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EC number: 219-143-7 | CAS number: 2372-21-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date 19 October 1999 , Experimental completion date 25 October 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O,O-tert-butyl isopropyl monoperoxycarbonate
- EC Number:
- 219-143-7
- EC Name:
- O,O-tert-butyl isopropyl monoperoxycarbonate
- Cas Number:
- 2372-21-6
- Molecular formula:
- C8H16O4
- IUPAC Name:
- tert-butoxy propan-2-yl carbonate
- Reference substance name:
- Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
- EC Number:
- 297-629-8
- EC Name:
- Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
- Cas Number:
- 93685-81-5
- Molecular formula:
- not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- isododecane
- Test material form:
- liquid
- Details on test material:
- Trigonox BPIC-C75
Constituent 1
additive 1
- Specific details on test material used for the study:
- Identification: TRIGONOX BPIC·C75
Description: Colourless liquid
Batch: 0419908130562
Purity: 75.8%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Not indicated
Expiry date: 04 October 2000 (allocated at NOTOX, 1 year after receipt of the test substance)
Method
- Target gene:
- The histidine locus in Salmonella typhimurium.
The tryptophan locus in Escherichia coli
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 extracted from the livers of rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Range-finding test:
with and without S9-mix - 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate
Based on results from the range-finding study, the following concentrations were used in the mutagenicity test:
with and without S9-mix - 100, 333, 1000, 3330 and 5000 μg/plate - Vehicle / solvent:
- dimethylsulphoxide
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1 µg/plate for strain TA1535
- Positive control substance:
- sodium azide
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 60 µg/plate for strain TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxid
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 4 µg/plate for strain TA98
- Positive control substance:
- other: daunomycine
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 650 µg/plate for strain TA100
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate for strain WP2uvrA
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate for strain TA1537, 1 µg/plate for strains TA1535, TA98 and TA100 and 5 µg/plate for strain WP2uvrA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid no. 2) and incubated in a shaking incubator (37°C, 150 spm), until the cultures reached an optical density of 0.4 at 700 nm (109 cells/ml). Freshly grown cultures of each strain were used for a test.
DURATION
- Exposure duration: 37ºC for 48 h. (Inadvertently, the plates of the tester strains TA 1535, TA 1537 and T A98 were incubated for 72 hours)
- Selection time (if incubation with a selection agent): 37ºC for 48 h. (Inadvertently, the plates of the tester strains TA 1535, TA 1537 and T A98 were incubated for 72 hours.)
- Environmental conditions: All incubations were carried out in the dark at 37°C. The temperature was monitored during the experiment.
SELECTION AGENT (mutation assays): histidine or tryptophan deficient media
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
To determine the toxicity of TRIGONOX BPIC-C75, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- DOSE RANGE FINDING TEST
TRIGONOX BPIC·C75 was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate in the absence and presence of S9-mix.
This dose range finding test is reported as a part of the mutation test.
Precipitate
The test substance did not precipitate in the top agar. Precipitation of TRIGONOX BPIC-C75 on the plates was not observed at the start or at the end of the incubation period in tester strain TA100 and WP2uvrA.
Toxicity
No reduction of the bacterial background lawn and no decrease in the number of revertants was observed.
Mutagenicity
In the absence of S9-mix, TRIGONOX BPIC-C75 did not induce a dose·related, two·fold, increase in the number of revertant (His+) colonies in tester strain TA 100 and in the number of revertant (Trp+) colonies in tester strain WP2uvrA.
In the presence of S9-mix in tester strain TA 100, TRIGONOX BPIC-C75 induced an up to 5.0·fold, dose related, increase in the number of revertant colonies compared to the solvent control.
In tester strain WP2uvrA, TRIGONOX BPIC-C75 induced an up to 8.7-fold, dose related, increase in the number of revertant colonies compared to the solvent control.
MUTATION ASSAY
Based on the results of the dose range finding study, TRIGONOX BPIC-C75 was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the mutation experiment. The mutation experiment was performed with the strains TA 1535, TA 1537 and TA98.
Precipitate
TRIGONOX BPIC-C75 did not precipitate in the top agar. Precipitation of TRIGONOX BPIC-C75 on the plates was not observed at the start or at the end of the incubation period in all tester strains.
Toxicity of the test substance
The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
Mutagenicity
In the absence of S9-mix, TRIGONOX BPIC-C75 did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the three tester strains (TA 1535, TA1 537 and TA98).
