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EC number: 240-282-4 | CAS number: 16111-62-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Two Ames tests (OECD 471) and a micronucleus test in human lymphocytes (OECD 487) for bis(2-ethylhexyl) peroxydicarbonate; and a mouse lymphoma test (OECD 476) for two potentially relevant degradation products. As bis(2-ethylhexyl)peroxydicarbonate hydrolyses instantly in aqueous solutions and degradation products are formed the peroxide itself will not be present systemically. Thus, the risk assessment for bis(2-ethylhexyl)peroxydicarbonate is based on data available for the breakdown products 2-ethylhexanol (84.4–96.9 %) and 2-ethylhexanoic acid (max. 3.2 %).
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487 (adopted 22. Jul 2010)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes: human periheral blood obtained by a donor
- Details on mammalian cell type (if applicable):
- Human peripheral blood lymphocytes were obtained from an adequate donor (healthy, non-smoking, no known recent exposures to genotoxic chemicals or radiation). Blood samples were drawn by venous puncture and collected in heparinized tubes. Blood cultures were set up within 24 hours after sample collection.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from the liver of male rats
- Test concentrations with justification for top dose:
- Pre-exp (Exp. I): 3472, 2951, 2508, 2258, 2032, 1524, 990, 495 µg/mL
Exp. II: 3465, 2945, 2503, 2253, 2028, 1521, 989, 494 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetra hydrofuran (THF) for the test material and 0.9% NaCl for the positive controls.
- Justification for choice of solvent/vehicle: based on the pre-experiment (exp. I) the test material was sufficiently soluble in THF. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetra hydrofurane (THF)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- With S9-Exp. I & II
-Exposure duration: 4 ± 1 h; the medium was removed, fresh medium and cytoB were added. The cells were harvested 1.5-2 cell cycles later.
Without S9-Exp. I
-Exposure duration: 4 ± 1 h; the medium was removed, fresh medium and cytoB were added. The cells were harvested 1.5-2 cell cycles later.
Without S9, extended exposure-Exp. II
-Exposure duration: 20 ± 2 h (1.5 - 2 cell cycles) in the presence of cytoB. The cells were harvested at the end of the exposure period.
SPINDLE INHIBITOR (cytogenetic assays): cytoB
STAIN (for cytogenetic assays): 10% solution of Giemsa
NUMBER OF REPLICATIONS: two
NUMBER OF CELLS EVALUATED: at least 500 cells per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index (cytokinesis-block proliferation index) - Evaluation criteria:
- The test item is considered to have no genotoxic effects if:
-the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory’s historical control data of the solvent control
-no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
The test item is considered to have genotoxic effects if:
-the number of micronucleated cells in all evaluated dose groups is above the range of the historical laboratory control data
-either a concentration-related increase of micronucleated cells or a statistically significant increase in the number of cells containing micronuclei is observed. - Statistics:
- Statistical significance when p<0.01
- Species / strain:
- lymphocytes: human, peripheral blood
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Solubility of the test substance was determined in a seperate test.The test item was sufficiently soluble in tetra hydrofurane (THF).
Exp.I: no cytotoxicity or precipitation in any of the concentrations tested. The highest concentration showed haemolysis. No micronuclei were detected at all concentrations tested.
Exp.II: no cytotoxicity or precipitation in any of the concentrations tested. Sigificant increases in the number of binucleated cells with miconuclei when compared to the THF, were not considered a genotoxic effect, since the increase was lower than that observed in the solvent control NaCl 0.9%.
The study is considered acceptable, since micronucleus induction of the controls was in the range of historical data.
For detailed results see "any other informaion on results incl. tables". - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
On the basis of this result, the test item does not induce chromosomal aberrations in human lymphocytes. - Executive summary:
In a mammalian cell cytogenicity test (micronucleus test) human peripheral blood lymphocytes (obtained by a donor) were exposed to PEROXAN EPC S (analytical purity: 98.1%) in tetradyrofuran (THF) in the presence and absence of mammalian metabolic activation (liver S9 mix, male rats, treated with Aroclor 1254). Prior to exposure the cells were properly cultured in the presence of phytohaemagglutinin.
