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EC number: 284-366-9 | CAS number: 84852-53-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 10, 1990 - Sept 21, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to international guidelines and Good Laboratory Practise standards by an experienced testing laboratory.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- EC Number:
- 284-366-9
- EC Name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- Cas Number:
- 84852-53-9
- Molecular formula:
- C14H4Br10
- IUPAC Name:
- 1,2,3,4,5-pentabromo-6-[2-(2,3,4,5,6-pentabromophenyl)ethyl]benzene
- Details on test material:
- 96.3% Decabromodiphenyl ethane
3.6 % Dodecabromodiphenyl ethane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Per guidelines.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Once daily for 28 consecutive days for all groups followed by a 14 day withdrawal in subsets of the control and high dose groups only.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gravimetric
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (vehicle), 125 , 400 and 1,250 mg/kg
Basis:
- No. of animals per sex per dose:
- 12/sex/dose in the control and high dose groups.
6/sex/dose in the low and mid dose groups. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Animals were acclimated to the laboratory conditions prior to the start of the study. Animals, of the age specified in the guidelines, were randomly assigned to treatment groups such that mean body weights were similar at study initiation.
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- see below
- Sacrifice and pathology:
- see below
- Other examinations:
- see below
- Statistics:
- ANOVA with Dunnet's post test or nonparametric statistics as appropriate for the particular endpoint.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- see below
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see results
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No adverse effects were seen in rats treated orally at doses up to 1,250 mg/kg/day for 28 days. No rats died prior to scheduled sacrifice. Clinical signs were non-specific, low in incidence, non-dose-related and not related to test article administration. No test-article-related ocular lesions were detected on ophthalmic exam. No statistically significant differences were observed at any time point in mean body weight, body weight gain or food consumption between the control and low, mid and high dose groups. No treatment related effects were found on hematology, serum chemistry or urinalysis values. No gross lesions attributable to the test article were detected at either sacrifice. No biologically or toxicologically significant differences in absolute organ weight, organ to body weight or organ to brain weight were found at either sacrifice between treated and control groups. No treatment-related microscopic changes were found in any of the tissues evaluated from rats in the high dose group (adrenals, heart, kidneys, liver, mesenteric lymph node, parathyroids, spleen, and thyroid). The no-observed-effect-level (NOEL) was >= 1,250 mg/kg/d. The NOEL was based on the absence of toxicity at this dose as measured by: body weight, food consumption, body weight gain, hematology and serum chemistry values, urinalysis, ocular exam, gross necropsy results, organ weight, and light microscopic exam of selected tissues. This study was conducted according to OECD Guideline 407 and Good Laboratory Practices, and was reviewed as a part of the substance's registration in Japan.
Applicant's summary and conclusion
- Conclusions:
- The 28-d NOEL was >= 1250 mg/kgd, the highest dose tested.
- Executive summary:
No adverse effects were seen in rats treated orally at doses up to 1,250 mg/kg/day for 28 days. No rats died prior to scheduled sacrifice. Clinical signs were non-specific, low in incidence, non-dose-related and not related to test article administration. No test-article-related ocular lesions were detected on ophthalmic exam. No statistically significant differences were observed at any time point in mean body weight, body weight gain or food consumption between the control and low, mid and high dose groups. No treatment related effects were found on hematology, serum chemistry or urinalysis values. No gross lesions attributable to the test article were detected at either sacrifice. No biologically or toxicologically significant differences in absolute organ weight, organ to body weight or organ to brain weight were found at either sacrifice between treated and control groups. No treatment-related microscopic changes were found in any of the tissues evaluated from rats in the high dose group (adrenals, heart, kidneys, liver, mesenteric lymph node, parathyroids, spleen, and thyroid). The no-observed-effect-level (NOEL) was >= 1,250 mg/kg/d. The NOEL was based on the absence of toxicity at this dose as measured by: body weight, food consumption, body weight gain, hematology and serum chemistry values, urinalysis, ocular exam, gross necropsy results, organ weight, and light microscopic exam of selected tissues.
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