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EC number: 946-061-5 | 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: Micronucleus assay
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 611-563-2
- Cas Number:
- 57635-48-0
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- sesame oil, at volume of 10mg/kg bw
- Duration of treatment / exposure:
- 2
- Frequency of treatment:
- one application per day
- Post exposure period:
- The animals were sacrificed 24hours after second application.
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 5 males and 5 females as controls
5 males and 5 females for treatment with test material
5 males and 5 females for positive control (Endoxan, cyclophosphamide) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 5 males and 5 females were treated with Endoxan once orally by gavage at a dose of 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- 2000 polychromatic erythrocytes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- decreased motor activity and squatting posture
- Vehicle controls validity:
- valid
- Remarks:
- sesame oil, 10 mg/mL
- Positive controls validity:
- valid
- Remarks:
- Endoxan, cyclophosphamide
Any other information on results incl. tables
Mice were treated twice with 2000 mg Emulsogen COL 020 per kg body weight to study the induction of micronuclei in bone marrow cells. All animals survived after treatment. The following signs of toxicity were observed: motor activity decreased and squatting posture. 24 hours after application all animals were free of clinical signs of toxicity. The dissection of the animals revealed no test substance related macroscopic findings. The bone marrow smears were examined for the occurrence of micronuclei in red blood cells. The results are summarized on page 19. Individual data of all animals in all treatment groups are presented on page 20. The incidence of micronucleated polychromatic erythrocytes in the dose group of Emulsogen COL 020 was within the normal range of the negative control groups. No statistically significant increase of micronucleated polychromatic erythrocytes was observed. The ratio of polychromatic erythrocytes to total erythrocytes remained essentially unaffected by the test compound and was not less than 20% of the control values in the pooled data. Cyclophosphamide (Endoxan®) induced a marked and statistically significant increase in the number of polychromatic erythrocytes with micronuclei, thus indicating the sensitivity of the test system.
Applicant's summary and conclusion
- Conclusions:
- No effect in in-vivo micronucleus assay in mouse
- Executive summary:
The genotoxicity of the registration substance was investigated according to the OECD Guideline 474. Mice were treated at dose of 2000 mg/kg bw once per day for two days. 24hours after the seconed application the animals were sacrificed and the bone marros cells were collected. The incidence of mucronucleated polychromatic erythrocytes was comparable for treated and control mice. The ratio of polychromatic erythrocytes to total erhythrocytes remained unaffected. No clastogenic effect was found.
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