 µg/mL BrdU or 3 µg/mL TFT
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 1.95 nL/mL to 1.0 µL/mL in twofold dilution steps
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test substance was immiscible with water at 100 µL/mL, but soluble in DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: dimethylnitrosamine
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 h
- Expression time (cells in growth medium): 2-3 d
- Selection time (if incubation with a selection agent): 10 d
- Fixation time (start of exposure up to fixation or harvest of cells): 12-13 d
SELECTION AGENT (mutation assays): 3 µg/mL trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: 1; seeded in triplicates for selection
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency / relative growth - Evaluation criteria:
- A test substance is considered to be mutagenic if:
- for any treatment the mutant frequency exceeds 150% of the concurrent background control by at least 1E-06 (= minimum criterion)
- a concentration-related or toxicity-related increase in mutant frequency is observed
- an increase of 2 times the minimum criterion is observed in a single concentration near the highest testable concentration
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
The test substance separated from the culture medium to form suspended globules at concentrations of 250 nL/mL and higher; in the presence of S9 mix increased cloudiness was observed at 62.5 nL/mL and higher
RANGE-FINDING/SCREENING STUDIES:
in a preliminary test for cytotoxicity treatment with 125 nL/mL reduced the cell growth after 24 h, 250 nL/mL were almost completely lethal
Any other information on results incl. tables
Rel. Suspension growth [%] |
Rel. cloning efficiency[%] |
percent rel. Growth[%] |
mutant frequency x10E-06 |
evaluation |
||
Experiment 1, without metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
33.1 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
24.2 |
- |
|
untreated control |
60.9 |
84.1 |
51.2 |
50.0 |
- |
|
Positive control (EMS) |
42.6 |
36.3 |
15.5 |
768.5 |
+ |
|
test item [nL/mL] |
15.6 |
31.5 |
91.0 |
28.7 |
23.8 |
- |
31.3 |
36.4 |
124.5 |
45.3 |
22.6 |
- |
|
62.5 |
63.3 |
72.2 |
45.7 |
44.1 |
- |
|
125 |
57.5 |
61.2 |
35.2 |
46.0 |
- |
|
250 |
15.5 |
98.0 |
15.2 |
25.4 |
- |
|
Experiment 1, with metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
26.9 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
34.3 |
- |
|
untreated control |
139.9 |
76.0 |
106.3 |
35.4 |
- |
|
Positive control (DMN) |
60.9 |
41.0 |
24.9 |
248.6 |
+ |
|
test item [nL/mL] |
3.9 |
63.6 |
72.2 |
46.2 |
40.1 |
- |
31.3 |
145.7 |
83.0 |
121.0 |
41.3 |
- |
|
62.5 |
112.7 |
99.3 |
111.6 |
35.7 |
- |
|
125 |
58.7 |
97.4 |
57.2 |
47.0 |
- |
|
250 |
68.4 |
89.7 |
43.4 |
47.7 |
- |
|
Experiment 2, with metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
24.2 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
21.2 |
- |
|
untreated control |
102.9 |
82.0 |
84.4 |
28.3 |
- |
|
Positive control (DMN) |
35.2 |
20.6 |
7.3 |
194.5 |
+ |
|
test item [nL/mL] |
250 |
52.4 |
78.7 |
41.2 |
31.0 |
- |
300 |
44.0 |
89.9 |
39.5 |
32.9 |
- |
|
400 |
42.6 |
89.9 |
38.3 |
36.7 |
- |
|
400 |
48.1 |
96.3 |
46.3 |
40.9 |
- |
|
500 |
30.3 |
77.6 |
23.5 |
48.8 |
+ |
|
500 |
39.8 |
67.4 |
26.8 |
51.7 |
+ |
|
600 |
18.9 |
86.9 |
16.5 |
59.5 |
+ |
|
Experiment 3, with metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
14.6 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
20.1 |
- |
|
untreated control |
127.0 |
86.7 |
112.7 |
16.8 |
- |
|
Positive control (DMN) |
45.8 |
10.1 |
4.6 |
317.2 |
+ |
|
test item [nL/mL] |
400 |
24.8 |
67.6 |
16.8 |
45.6 |
+ |
400 |
43.2 |
86.7 |
37.5 |
32.0 |
- |
|
500 |
50.8 |
88.4 |
44.2 |
25.5 |
- |
|
500 |
38.0 |
54.4 |
20.7 |
49.7 |
+ |
|
600 |
26.0 |
49.6 |
12.9 |
100.0 |
+ |
|
Experiment 4, with metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
