Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-279-3 | CAS number: 80-43-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- & OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Principles of method if other than guideline:
- Guidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(α,α-dimethylbenzyl) peroxide
- EC Number:
- 201-279-3
- EC Name:
- Bis(α,α-dimethylbenzyl) peroxide
- Cas Number:
- 80-43-3
- Molecular formula:
- C18H22O2
- IUPAC Name:
- 1,1'-(dioxydipropane-2,2-diyl)dibenzene
- Details on test material:
- - Name of test material (as cited in study report): dicumyl peroxide
- Molecular formula (if other than submission substance): C18H22O2
- Substance type: white solid (flake form)
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: 8X04
- Stability under test conditions: stable at normal temperature
Constituent 1
Method
Species / strainopen allclose all
- 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:
- S9 mix from rat liver, induced with phenobarbital and 5,6-benzoflavon
- Test concentrations with justification for top dose:
- cytotoxicity: 50, 150, 500, 1500, 5000 µg/plate
mutagenicity: 313, 625, 1250, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98, WP2 uvrA), Sodium azide (TA1535) and 9-Aminoacridine (TA1537) +S9 mix; 2-Aminoanthracene (five strains)
- Details on test system and experimental conditions:
- Pre-incubation method
- Evaluation criteria:
- The results were judged to be positive when the mean number of revertant colonies for each dose of the test article was increased twice or more than that in the negative control and when dose dependency or reproducibility was observed in the increase of revertant colonies, in at least one strain out of the five strains used with or without S9 mix.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertant colonies was not increased twice or more than that in the negative control in any strain used with or without S9 mix in the two mutagenicity tests. In all tests, microbial contamination was not detected in the dosing formulation of the highest concentration or S9 mix. Furthermore, positive results were confirmed in the positive control groups, and the mean numbers of revertant colonies in the positive and negative controls were within the fluctuation range (mean ± 3 S.D.) of the historical control values in all strains. Thus, the validity of this test system was confirmed.
Any other information on results incl. tables
Table 1: Mutagenicity of dicumyl peroxide in bacteria (I)
|
|
|
|
No colonies/plate |
|
|
+/- S9mix |
DCP (µg/plate) |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
- |
0 |
163 ± 2.1 |
12 ± 1.5 |
19 ± 4.7 |
27 ± 4.0 |
12 ± 4.0 |
- |
313 |
158 ± 15.6 |
9 ± 1.7 |
25 ± 5.1 |
21 ± 4.2 |
10 ± 3.2 |
- |
625 |
131 ± 9.2 |
20 ± 2.0 |
20 ± 2.0 |
15 ± 1.0 |
9 ± 4.9 |
- |
1250 |
157 ± 20.0 |
18 ± 2.0 |
18 ± 2.0 |
18+-4.5 |
7+-1.5 |
- |
2500 |
156 ± 8.0 |
21 ± 5.5 |
21 ± 5.5 |
17 ± 3.8 |
5 ± 0.6 |
- |
5000 |
152 ± 18.0 |
23 ± 3.6 |
23 ± 3.6 |
24 ± 0.6 |
6 ± 2.3 |
+ |
0 |
154 ± 8.3 |
24 ± 8.4 |
24 ± 8.4 |
33 ± 4.4 |
16 ± 2.5 |
+ |
313 |
164 ± 2.9 |
27 ± 4.0 |
27 ± 4.0 |
35 ± 8.7 |
15 ± 1.0 |
+ |
625 |
173 ± 7.0 |
29 ± 5.2 |
29 ± 5.2 |
20 ± 1.0 |
13 ± 0.6 |
+ |
1250 |
141 ± 5.8 |
23 ± 7.4 |
23 ± 7.4 |
21 ± 3.0 |
11 ± 3.1 |
+ |
2500 |
135 ± 21.6 |
24 ± 8.3 |
24 ± 8.3 |
28 ± 2.9 |
13 ± 1.5 |
+ |
5000 |
143 ± 14.5 |
23 ± 4.6 |
23 ± 4.6 |
22 ± 5.9 |
10 ± 4.7 |
|
Chemical |
AF-2 |
SA |
AF-2 |
AF-2 |
9AA |
|
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
- |
No colonies/plate |
742 ± 20.0 |
702 ± 4.5 |
242 ± 18.9 |
648 ± 18.0 |
616 ± 41.5 |
|
Chemical |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
+ |
No colonies/plate |
1204 ± 51.4 |
413 ± 15.6 |
878 ± 88.1 |
518 ± 38.6 |
314 ± 34.8 |
Table 2: Mutagenicity of dicumyl peroxide in bacteria (II)
|
|
|
|
No colonies/plate |
|
|
+/- S9mix |
DCP (µg/plate) |
TA100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
- |
0 |
127 ± 20.0 |
14 ± 0.6 |
22 ± 1.2 |
23 ± 3.5 |
7 ± 3.2 |
- |
313 |
129 ± 12.3 |
14 ± 2.6 |
22 ± 4.6 |
19 ± 2.6 |
5 ± 2.0 |
- |
625 |
139 ± 9.0 |
10 ± 2.5 |
25 ± 8.6 |
21 ± 2.6 |
6 ± 0.0 |
- |
1250 |
124 ± 5.5 |
11 ± 3.0 |
17 ± 4.6 |
21 ± 2.6 |
5 ± 5.0 |
- |
2500 |
109 ± 7.8 |
11 ± 2.0 |
23 ± 1.5 |
18 ± 2.6 |
6 ± 0.6 |
- |
5000 |
123 ± 23.0 |
9 ± 4.5 |
18 ± 1.5 |
19 ± 1.2 |
4 ± 0.6 |
+ |
0 |
127 ± 20.1 |
11 ± 2.1 |
31 ± 1.2 |
18 ± 1.7 |
15 ± 5.2 |
+ |
313 |
161 ± 15.6 |
13 ± 1.2 |
28 ± 3.8 |
26 ± 5.5 |
8 ± 2.0 |
+ |
625 |
137 ± 19.6 |
12 ± 3.6 |
35 ± 3.5 |
26 ± 6.4 |
16 ± 4.9 |
+ |
1250 |
139 ± 13.2 |
9 ± 0.6 |
28 ± 3.1 |
22 ± 2.6 |
10 ± 4.6 |
+ |
2500 |
131 ± 8.7 |
8 ± 5.1 |
33 ± 1.0 |
27 ± 1.5 |
13 ± 4.6 |
+ |
5000 |
125 ± 9.5 |
9 ± 5.7 |
27 ± 5.7 |
21 ± 4.4 |
6 ± 2.1 |
|
Chemical |
AF-2 |
SA |
AF-2 |
AF-2 |
9AA |
|
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
- |
No colonies/plate |
649 ± 28.5 |
714 ± 56.2 |
216 ± 8.7 |
640 ± 20.0 |
611 ± 99.0 |
|
Chemical |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
+ |
No colonies/plate |
970 ± 54.2 |
347 ± 12.6 |
1020 ± 72.7 |
440 ± 63.5 |
237 ± 30.1 |
At all concentrations of dicumyl peroxide precipitate was observed on the surface of the agar plates.
Applicant's summary and conclusion
- Conclusions:
- Dicumyl peroxide did not induce gene mutation in bacteria when tested up to 5000 µg/plate, both with and without metabolic activation.
- Executive summary:
A bacterial reverse mutation test (according to OECD 471) of bis(1-methyl-1-phenylethyl) peroxide in bacteria was carried out. This substance was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system when tested up to the limit concentration of 5000 µg/plate.
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.