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EC number: 203-444-5 | CAS number: 106-93-4
- 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 germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- publication
- Title:
- Ethylene dibromide: negative results with the mouse dominant lethal assay and the electrophoretic specific-locus test.
- Author:
- Barnett, L.B., Lovell, D.P., Felton, C.F., Gibson, B.J., Cobb, R.R., Sharpe, D.S., Shelby, M.D. & Lewis, S.E.
- Year:
- 1 992
- Bibliographic source:
- Mutation Research, Vol. 282 (1992), pp. 127-133, © 1992 Elsevir Science Publishers B.V.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- EDB (CAS No. 106-93-4) was obtained from the National Institute of Environmental Health Sciences' chemical repository at Radian Corporation,
Austin, TX.
Test animals
- Species:
- mouse
- Strain:
- other: Male DBA/2J and female C57BL/6J
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Male DBA/2J and female C57BL/6J mice were obtained from the Jackson Laboratory.
- Age at study initiation: Males: 9 weeks; Females: 12-16 weeks.
- Weight at study initiation: nda
- Assigned to test groups randomly: Randomly sorted by weight.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Physiological saline.
- Details on exposure:
- EDB in physiological saline.
- Duration of treatment / exposure:
- Single intraperitoneal (i.p) injection.
- Frequency of treatment:
- Single intraperitoneal (i.p) injection.
- Post exposure period:
- Duration not reported. Offspring sacrificed at 10-12 weeks.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 40 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control substance: Procarbazine
- Justification for choice of positive control(s): Previous studies have shown that procarbazine injected intraperitoneally in the mouse at doses of 400 mg/kg induces a high percentage of dominant lethal mutations.
- Route of administration: intraperitoneal (i.p.) injection
- Doses / concentrations: 400 mg/kg (body weight)
Examinations
- Tissues and cell types examined:
- All females were killed by cervical dislocation and dissected approximately 12 days following removal from the breeding cage and presumptive
mating. The dominant lethal test was based on the following parameters: "Each female was scored for pregnancy and for total number of implants, as comprised by live implants, early fetal deaths, and late fetal deaths. Early fetal deaths are brown or black, containing necrotic and hemorrhagic material but no embryo; contrastingly, late fetal deaths are seen as implantation sites containing a subnormal fetus and placenta which may be white or pale" - Details of tissue and slide preparation:
- nda
- Evaluation criteria:
- The dominant lethal test was based on the following parameters: "Each female was scored for pregnancy and for total number of implants, as comprised by live implants, early fetal deaths, and late fetal deaths. Early fetal deaths are brown or black, containing necrotic and hemorrhagic material but no embryo; contrastingly, late fetal deaths are seen as implantation sites containing a subnormal fetus and placenta which may be white or pale"
- Statistics:
- Statistical analysis of the dominant lethal test was carried out using one-sided Mann-Whitney U Tests and pooled two sample t-tests to compare
the ratio of frequencies of early deaths in the treated and solvent control groups for each week of mating.
Comparisons of pregnancy rates in the treated groups and the solvent control group were made by a one-sided Fisher exact test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The dominant lethal studies showed no effect on the fertility of treated males (Table 2), nor any effects on the development of their progeny.
- Results for the Electrophoretic study:
Fertility of treated males remained normal throughout the breeding period. A total of 49 599 loci were screened from the treated group. As illustrated by the data, EDB produced negative results in the mouse electrophoretic specific- locus test, No mutations were detected among 1503 offspring recovered from the treated group or from the 335 solvent control animals.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The dominant lethal studies showed no effect on the fertility of treated males, nor any effects on the development of their
progeny.
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