18.9 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
15.4 |
- |
|
untreated control |
89.0 |
84.6 |
75.3 |
27.2 |
- |
|
Positive control (DMN) |
42.0 |
16.4 |
6.9 |
175.0 |
+ |
|
test item [nL/mL] |
400 |
24.9 |
46.4 |
11.6 |
62.8 |
+ |
400 |
18.4 |
46.2 |
8.3 |
71.8 |
+ |
|
500 |
17.0 |
27.5 |
4.7 |
94.0 |
+ |
|
600 |
6.2 |
16.8 |
1.0 |
120.0 |
+ |
|
Experiment 5, with metabolic activation |
||||||
solvent control |
100.0 |
100.0 |
100.0 |
34.0 |
- |
|
solvent control |
100.0 |
100.0 |
100.0 |
17.8 |
- |
|
untreated control |
119.2 |
38.1 |
105.0 |
19.2 |
- |
|
Positive control (DMN) |
27.5 |
35.0 |
9.6 |
244.8 |
+ |
|
test item [nL/mL] |
62.5 |
32.6 |
81.3 |
26.5 |
73.3 |
+ |
250 |
17.3 |
52.7 |
9.1 |
222.1 |
+ |
|
350 |
9.7 |
26.1 |
2.5 |
488.8 |
+ |
|
400 |
8.7 |
28.9 |
2.6 |
405.1 |
+ |
|
450 |
13.1 |
34.6 |
4.5 |
318.6 |
+ |
|
500 |
3.9 |
10.0 |
1.2 |
618.4 |
+ |
|
550 |
7.9 |
39.0 |
3.1 |
347.4 |
+ |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation
1,3-BDDMA was mutagenic with metabolic activation and not mutagenic without metabolic activation in the mouse lymphoma L5178Y test system under the experimental conditions described in this study. However, precipitation starting from 62.5 nL/mL and higher with metabolic activation and/or separation of the test substance from the culture medium to form suspended globules at 250 nL/mL was reported. It cannot be excluded that different local concentrations due to not completely dissolved test substance were leading to unreproducible results regarding cytotoxicity and mutant frequency. Thus, this test is considered not be not reliable. - Executive summary:
In a mammalian cell gene mutation assay equivalent to OECD guideline 476 (thymidine kinase (TK)), L5178Y mouse lymphoma cells cultured in vitro were exposed to 1,3-BDDMA in DMSO in the following concentrations:
Experiment 1
Without metabolic activation: 15.6, 31.3, 62.5, 125 and 250 nL/mL
With metabolic activation: 3.9, 31.3, 62.5, 125 and 250 nL/mL
Experiment 2
With metabolic activation: 250, 300, 400, 500, 600 nL/mL
Experiment 3
With metabolic activation: 400, 500, 600 nL/mL
Experiment 4
With metabolic activation: 400, 500, 600 nL/mL
Experiment 5
With metabolic activation: 62.5, 250, 350, 400, 450, 500, 550 nL/mL
1,3-BDDMA was tested up to cytotoxic concentrations. Positive controls induced the appropriate response.
No increase in mutant frequency was observed without metabolic activation. As in the first experiment with metabolic activation, no sufficient cytotoxicity was achieved, higher concentrations have been tested.
In the second experiment mutant frequencies were elevated in cultures exposed to 500 and 600 nL/mL, however mutant frequencies induced by the positive control in this experiment was low.
In the third experiment, mutant frequencies were elevated in cultures treated with 400, 500 and 600 nL/mL. As the increase was only small at 400 and 500 nL/mL, further tests have been conducted.
In the forth experiment mutant frequencies were elevated in cultures treated with 400, 500 and 600 nL/mL. All treatments were also highly toxic and resulted in depressed cloning efficiencies.
In the fifth experiment all concentrations starting from 62.5 nL/mL resulted in increased mutant frequencies. But concentrations of 250 nL/mL and higher were highly toxic.
There was evidence of induced mutant colonies over background with metabolic activation.
However, precipitation starting from 62.5 nL/mL and higher with metabolic activation and/or separation of the test substance from the culture medium to form suspended globules at 250 nL/mL was reported.
It cannot be excluded that different local concentrations due to not completely dissolved test substance were leading to unreproducible results regarding cytotoxicity and mutant frequency. Thus, this test is considered not be not reliable.
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