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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 416-740-6 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 401
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Limit dose reduced from 5000 mg/kg to 2000 mg/kg
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-740-6
- EC Name:
- -
- Molecular formula:
- Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)
- IUPAC Name:
- Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich
- Details on test material:
- Test article is a colorless homogeneous liquid. This material as stated in the Product Physical and Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female young adult Sprague-Dawley rats obtained from Taconic Farms (Germantown, N.Y.) were used in this study. The body weights at dosing ranged from 234-261 grams for the males and 186-221 grams for the females. The terminal weights ranged from 303- 359 for the males and 226-259 for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 69-74° F with a relative humidity of 38-62%.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Single dose of 100% test article was administered
- Details on oral exposure:
- All animals were fasted overnight and dosed via oral gavage. Body weights were recorded prior to fasting and on Days 0, 7, and 14.
The test article was dosed with a blunted needle attached to a 1 cc syringe. Food was returned to each animal immediately after dosing. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Signs of toxicity were recorded at approximately 0.5-, 1- and 4-hours after test substance administration and daily thereafter with the exception of weekends. The condition of each animal (live,dead,moribund) was checked at least once daily in the morning except on day 6 when they were checked in the afternoon. All animals were euthanized by overexposure to carbon dioxide and then necropsied at the termination (day 14) of the study.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived treatment with the test article.
- Clinical signs:
- other: The following clinical observations that may have been caused by treatment were noted in one or more animals: soft stool, chromorhinontea, and alopecia on both fore paws.
- Gross pathology:
- There were no gross pathological changes noted during necropsy that could be related to treatment
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich is >2000 mg/kg. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich for acute oral toxicity under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich was administered by oral gavage to 5 male and 5 female Sprague Dawley rats at the limit dose of 2000 mg/kg to assess the acute oral lethality. Clinical observations were made at 0.5, 1, 4 hours and daily thereafter exposure. No adverse clinical effects noted. At the end of the study, the LD50 was determined to be greater than 2000 mg/kg. This finding does not warrant the classification of
1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich
under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.