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EC number: 251-118-6 | CAS number: 32588-76-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed prior to international guidelines and GLPs. The parameters investigated largely conform to current methodologies. The lack of adverse effects is consistent with the lack of toxicity observed in modern prenatal developmental studies in 2 species.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
- EC Number:
- 251-118-6
- EC Name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
- Cas Number:
- 32588-76-4
- Molecular formula:
- C18H4Br8N2O4
- IUPAC Name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- daily for 90 days followed by 46 d recovery period
- Frequency of treatment:
- daily in the feed for 90 days followed by 46 d recovery period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.01, 0.1, 1% of the diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15/sex/group
- Control animals:
- yes, concurrent no treatment
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:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- 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
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- dermal irritation
- food consumption and compound intake
- food efficiency
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- neuropathology
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 ppm
- Treatment related:
- no
- Dose response relationship:
- no
- Relevant for humans:
- no
Any other information on results incl. tables
See attached background material for Tables of Results.
Applicant's summary and conclusion
- Conclusions:
- The 90-day NOEL was 1% of the diet or approximately 1000 mg/kg bw.
- Executive summary:
EBTBP was administered to four groups of Sprague Dawley rats (n=15/sex/group) at 0, 0.01, 0.1 and 1.0% of the diet for 90 days followed by 46 days during which the rats were fed control diet. No changes in hematology or serum chemistry values related to treatment were detected on study days 0, 45, 92. No effect of treatment was found on urinalysis (d 0, 45 and 90). The mean relative and absolute organ weights of the liver, kidney, heart, and thyroids from the control and 1.0% groups were statistically comparable. Several animals died on test from non-test article related causes (most deaths were related to collection of blood for hematology and serum chemistry evaluations). Gross necropsy from animals dieing on test and sacrificed on days 92, 134, 135 and 136 revealed no test article-related gross lesions. No test article related lesions were detected on histopathology. The 90-day NOEL was 1% of the diet. This is estimated to be ~ 1,000 mg/kg/d using the assumption of consumption of 25 g diet per 250 g rat per day. This study was performed prior to the adoption of Good Laboratory Practices or EPA/OECD guidelines.
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