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EC number: 200-824-2 | CAS number: 74-95-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- DATA ADEQUACY ASSESSMENT Dibromomethane, CAS No. 74-95-3
- Author:
- Environmental Science Center SRC, Inc.
- Year:
- 2 010
- Bibliographic source:
- U.S. Environmental Protection Agency
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibromomethane
- EC Number:
- 200-824-2
- EC Name:
- Dibromomethane
- Cas Number:
- 74-95-3
- Molecular formula:
- CH2Br2
- IUPAC Name:
- dibromomethane
1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley Crl:CD (SD) IGS BR rats obtained from Charles River (UK) Limited, Margate, Kent; 268 – 336g (males); 176 – 226g (females) and approximately 8 weeks old at the start of treatment
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 400
- Details on exposure:
- Animals were exposed during a two-week maturation phase, pairing, gestation, and early lactation.
- Details on mating procedure:
- Pairing of animals within each dose group was undertaken on a one male: one female basis on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation.
- Duration of treatment / exposure:
- 40 days
Doses / concentrations
- Remarks:
- 0(control.),50,150,500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10/sex(group
- Control animals:
- yes
- Details on study design:
The test material was administered by gavage to three groups each of ten male and ten female Sprague-Dawley Crl:CD® (SD) IGS BR strain rats, for approximately forty days (to include a two week maturation phase, pairing, gestation and early lactation) at dose levels of500, 150 and 50 mg/kg/day . A control group of ten males and ten females was similarly dosed with vehicle alone (Polyethylene glycol 400).
Clinical signs, bodyweight development, food and water consumption were monitored during the study.
Pairing of animals within each dose group was undertaken on a one male: one female basis on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation.
During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size, offspring weights and assessment of righting reflex.
Surviving males were terminated on Day 43 of the study, with all the surviving females and offspring being killed on Day 5 post partum .
All animals were subjected to a gross necropsy examination and histopathological evaluation of reproductive tissues was performed.
.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- ca. 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other:
- Remarks on result:
- other: highest dose tested
- Dose descriptor:
- LOAEL
- Remarks:
- systemic toxicity
- Effect level:
- ca. 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: (based on reduced body weight gain and food conversion efficiency in dams during gestation and lower food intake in dams during lactation
- Remarks on result:
- other: highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: systemic toxicity
- Remarks on result:
- other:
- Dose descriptor:
- LOAEL
- Remarks:
- reproductive/developmental toxicity
- Effect level:
- ca. 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: increased pre-coital interval, reduced litter size, and increased post-implantation loss
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive/developmental toxicity
- Effect level:
- ca. 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: on increased pre-coital interval, reduced litter size, and increased post-implantation loss)
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- >= 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- other: post implantation loss
Any other information on results incl. tables
One male, receiving 500 mg/kg/day, was killed in extremis on Day 2 of the study and one control female was found dead on Day 41 of the study; neither of these death were considered to be a consequence of treatment.
Applicant's summary and conclusion
- Conclusions:
- Treatment with Dibromomethane at 500 mg/kg/day was associated with a clear effect on mating performance and a reduction in litter size at birth, most probably due to increased in-utero mortality. The `No Observed Adverse Effect Level' (NOAEL) for reproduction observed in this study was considered to be 150 mg/kg/day.
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