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EC number: 203-326-3 | CAS number: 105-74-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Apparently well conducted GLP study; only one positive control with S9; no viable cell concentration provided; marker verification was not reported (if conducted)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dilauroyl peroxide
- EC Number:
- 203-326-3
- EC Name:
- Dilauroyl peroxide
- Cas Number:
- 105-74-8
- Molecular formula:
- C24H46O4
- IUPAC Name:
- dodecanoyl dodecaneperoxoate
- Details on test material:
- The test substance, DILAUROYL PEROXIDE, used in the study was supplied by Elf Atochem Deutschland.
Documentation supplied by the Sponsor identified the test substance as follows:
denomination:
- protocol:DILAUROYL PEROXIDE
batch number:
- protocol and labelling: 110-9502-34
description: whitish powder
quantity and container: two plastic bags each containing 0.1 kg
date of receipt: 18.5.95
storage conditions: at room temperature, protected from light
purity: 99.7%.
Constituent 1
Method
- Target gene:
- Each strain derived from Salmonella typhimurium LT 2 contains one mutation in the
histidine operon, resulting in a requirement for histidine.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: See "Any other information on materials and methods incl. tables"
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: See "Any other information on materials and methods incl. tables"
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fraction of rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- The top dose-level was selected according to the criteria specified in the international
regulations. Since the test substance was non-toxic, poorly soluble, the top dose-level was
the lowest precipitating dose: approximately 1500 ug/plate.
The selected dose-levels were for the first experiment:
· 15, 50, 150, 500 and 1500 ug/plate;
as precipitation again interfered with the scoring at 1500 ug/plate, the dose-treatments were
decreased for the second experiment as follows:
5, 15, 50, 150 and 500 ug/plate.
The dose-levels selected for the third experiment with the TA 1537 with S9 mix were: 15,
50, 150, 500 and 1500 ug/plate.
The dose-levels of the positive controls were as follows:
without S9 mix:
1 ug/plate of sodium azide (NaN3): TAl535 and TA 100 strains,
50 ug/plate of 9-Aminoacridine (9AA): TA 1537 strain,
0.5 ug/plate of 2-Nitrofluorene (2NF): TA 98 strain,
0.5 ug/plate of Mitomycin C (MMC): TAl02 strain.
with S9 mix:
2 ug/plate of2-Anthramine (2AM): TA 1535, TA 1537, TA 98 and TA 100 strains,
10 ug/plate of 2-Anthramine (2AM): TA 102 strain. - Vehicle / solvent:
- tetrahydrofuran
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: TA 1535, TA 100
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: TA 1537
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: TA 98
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: TA 102
- Positive controls:
- yes
- Remarks:
- +S9
- Positive control substance:
- other: 2-anthramine
- Details on test system and experimental conditions:
- The experiments were performed according to:
Direct plate incorporation method (preliminary toxicity tests, both experiments without
S9 mix, first and third experiments with S9 mix): test substance solution (0.05 to 0.1 ml),
S9 mix (0.5 ml) when required and bacterial suspension (0.1 ml) were mixed with 2 ml
of overlay agar (containing traces of the relevant aminoacid and biotin and maintained at
45°C). After rapid homogenization, the mixture was overlaid onto a Petri plate containing
minimum medium.
Preincubation method (second experiment with S9 mix): test substance solution (0.05 to
0.1 ml), S9 mix (0.5 ml) and bacterial suspension (0.1 ml) were incubated for 60 minutes
at 37°C before adding the overlay agar and pouring onto the surface of a minimum agar
plate.
After 48 to 72 hours of incubation at 37°C, revertants were scored with an automatic
counter (Artek counter, model 880, O.S.I., 75015 Paris, France). - Evaluation criteria:
- Treatment of results
In each experiment, for each strain and for each experimental point, the number of revertants per plate was scored. ,
Acceptance criteria
This study was considered valid since the following criteria were fully met:
· the number of revertants in the vehicle controls was within the range of our historical data
· the number of revertants in the positive controls was higher than that of the vehicle
controls and was within the range of our historical data.
Evaluation criteria
A reproducible two-fold increase in the number of revertants compared with the vehicle
controls, in any strain at any dose-level and/or evidence of a dose-relationship was
considered as a positive result. Reference to historical data, or other considerations of
biological relevance may also be taken into account in the evaluation of the data obtained. - Statistics:
- NA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants of the vehicle and positive controls was as specified in the
acceptance criteria and within the range of the historical data.
The top dose-level was selected according to the criteria specified in the international
regulations. Since the test substance was non-toxic, poorly soluble, the top dose-level was
the lowest precipitating dose: approximately 1500 ug/plate.
The selected dose-levels were for the first experiment:
. 15, 50, 150, 500 and 1500 ug/plate;
as precipitation again interfered with the scoring at 1500 ug/plate, the dose-treatments were
decreased for the second experiment as follows:
. 5, 15, 50, 150 and 500 ug/plate.
The dose-levels selected for the third experiment with the TA 1537 with S9 mix were: 15,
50, 150, 500 and 1500 ug/plate.
The test substance did not induce any significant increase in the number of revertants, with
and without S9 mix, in any of the five strains. Indeed, the slight 2.4 fold increase observed
at 500 and 1500 ug/plate in the first experiment with S9 mix in the TA 1537 strain was
attributed to the low value of revertants in the concurrent vehicle controls and was not
taken into account since it was not reproduced in the second and third experiments and
since the value obtained remained in our historical data.
Any other information on results incl. tables
See attachment
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test substance DILAUROYL
PEROXIDE did not show mutagenic activity in this bacterial reverse mutation test on
Salmonella typhimurium. - Executive summary:
The objective of this study was to evaluate the potential of the test substance DILAUROYL PEROXIDE to induce reverse mutation in Salmonella typhimurium.
Preliminary toxicity tests were performed to define the dose-levels of DILAUROYL PEROXIDE to be used for the mutagenicity study. DILAUROYL PEROXIDE was then tested in two independent experiments, with or without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254. A third experiment with S9 mix was also performed in the TA 1537 strain. The experiments were performed according to the direct plate incorporation method except the second with S9 mix, which was performed according to the preincubation method (60 minutes, 37 deg C). Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA102 were used. Each strain was exposed to five dose-levels of the test substance (three plates/dose-level). After 48 to 72 hours of incubation at 37 deg C, the revertant colonies were scored. The test substance DILAUROYL PEROXIDE was dissolved in tetrahydrofuran.
The top dose-level was selected according to the criteria specified in the international regulations. Since the test substance was non-toxic, poorly soluble, the top dose-level was the lowest precipitating dose: approximately 1500 ug/plate. The selected dose-levels were for the first experiment: 15, 50, 150,500 and 1500 ug/plate; as precipitation again interfered with the scoring at 1500 ug/plate, the dose-treatments were decreased for the second experiment as follows: 5, 15, 50, 150 and 500 ug/plate. The dose-levels selected for the third experiment with the TA 1537 with S9 mix were: 15, 50, 150, 500 and 1500 ug/plate.
The test substance did not induce any significant increase in the number of revertants, with and without S9 mix, in any of the five strains. Indeed, the slight 2.4 fold increase observed at 500 and 1500 ug/plate in the first experiment with S9 mix in the TA 1537 strain was attributed to the low value of revertants in the vehicle controls and was not taken into account since it was not reproduced in the second and third experiments.
Under the experimental conditions, the test substance DILAUROYL PEROXIDE did not show mutagenic activity in this bacterial reverse mutation test on Salmonella typhimurium.
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