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EC number: 215-951-9 | CAS number: 1459-93-4
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, no data on GLP
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl terephthalate
- EC Number:
- 204-411-8
- EC Name:
- Dimethyl terephthalate
- Cas Number:
- 120-61-6
- Molecular formula:
- C10H10O4
- IUPAC Name:
- dimethyl terephthalate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: starch mucilage, 5 ml/kg body weight
- Duration of treatment / exposure:
- 10 days, from gestation day 7 to 16.
- Frequency of treatment:
- once daily
- Duration of test:
- through mating and gestation, termination at day 21
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight/day
Basis:
- No. of animals per sex per dose:
- 20 females per treatment group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Behaviour, general condition, food consumption and maternal body weight gain were checked during the study. The dams were sacrificed on day 21 of gestation, and caesarean section was performed and the numbers of corpora lutea, implantations, early and late resorptions, live and dead foetuses were determined. Placental weights and diameters of foetal resorptions were recorded. The pregnant females were necropsied and their organs macroscopically examined. The scope of foetal examinations encompassed determinations of sex, weight, crown-rump length, signs of life, appearance and externally visible abnormalities and, following appropriate preparation and staining, skeletal and visceral anomalies.
Examinations
- Maternal examinations:
- Behaviour, general condition, food consumption, placental and maternal body weight gain were checked during the study. The pregnant females were necropsied and their organs macroscopically examined.
- Ovaries and uterine content:
- The numbers of corpora lutea, implantations, early and late resorptions were assessed.
- Fetal examinations:
- The scope of foetal examinations encompassed determinations of sex, weight, crown-rump length, signs of life, appearance and externally visible abnormalities and, following appropriate preparation and staining, skeletal and visceral anomalies.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- other: No adverse effects were noted in any parameter at the single dose of 1000 mg/kg bw/d.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Foetuses obtained from the treated group were nomally developed and exhibited no externally visible abnormalities or variation or anomalies or variations of the internal organs or skeleton which could have been due to treatment with terephthalic acid dimethyl ester. The NOAEL was 1000 mg/kg body weight/d with regard to maternal toxicity and embryotoxicity/foetoxicity in the rat.
Applicant's summary and conclusion
- Conclusions:
- Dimethyl terephthalate, at 1000 mg/kg bw/d in a starch vehicle, was administered to female Wistar rats during gestation days 7 to 16. Treatment had no adverse effect on either general maternal health or intrauterine development. The NOAEL was 1000 mg/kg body weight/d for both maternal toxicity and embryotoxicity/fetoxicity. Data can be read-across to dimethyl isophthalate from DMTP, based on common functional groups. The substances are isomers. The similarities in structure are likely to apply to metabolites as well, with DMIP breaking down to isophthalic acid, just as DMTP is known to break down to terephthalic acid; these are isomers. Similar structures and similar break-down products for the two substances is the basis for the reading-across of data for this endpoint. This is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
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