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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 455-560-2 | CAS number: -
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Due to cleaning procedures or performance of functional observations in the room, temporary deviations from the level of humidity (with max 20%) occurred. Based on lab historical data these deviations are considered not to affect the study integrity.
- GLP compliance:
- yes
- Type of assay:
- other: mammalian germ cell cytogenic assay: micronucleus
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Specific details on test material used for the study:
- Clear colourless liquid, purity 96.5%.
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Remarks:
- NMRI BR (SPF)
- Details on species / strain selection:
- The mice selected (NMRI BR (SPF) are recommended by international guidelines.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Females were nulliparous and non-pregnant. The animals were provided by Charles River, Sulzfeld, Germany.
Young adult animals were selected (6-8 weeks old). The body weights of the mice at the start of the treatment were within 20% of the sex mean.
Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21 +/- 3 oC and a relative humidity of 30-70%. The room was illuminated with 12 hours artificial fluorescent light and 12 hours dark per day.
Accomodation:
Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing Woody Clean bedding (Woody-Clean type 3/4: Tecnilab-BMIBV, Someren, The Netherlands). Paper bedding was provided as nest material (B.M.I. Helmond, The Netherlands). Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet:
Free access to standard pelletized laboratory animal diet (code VRF 1, Altromin, Lage, Germany).
Water:
Free access to tap water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- The mice received an oral intubation of a maximum tolerated (high), an intermediate and a low dose of Pentamethyl-trioxepane. The route of administration was selected taking into account the possible route of human exposure during manufacture, handling and use.
Feed was withheld 3-4 h prior to dosing.
The dosing volume was 10 ml/kg body weight. The route and frequency of administration and the volume administered of the negative and positive control was the same as those of the test article.
The systemic toxic signs were recorded at least once a day. The time of death was recorded as precisely as possible. The animals were weighed just prior to dosing. - Duration of treatment / exposure:
- single treatment via oral intubation, exposure period/sampling time 24 hrs, with an additional one at 48 hrs for high dose (1000 mg/kg bw male, 750 mg/kg bw female)
- Frequency of treatment:
- once
- Post exposure period:
- 24hrs and 48 hrs for high dose groups (1000 mg/kg bw male, 750 mg/kg bw female)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- male
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- male
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Remarks:
- male
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- Remarks:
- female
- Dose / conc.:
- 375 mg/kg bw/day (actual dose received)
- Remarks:
- female
- Dose / conc.:
- 190 mg/kg bw/day (actual dose received)
- Remarks:
- female
- No. of animals per sex per dose:
- five
- Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide (CP; CAS 50-18-0; Endoxan, Asta-Werke, Germany) dissolved in physiological saline (B. Braun, Melsungen, Germany) dosed as a single oral intubation of 50 mg/kg body weight.
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- Bone marrow samples: femurs were removed from the animals and flushed with 2 ml fetal calf serum. The cell suspension is collected and centrifuged at 1000 rpm for 5 min. supernatant was removed with a Pasteur pipette. One drop of serum was left. One drop of cell suspension is placed on a slide. 2 slides were prepared per animal. Slides were stained using the “Wright-stain procedure” in an “Ames” HEMA-tek slide stainer. Slides were scored at 1000x magnification.
- Evaluation criteria:
- The polychromatic/normochromatic ratio was determined by counting and differentiating the 1st 1000 erythorcytes at the same time. 2000 micronucleated polychromatic erythrocytes were examined.
- Statistics:
- The polychromatic/normochromatic ratio was determined. Averages and standard deviations were calculated. A wilcoxon rank sum test; two sided test at p < 0.05 was used to test if there was a significant increase in micronucleated polychromatic erythrocytes.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Cyclophosphamide induced a significant increase in the number of micronucleated polychromatic erythrocytes and a decrease in the polychromatic to normochromatic erythrocytes ratio (= toxic effects on erythropoiesis). The animals treated with pentamethyl-trioxepane and the negative control showed no increase in the number of micronucleated polychromatic erythrocytes and no decrease in the polychromatic to normochromatic erythrocytes ratio.
During the first hours the highest dose groups showed ataxia and increased activity. Within 18 hours the animals recovered.
Applicant's summary and conclusion
- Conclusions:
- pentamethyl-trioxepane is not mutagenic in the micronucleus test under the experimental conditions described in this report.
- Executive summary:
pentamethyl-trioxepane is not mutagenic in the micronucleus test under the experimental conditions described in this report.
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.