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Diss Factsheets
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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female young adult New Zealand White rabbits were used in this study. The body weights at dosing ranged from 2.8-3.2 Kg for the males and from 2.7-3.2 Kg for the females. The terminal weights ranged from 3.1-3.4 Kg for the males and 2.9-3.4 Kg for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 69-72° F with a relative humidity of 37-66%.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The back of each animal was shaved the day before administration of the test substance. The dose was applied evenly with a 10 cc syringe to the back of each animal followed by a layer of 8-ply gauze to cover the test site. The gauze was covered by a rubber dam and the anterior and posterior edges of the dam securely taped. A plastic Elizabethan collar was placed on each animal to prevent oral ingestion of the test substance and mechanical irritation of the test site. Following an approximately 24 hour exposure period, the collars, dam, and gauze were removed and the residual test substance wiped from the site.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived treatment.
- Clinical signs:
- other: The following clinical observations that may have been caused by treatment were noted in one or more animals: soft stool, decreased fecal output, decreased food consumption, and nasal discharge.
- Gross pathology:
- No gross pathological changes were noted at necropsy.
Any other information on results incl. tables
No abnormal clinical observations or gross pathology were noted on the animals that lost weight.
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 following acute dermal application was greater than 2000 mg/kg for male and female New Zealand white rabbits. These findings do not warrant classification of MRD-94-953 as an acute oral toxicant 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 via occlusive dermal application for 24 hours to New Zealand white rabbits (5 males and 5 females/dose) at 2000 mg/kg to assess the acute dermal toxicity. Animals were observed daily for 14 days post dosing. No overt signs of toxicity were apparent. No mortality was observed. All animals which survived to study termination were free of abnormalities at postmortem examination. A single female rabbit lost 0.1 kg body weight between days 7 and 14. The LD50 for 1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13-Rich greater than 2000 mg/kg. These findings do not warrant classification of 1,4-Benzenedicarboxylic Acid, Di-C11 -14 -Isoalkyl Ester, C13-Rich as an acute dermal toxicant 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.
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