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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health Effects Test Guidelines: OPPTS 870.3550 Reproduction/ Developmental Toxicity Screening test, July 2000
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA test guidleine 40 CFR 799.9355 (comparable to OECD TG No. 421)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
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
- Details on test material:
- 99.4% purity dibromomethane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- see end point 7.8.1 for details
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- see end point 7.8.1 for details
- Details on study design:
- see end point 7.8.1 for details
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Offspring bodyweight, survival, growth and development were unaffected by maternal treatment at dosages of 50, 150 or 500 mg/kg/day. Necropsy findings among offspring did not indicate any effect of maternal treatment at dosages of 50, 150 or 500 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- The reproductive toxicity of dibromomethane was investigated in a reproductive and developmental toxicity screening test in rats (OECD TG No.421) (and OPPTS 8703550).
In this study, dibromomethane was administered via gavage to (10 animals/sex/dose at 0, 50, 150, or 500 mg/kg bw/day for 40 days.
No deaths were observed in either sex. There were no significant treatment-related clinical signs of toxicity.
At 50 or 150 mg/kg bw/day, mating performance, fertility and gestation length were unaffected by treatment. However, treatment at 500 mg/kg bw/day was
associated with an effect on mating performance (increased pre-coital interval) and a reduction in litter size at birth, most probably due to increased in-uteromortality. Treatment at 500 mg/kg/day did not adversely affect fertility, with 8/10 females achieving pregnancy. Necropsy did not indicate any effect of the
test material on adult animals. The NOAEL for reproductive and developmental toxicity was considered to be 150 mg/kg/day. - Executive summary:
Oral (Gavage) Reproduction/Development Toxicity Screening Test in the Rat (Dhinsa and Fulcher 2007) was conducted under GLP standards and in accordance with OECD TG for Testing of Chemicals No.421. (adopted 27 July 1996) and EPA Health Effects Test Guidelines: OPPTS 870.3550 (July 2000). The study was identified as a key study (klimisch rating 1).
The test material (99.4% purity, dibromomethane) was administered by gavage to three groups each of 10 male and 10 female Sprague-Dawley Crl:CD® (SD) IGS BR strain rats, at dose levels of 50, 150 and 500 mg/kg/day, for approximately forty days (two week maturation phase, pairing of maximum 14 days, gestation and early lactation).
A control group was similarly dosed with vehicle only (Polyethylene Glycol 400).
Clinical signs, bodyweight development, food and water consumption were monitored during the study. Animals were paired one male:one female 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 surviving females and offspring being killed on Day 5post partum. All animals were subjected to a gross necropsy examination and histopathological evaluation of reproductive tissues was performed.
Results: During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size, offspring weights and assessment of righting reflex. Offspring were killed on Day 5post partumand were subjected to a gross necropsy examination.
Offspring bodyweight, survival, growth and development were unaffected by maternal treatment at dosages of 50, 150 or 500 mg/kg/day. Necropsy findings among offspring did not indicate any effect of maternal treatment at dosages of 50, 150 or 500 mg/kg/day.
Litter responses:at 500 mg/kg bw/day, litter size was lower than control on Day 1 due to increased post-implantation loss; this loss probably representing death of the offspringin-utero.In addition, one female at this dosage was considered to have lost her litterin-utero. No similar treatment related effects were apparent for animals at 50 or 150 mg/kg bw/day.
At 50 or 150 mg/kg bw/day, offspring bodyweight on day 1 and subsequent survival, growth and development to Day 4 were unaffected by maternal treatment; lower litter weights at 500 mg/kg bw/day reflected the lower litter size. One control female and one female receiving 500 mg/kg bw/day showed total litter loss on Day 1post partum.
No Observed Adverse Effect Level’ (NOAEL) for develeopmental toxicity was not determined in the study. However, can be considered as < 500 mg/kg bw/day.
Conclusion
Treatment with dibromomethane at 500 mg/kg bw/day was associated with effect on mating performance and a reduction in litter size at birth, most probably due to increase inin-uteromortality. The ‘No Observed Adverse Effect Level’ (NOAEL) for reproduction observed in this study was considered to be 150 mg/kg/day.
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.