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EC number: 247-987-6 | CAS number: 26762-92-5
- 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 vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Remarks:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (standard NTP protocol)
- Qualifier:
- according to guideline
- Guideline:
- other: Standard NTP protocol
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- exposure period 13 weeks
- Principles of method if other than guideline:
- Micronucleus analysis in NTP toxicity studies (13 weeks).
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- data not yet published
- Route of administration:
- dermal
- Vehicle:
- ethanol
- Details on exposure:
- data not yet published
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- once daily, 5 days/week
- Post exposure period:
- 24 h
- Remarks:
- Doses / Concentrations:
0.75, 1.5, 3, 6, 12 mg/kg
Basis: - No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no
- Tissues and cell types examined:
- peripheral blood
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Mice are treated in a 13 week toxicity study as part of the NTP bioassay program
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): sampling collection time is 24 h in the case of single daily exposures
DETAILS OF SLIDE PREPARATION: a blood sample from male and female mice in each dose group is obtained; slides are prepared, fixed and stained
METHOD OF ANALYSIS: 1000 mature erythrocytes ( normochromatic erythrocytes, NCEs ) are scored per animal for the presence of micronuclei (MN); the percent PCE is determined in the blood as a measure of chemical induced toxicity to the bone marrow; all data are analysed seperately for male and female mice; the type of analysis is not given (data not yet published)
- Evaluation criteria:
- Mean MN-NCE/100 NCE
- Statistics:
- A formal statistical analysis of the data is performed that includes a trend test, to determine if there is an overall increase across all doses in the frequency of cells containing micronuclei, and a pairwise comparison of each dose group to the corresponding control, to see if any dose group is statistically different from the control group in the frequency of micronucleated cells.
- Sex:
- male/female
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Additional information on results:
- data not yet published
- Conclusions:
- Interpretation of results (migrated information): negative
Cumene hydroperoxide given dermally for 13 weeks to mice did not induce micronuclei in the peripheral blood of the test animals - Executive summary:
Cumene hydroperoxide was tested in a Micronucleus test (Standard NTP Protocol); the results are available in the Internet; the substance was applied dermally to male and female mice for 13 weeks and than erythrocytes were examined for the presence of micronuclei; under the conditions of this test cumene hydroperoxide was negative in the in vivo mouse micronucleus test.
Reference
The trend test p-value for males was 0.264 and for females 0.777 ( a positive trend test is one in which the p-value is equal to or less than 0.025)
Males
Dose (mg/kg) |
No. of animals scored |
Mean MN-NCE/1000 NCE (+- SEM) |
Pairwise p-value |
0* |
5 |
2.80 (+- 0.70) |
|
0.75 |
5 |
2.70 (+- 0.70) |
0.554 |
1.5 |
5 |
2.90 (+- 0.29) |
0.447 |
3 |
5 |
1.90 (+- 0.37) |
0.906 |
6 |
5 |
2.80 (+- 0.34) |
0.500 |
12 |
5 |
3.10 (+- 0.51) |
0.348 |
*: vehicle control ethanol; SEM: standard error of mean
Females
Dose (mg/kg) |
No. of animals scored |
Mean MN-NCE/1000 NCE (+- SEM) |
Pairwise p-value |
0* |
5 |
1.90 (+- 037) |
|
0.75 |
5 |
1.40 (+- 0.29) |
0.808 |
1.5 |
5 |
2.10 (+- 0.29) |
0.376 |
3 |
5 |
1.50 (+- 0.42) |
0.754 |
6 |
5 |
1.30 (+- 0.25) |
0.856 |
12 |
5 |
1.50 (+- 0.42) |
0.754 |
*: vehicle control ethanol; SEM: standard error of mean
For the micronucleus frequency in any dose group to be considered significantly elevated over the control group, the p value must be equal to or less than 0.025 divided by the number of chemical treatment groups; if the number of treatment groups is 5, then the required pairwise p-value is 0.005; this adjustment in the pairwise value is a correction for multiple comparisons of the same data.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The effects on the test substance in bacterial assays are weakly positive, which was confirmed by tests on structural analogues, o.a. cumenehydroperoxide, which showed positive responses. No effects were found in a chromosome aberration test in Chinese Hamster Lung cells with and without metabolic activation. The structural analogue cumene hydroperoxide was negative in an in vivo micronucleus test. No in vivo tests with the test substance are available, but the test with cumenehydroperoxide is considered to represent a worst case.
It is concluded that the test substance is not mutagenic.
Justification for selection of genetic toxicity endpoint
in vivo study with structural analogue according to standard protocol with sufficient detail to allow evaluation. The structural analogue is considered to be representative of a worst case situation (see attachment chapter 13 on read-across)
Justification for classification or non-classification
The test substance does not need to be classified for mutagenicity, as in a weight of evidence the combined results of in vitro and in vivo tests with either the test substance or the structural analogue cumene hydroperoxide were considered negative, i.e. non-mutagenic.
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