Three experiments were run. The first experiment was deemed invalid and therefore, it is not reported here. The rest two were as follows:
Experiment I
With and without S9 mix / 4 hrs exposure: 3472, 2951, 2508, 2258, 2032, 1524, 990, 495 µg/mL
Micronuclei were scored at 3472, 2951, 2508 µg/mL
Experiment II
With and without S9 mix / 20 ± 2 hrs exposure: 3465, 2945, 2503, 2253, 2028, 1521, 989, 494 µg/mL
Micronuclei were scored at 3465, 2945, 2503 µg/mL
Cytotoxicity was not seen at any concentration level. There was no evidence of a biologically relevant increase in the micronucleated cells at all concentrations tested. The positive controls did induce the appropriate response and the negative controls were within the normal range according to historical data.
This study is classified as acceptable.This study satisfies the requirement for Test Guideline OECD 487 for in vitro cytogenicity (mammalian cell micronucleus test) data.
Reference
Table 8.1-a ResultsofCytotoxicityTestExperiment l in theabsenceofS9
Treatment |
Precipitation |
Haemolysis |
CBPI |
%Cytostasis |
Solvent control THF |
No |
No |
1.86 |
|
Solvent control 0.9 % NaCI |
No |
No |
1.97 |
|
Positive control MMC 0.3 µg/mL |
No |
No |
1.86 |
4.0% |
Test Item |
|
|
|
|
3472 µg/mL |
No |
Yes |
1.56 |
16.1% |
2951 µg/mL |
No |
No |
1.61 |
13.4% |
2508 µg/mL |
No |
No |
1.82 |
2.1% |
2258 µg/mL |
No |
No |
1.73 |
6.9% |
2032 µg/mL |
No |
No |
1,74 |
6.5% |
1524 µg/mL |
No |
No |
1.65 |
11.3% |
990 µg/mL |
No |
No |
1.86 |
0.3% |
495 µg/mL |
No |
No |
1.78 |
4.2% |
Table8.1-b ResultsofCytotoxicityTestExperimentlinthepresenceofS9
Treatment |
Precipitation |
Haemolysis |
CBP |
% Cytostasis |
SolventcontrolTHF |
no |
no |
1.79 |
|
Solventcontrol0.9%NaCI |
no |
no |
1.79 |
|
PositivecontrolCPA 151- µg/mL |
no |
no |
1.47 |
17.7% |
Test Item |
|
|
|
|
3472µg/mL |
no |
yes |
1.60 |
10.2% |
2951µg/mL |
no |
no |
1.69 |
5.3% |
2508µg/mL |
no |
no |
1.61 |
10.1% |
2258µg/mL |
no |
no |
1.64 |
8.2% |
2032µg/mL |
no |
no |
1.69 |
5.3% |
1524µg/mL |
no |
no |
1.77 |
0.9% |
990µg/mL |
no |
no |
1.83 |
-2.7% |
495µg/mL |
no |
no |
1.86 |
-3.9% |
Table 8.1-c Genotoxicity Results Experiment I
Treatment |
Average CBPI |
Cytostasis (%) |
Total No. of BNC examined |
Total No. of MBNC |
% MBNC |
|
Experiment I: exposure period 4 hrs without S9 |
||||||
SolventcontrolTHF |
1.86 |
-- |
2035 |
11 |
0.54% |
|
SolventcontrolNaCl0.9% |
1.94 |
-- |
2276 |
8 |
0.35% |
|
PositivecontrolMMC0.3µg/mL |
1.86 |
4.0% |
2100 |
79 |
**3.76% |
|
Test item3472µg/mL |
1.56 |
16.1% |
2067 |
9 |
0.44% |
|
Test item2951µg/mL |
1.61 |
13.4% |
2111 |
3 |
0.14% |
|
Test item2508µg/mL |
1.82 |
2.1% |
2093 |
1 |
0.05% |
|
Experiment I: exposure period 4 hrs with S9 |
||||||
SolventcontrolTHF |
1.79 |
-- |
2025 |
10 |
0.49% |
|
SolventcontrolNaCI0.9% |
1.79 |
-- |
2055 |
9 |
0.44% |
|
PositivecontrolCPA15µg/mL |
1.47 |
17.7% |
2139 |
70 |
**3.27% |
|
Testitem3472µg/mL |
1.60 |
10.2% |
