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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-436-5 | CAS number: 77098-07-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- various
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Adequate data on structural analogues is available. See Section 7.12. "Additional Toxicological Data".Read across, rather than actual data, was used for this endpoint. The studies cited in Section 7.12 were previously screened in the OECD SIDS or U.S. National Institute of Health program,s and/or performed by the U.S. National Cancer Institute or U.S. National Toxicology Program or available in the open literature.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Tetrabromophthalic anhydride [CASRN 632-79-1] Review of the toxicological literature,
- Author:
- Tice
- Year:
- 1 999
- Bibliographic source:
- http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/Tetrabromophthalic.pdf, pp. 1-15 (See Appendix 6.2).
- Reference Type:
- publication
- Title:
- Bioassay of phthalic anhydride for possible carcinogenicity CAS No. 85-44-9
- Author:
- Anonymous
- Year:
- 1 979
- Bibliographic source:
- National Cancer Institute, Carcinogenesis, Technical Report Series No. 159, pp. 1-107 (See Appendix 6.3)
- Reference Type:
- publication
- Title:
- Toxicokinetics of phthalic acid: the common final metabolite of phthalic acid esters in rats,
- Author:
- Lim et al
- Year:
- 2 007
- Bibliographic source:
- JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH, PART A, Vol. 70, pp. 1344-1349.
- Reference Type:
- publication
- Title:
- NTP Technical Report on the Toxicology and Carcinogenesis Studies of Diallylphthalate (CAS No. 131-17-9) in F344/N Rats (Gavage Studies),
- Author:
- Anonymous
- Year:
- 1 985
- Bibliographic source:
- NATIONAL TOXICOLOGY PROGRAM TECHNICAL REPORT SERIES NO. 284, pp. 1-154 (See Appendix 6.4).
- Reference Type:
- other: OECD SIDS
- Title:
- OECD SIDS 1,2-Dihydroxypropane CAS: 57-55-6,
- Author:
- Anonymous
- Year:
- 2 001
- Bibliographic source:
- UNEP PUBLICATIONS, pp. 1-166, at p. 4 (See Appendix 6.5).
- Reference Type:
- other: OECD SIDS
- Title:
- OECD SIDS Initial Assessment Profile for Ethylene Glycols Category, pp. 1-4,
- Author:
- Anonymous
- Year:
- 2 004
- Bibliographic source:
- http://cs3-hq.oecd.org/scripts/hpv/ChemGroup.asp
- Reference Type:
- other: ATSDR
- Title:
- Toxicological profile for di(2-ethylhexyl) phthalate,
- Author:
- Anonymous
- Year:
- 2 002
- Bibliographic source:
- U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE, AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY, pp. 1-291
- Reference Type:
- other: EPA science policy
- Title:
- Proposed OPPTS science policy: PPARa-mediated hepatocarcinogenesis in rodents and relevance to human health risk assessments,
- Author:
- anonymous
- Year:
- 2 003
- Bibliographic source:
- OFFICE OF PREVENTION, PESTICIDES & TOXIC SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY, Washington, D.C. 20460, pp. 1-39.
- Reference Type:
- other: IARC
- Title:
- Peroxisome proliferation and its role in carcinogenesis: Views and expert opinions of an IARC working group, Lyon, 7-11 December 1994
- Author:
- Anonymous
- Year:
- 1 994
- Bibliographic source:
- IARC TECHNICAL PUBLICATION NO. 24, http://monographs.iarc.fr/ENG/Publications/techrep24/IARCrep24.pdf
- Reference Type:
- other: OECD SIDS
- Title:
- OECD SIDS Initial Assessment Profile for High Molecular Weight Phthalate Esters (HMWPE) Category, pp. 1-6,
- Author:
- anonymous
- Year:
- 2 004
- Bibliographic source:
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) tetrabromophthalate
- EC Number:
- 247-426-5
- EC Name:
- Bis(2-ethylhexyl) tetrabromophthalate
- Cas Number:
- 26040-51-7
- IUPAC Name:
- bis(2-ethylhexyl) 3,4,5,6-tetrabromophthalate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 200, 2000, 20000 ppm diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent no treatment
- Positive control:
- Di(2-ethylhexyl)phthalate at a dose of 15000 ppm was included as a positive control (rats 5/sex/group)
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see below
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
see below
Applicant's summary and conclusion
- Conclusions:
- The NOEL in this 28 d rat study was 2000 ppm in the diet.
- Executive summary:
Di(2-ethylhexyl)-3,4,5,6-tetrabromophalate (DEHTBP) is a brominated form of di(2-ethylhexyl)phthalate. DEHTBP has been evaluated in a 28-day dietary feeding study (rats 10/sex/dose group for DEHTBP) with dose levels of 0, 200, 2000, or 20000 ppm.Di(2-ethylhexyl)phthalate at a dose of 15000 ppm was included as a positive control (rats 5/sex/group) to evaluate the potential of DEHTBP to induce reproductive toxicity. The study was conducted in accordance with international guidance for performing 28-day repeated dose studies and was compliant with Good Laboratory Practice standards. Slight body weight decreases was observed in high dose DEHTBP females (91% of controls), along with a decrease in alanine aminotransferase activity (p<0.05). Also observed in high dose females were decreased calcium and phosphorous levels. There were no other adverse effects observed for hematology, clinical chemistry, urinalysis, organ weights, gross or microscopic analyses in male or female rats. Electron microscopy of livers from DEHTBP-treated animals was negative for peroxisome proliferation, a marker of PPARa. The positive control produced marked signs of toxicity in stark contrast to the negative control and DEHTBP test groups. The study authors reported a no-observed-adverse-effect level of 2000 ppm.
The above study with DEHTBP demonstrates that bromination of di(2-ethylhexyl)phthalate at the 3, 4, 5, and 6 position prevents the reproductive toxicity observed with di(2-ethylhexyl)phthalate in rodents. There are several possible explanations for this including: 1) DEHTBP may be poorly absorbed compared to di(2-ethylhexyl)phthalate; 2) if absorbed, DEHTBP or its metabolites may not act as an PPARaagonists; or 3) if absorbed, DEHTBP may not cross the blood:testes barrier. Regardless, DEHTBP provides a worse case scenario of the potential for an esterified form of 3,4,5,6-tetrabromophthalic acid to induce reproductive toxicity. These findingsare important for a structure activity comparison to the Reference Substance and the UVCB product because they demonstrate that bromination of a chemical shown to cause reproductive toxicity in rodents (i.e., di(2-ethylhexyl)phthalate) prevents that outcome. Because the reproductive toxicity of phthalate esters are associated with molecules that contain a 4 to 6 carbon linear or branched backbone,the absence of reproductive toxicity findings with DEHTBP, as well as, the absence of 4 to 6 carbon linear or branched aliphatic side chains in the Reference Substance and the UVCB product support that neither is a candidate for inducing reproductive toxicity.
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.