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EC number: 700-954-4 | CAS number: 1338-23-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Basic information are available. No guideline followed.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- NTP Technical report on toxicity studies of methyl ethyl ketone peroxide (CAS No. 1338-23-4) in Dimethyl phthalate (CAS No. 131-11-3) (45:55)
- Author:
- Zeiger, E.
- Year:
- 1 993
- Bibliographic source:
- NIH Publication 93-3341
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol
- EC Number:
- 700-954-4
- Cas Number:
- 1338-23-4
- Molecular formula:
- Mixture of C4H10O4 and C8H18O6
- IUPAC Name:
- 2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Dimethyl phthalate
- Details on exposure:
- NA
- Duration of treatment / exposure:
- 13-week
- Frequency of treatment:
- once
- Post exposure period:
- NA
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.357 other: mg/animal
- Dose / conc.:
- 1.19 other: mg/animal
- Dose / conc.:
- 3.57 other: mg/animal
- Dose / conc.:
- 11.9 other: mg/animal
- Dose / conc.:
- 35.7 other: mg/animal
- No. of animals per sex per dose:
- 10 female and 10 male animals per dose
- Control animals:
- yes
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- erythrocytes in peripheral blood samples
- Details of tissue and slide preparation:
- The methanol-fixed slides were stained with a chromatin-specific fluorescent dye mixture of Hoechst 33258/pryronin Y and were coded. Slides were scanned using a semi-automated image analysis system to determine the frequency of micronuclei in 10,000 normochromatic erythrocytes (NCEs) and 2000 polychromatic erythrocytes (PCEs) for each of 10 males and 10 females per dose group.
- Evaluation criteria:
- The criteria of Schmid (1976) were used in defining micronuclei, with the additional requirement that micronuclei exhibit the characteristic fluorescent emissions of DNA. The percentage of PCEs among the total erythrocyte population was also determined.
- Statistics:
- Log transformation of the normochromatic erythrocyte (NCE) data, and testing for normality by the Shapiro-Wilk test, and for heterogeneity of variance by Cochran`s test, were performed before statistical analyses. The frequency of micronucleated cells among NCEs was analyzed by an analysis of variance using the SAS GLM procedure. The NCE dat for each dose group were compared with data from the concurrent DMP control using Student`s t-test. The frequency of micronucleated cells among polychromatic erythrocytes (PCEs) was analyzed by the Cochran-Armitage trend test, and individual dose groups were compared to the concurrent DMP control by Kastenbaum- Bowman`s (1970) binomial test. The percentage PCE among total erythrocytes was analyzed by an analysis of variance on ranks (classed by sex) and invidual dose groups were compared with concurrent DMP control using a t-test on ranks.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not examined
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Appropriateness of dose levels and route: Mice of the 2 highest dose groups were not evaluated for mutagenicity due to earlier termination due to severe skin lesions.
Applicant's summary and conclusion
- Conclusions:
- No increase was observed in frequency of micronucleated erythrocytes in peripheral blood samples obtained from male and female mice at the end of the 13-week dermal toxicity study.
- Executive summary:
The potential of methyl-ethylketone peroxide in DMP to induce micronuclei in the peripheral blood of mice was investiged after a 13 week dermal exposure of 0.357 to 3.57 mg methyl-ethylketone peroxide/animal. At this concentration severe skin damage was obsered. Thus it can be assumed that the test item became systemically available. No increase was observed in frequency of micronucleated erythrocytes in peripheral blood samples obtained from male and female mice at the end of the 13-week dermal study.
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