2060 |
5 |
0.24% |
|
Testitem2951µg/mL |
1.69 |
5.3% |
2083 |
7 |
0.34% |
|
Testitem2508µg/mL |
1.61 |
10.1% |
2074 |
4 |
0.19% |
|
Table8.2-a ResultsofCytotoxicity TestExperiment IIin theabsenceofS9
Treatment |
Precipitation |
Haemolysis |
CBPI |
%Cytostasis² |
Solvent control THF |
No |
No |
1.84 |
|
Solvent control 0.9 % NaCI |
No |
No |
1.93 |
|
Positive control MMC 0.3 µg/mL |
No |
No |
1.81 |
6.4% |
Test Item |
|
|
|
|
3465 µg/mL |
No |
No |
1.71 |
7.2% |
2945 µg/mL |
No |
No |
1.71 |
7.5% |
2503 µg/mL |
No |
No |
1.76 |
4.7% |
2253 µg/mL |
No |
No |
1.68 |
9.0% |
2028 µg/mL |
No |
No |
1,70 |
7.9% |
1521 µg/mL |
No |
No |
1.67 |
9.3% |
989 µg/mL |
No |
No |
1.76 |
4.6% |
494 µg/mL |
No |
No |
1.75 |
4.9% |
Table 8.2-b Results of Cytotoxicity Test Experiment II in the presence of S9
Treatment |
Precipitation |
Haemolysis |
CBPI |
%Cytostasis² |
Solvent control |
No |
No |
1.80 |
|
Solvent control 0.9 % NaCI |
No |
No |
1.73 |
|
Positive control CPA 15 µg/mL |
No |
No |
1.53 |
11.5% |
Test Item |
|
|
|
|
3465 µg/mL |
No |
No |
1.77 |
1.6% |
2945 µg/mL |
No |
No |
1.86 |
-3.4% |
2503 µg/mL |
No |
No |
1.81 |
-0.1% |
2253 µg/mL |
No |
No |
1.85 |
-2.5% |
2028 µg/mL |
No |
No |
1,76 |
2.3% |
1521 µg/mL |
No |
No |
1.81 |
-0.1% |
989 µg/mL |
No |
No |
1.79 |
0.5% |
494 µg/mL |
No |
No |
1.82 |
-1.0% |
Table 8.2-c Results Experiment II
Concentrations (µg/mL) |
Average CBPI |
Cytostasis (%) |
Total No. of BNC examined |
Total No. of MBNC |
% MBNC |
|
Experiment II: exposure period 22 ± 2hrs without S9 |
||||||
SolventcontrolTHF |
1.84 |
-- |
2046 |
5 |
0.24% |
|
SolventcontrolNaCl0.9% |
1.93 |
-- |
2041 |
15 |
*0.73% |
|
PositivecontrolMMC0.3µg/mL |
1.81 |
6.4% |
2107 |
59 |
**2.80% |
|
Test item3465µg/mL |
1.71 |
7.2% |
2059 |
14 |
**0.68% |
|
Test item2945µg/mL |
1.71 |
7.5% |
1849 |
13 |
*0.70% |
|
Test item2503µg/mL |
1.76 |
4.7% |
2040 |
13 |
*0.64% |
|
Experiment I: exposure period 4 hrs with S9 |
||||||
SolventcontrolTHF |
1.80 |
-- |
2040 |
5 |
0.25% |
|
SolventcontrolNaCI0.9% |
1.73 |
-- |
2032 |
7 |
0.34% |
|
PositivecontrolCPA15µg/mL |
1.53 |
11.5% |
1825 |
33 |
**1.81% |
|
Test item3465µg/mL |
1.77 |
1.6% |
2110 |
6 |
0.28% |
|
Test item2945µg/mL |
1.86 |
-3.4% |
2044 |
7 |
0.34% |
|
Test item2503µg/mL |
1.81 |
0.1% |
2026 |
7 |
0.35% |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Additional information from genetic toxicity in vitro:
No effects have been reported in a suitable test battery including in-vitro genotoxicity tests in bacteria and mammalian cells, and a cytogenicity test in mammalian cells.
Justification for selection of genetic toxicity endpoint
(key study) GLP guideline study
Justification for classification or non-classification
No effects have been reported in a suitable test battery including in-vitro genotoxicity tests in bacteria and mammalian cells, and a cytogenicity test in mammalian cells.
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