In the presence of S9-mix in tester strain TA 1537, TAIGONOX BPIC-C75 induced an up to 3.0-fold, dose related, increase in the number of revertant colonies compared to the solvent control. In tester strain TA98, TRIGONOX BPIC-C75 induced an up to 1.5-fofd, dose related, increase in the number of revertant colonies compared to the solvent control. In tester strain TA 1535, TRIGONOX BPIC-C75 did not induce a dose-related increase in the number of revertant colonies.
Any other information on results incl. tables
MUTAGENIC RESPONSE OF TRIGONOX BPIC-C75 IN THE SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY AND IN THE ESCHERICHIA COLI REVERSE MUTATION ASSAY
Dose µg/plate |
Mean number of revertant colonies/3 replicate plates (±S.D) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Without S9-mix |
|||||
Positive control |
382 ± 49 |
226 ± 21 |
706 ± 78 |
686 ± 81 |
908 ± 133 |
Solvent control |
16 ± 3 |
11 ± 3 |
35 ± 9 |
76 ± 6 |
12 ± 3 |
3 |
|
|
|
75 ± 16 |
9 ± 4 |
10 |
|
|
|
73 ± 6 |
15 ± 4 |
33 |
|
|
|
57 ± 5 |
10 ± 5 |
100 |
16 ± 8 |
8 ± 3 |
32 ± 4 |
81 ± 10 |
12 ± 2 |
333 |
18 ± 6 |
6 ± 2 |
31 ± 5 |
74 ± 16 |
9 ± 3 |
1000 |
22 ± 1 |
9 ± 2 |
37 ± 7 |
74 ± 17 |
8 ± 1 |
3330 |
19 ± 7 |
11 ± 5 |
40 ± 9 |
83 ± 13 |
9 ± 2 |
5000 |
21 ± 5 |
14 ± 1 |
37 ± 5 |
96 ± 5 |
12 ± 2 |
With S9-mix1 |
|||||
Positive control |
237 ± 18 |
699 ± 34 |
1154 ± 55 |
1141 ± 99 |
71 ± 4 |
Solvent control |
21 ± 2 |
10 ± 2 |
48 ± 2 |
85 ± 5 |
11 ± 2 |
3 |
|
|
|
80 ± 18 |
18 ± 2 |
10 |
|
|
|
78 ± 17 |
13 ± 4 |
33 |
|
|
|
81 ± 18 |
11 ± 1 |
100 |
15 ± 2 |
10 ± 3 |
48 ± 4 |
73 ± 13 |
12 ± 1 |
333 |
17 ± 5 |
11 ± 2 |
57 ± 9 |
101 ± 8 |
13 ± 3 |
1000 |
24 ± 13 |
15 ± 5 |
57 ± 8 |
102 ± 10 |
18 ± 6 |
3330 |
16 ± 6 |
24 ± 2 |
71 ± 8 |
386 ± 30 |
87 ± 9 |
5000 |
17 ± 4 |
30 ± 3 |
64 ± 6 |
429 ± 9 |
96 ± 14 |
Solvent control: 0.1 ml dimethylsulphoxide
1 The S9-mix contained 5% (v/v) S9 fraction
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that TRIGONOX BPIC-C75 is mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
TRIGONOX BPIC-C75 was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA 1535, TA 1537, TA 100 and T A98)
and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvr A.
TRIGONOX BPIC-C75 was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix. TRIGONOX BPIC-C75 did-not precipitate on the plates at this dose level.
The bacterial background lawn was not reduced at all concentrations tested and no decrease in the n umber of revertants was observed.
In the absence of S9-mix, TRIGONOX BPIC-C75 did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA 1537, TA98 and TA 100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA. ·
In the presence of S9-mix in tester strain TA 1537, TRIGONOX BPIC-C75 induced an up to 3.0-fold, dose-related, increase in the number of revertant colonies compared to the solvent control. In tester strain TA98, TAIGONOX BPIC-C75 induced an up to 1.5-fold, dose-related, increase in the number of revertant colonies compared to the solvent control. In tester strain TA 100, TRIGONOX BPIC-C75 induced an up to 5.0-fold, dose-related, increase in the number of revertant colonies compared to the solvent control. In tester strain WP2uvrA, TRIGONOX BPIC-C75 induced an up to 8.7-fold, dose-related, increase in the number of revertant colonies compared to the solvent control. In tester strain TA 1535, TRIGONOX BPIC-C75 did not induce a dose-related increase in the number of revertant colonies.
Based on the results of this study it is concluded that TRIGONOX BPIC-C75 is mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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