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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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: longer than a one-generation (OECD 414)
- Type of information:
- experimental study
- Remarks:
- migrated data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Scientifically-sound study which precedes establishment of guidelines and GLP. Male rats were exposed for 115 days to the test substance before mating. This represents a longer premating exposure time compared to guideline studies, and thus represents an adequate assessment of male reproductive function after exposure.
- Justification for type of information:
- 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.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Data can be read-across to dimethyl isophthalate (DMIP) from dimethyl terephthalate (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. - Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Long-Evans rats were administered DMTP in corn oil mixed with food for 115 days. They were mated with females who had been fed the same diet for 1 week prior to mating. Females continued eating this diet throughout gestation, parturition and weaning (Postnatal day 21). Percentage of inseminations and pregnancies, average gestation time and litter size, mortalities and pup weight were recorded, along with gross observations of teratogenic effects in offspring.
- GLP compliance:
- no
- Limit test:
- no
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:
- solid: crystalline
- Details on test material:
- dimethyl terephthalate. No information on purity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male animals were placed in the protocol as weanlings.
Housed in wire-bottom cages, 5 per cage.
Water and the appropriate diet were available ad libitum.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Test material dissolved in corn oil, and mixed with basal diet of ground Purina Laboratory Chow.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Mazola corn oil
- Amount of vehicle (if gavage): 2.0% (w/w) corn oil in diet
- Purity: no information - Details on mating procedure:
- Males were mated with females who had been fed the same diet for 1 week prior to mating. The mating period was 1 week long, after which males were removed from the females and the diet changed to control diet for the remainder of their lives. Females continued eating the DMTP diet throughout gestation, parturition and weaning (Postnatal day 21).
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- PREPARATION OF DOSING SOLUTIONS:
Test material was added to the measured amount of corn oil and put into solution by adding 1000 g of chloroform and heating. This solution was added to the ground chow and homogenized using an automatic food mixer. The diets were spread on shallow, open trays to allow the chloroform to evaporate. A control diet was handled similarly but the addition of the test compound was omitted. - Duration of treatment / exposure:
- 122 days for males; 49 days for females.
- Frequency of treatment:
- daily
- Details on study schedule:
- There were 30 rats per dose group. At the beginning of the study, 10 animals of each group were randomly assigned to a group to be sacrificed on day 90. Another 15 animals were randomly selected for clinical chemistry and haemtological assessment at day 55 and every six months until sacrifice at 1 year. After 115 days, 5 animals of each dose group were placed with females for 1 week to allow mating. after which males were removed from the females and the diet changed to control diet for the remainder of their lives. Females continued eating the DMTP diet throughout gestation, parturition and weaning (Postnatal day 21).
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.25 % (w/w)
Basis:
- Remarks:
- Doses / Concentrations:
0.5% (w/w)
Basis:
- Remarks:
- Doses / Concentrations:
1.0% (w/w)
Basis:
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- There were no significant effects of exposure to 1% DMTP in the diet of rats. One treatment-related effect was reduced weight gain in the high dose males (386 g compared to 400 g in controls) at 91 days.
- Oestrous cyclicity (parental animals):
- No effect of treatement for 1 week prior to mating.
- Sperm parameters (parental animals):
- There was no adverse effect on the ability of males to inseminate females or for females to become pregnant.
- Litter observations:
- Pregnancy rate was at least 95%. There were no treatment effects on length of gestation or litter size. There was no mortality of young at birth, or during the period from birth to weaning.
- Postmortem examinations (parental animals):
- No effects
- Postmortem examinations (offspring):
- No effects
- Statistics:
- means, no standard deviation/standard error given. Differences were considered statistically significant at p < 0.05.
- Reproductive indices:
- No effects
- Offspring viability indices:
- No effects
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was reduced weight gain in the high dose males (386 g compared to 400 g in controls) at 91 days.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- There was reduced weight gain in the high dose males (386 g compared to 400 g in controls) at 91 days.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: % (w/w)in the diet.
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: 1% in the diet is approximately equal to 400 mg/kg bw/day.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a dose-dependent decrease in mean body weight of pups at weaning in the 1% and 0.5% groups (p < 0.05).
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
There was no treatment-associated mortality throughout the 115 day study in males, or in adults or offspring throughout the reproductive phase of the study. There was reduced weight gain in the high dose males (386 g compared to 400 g in controls). There were no toxicological effects on haematologic or clinical chemistry parameters. There was no effect on organ weights. Microscopic examination of tissues from all organ systems revealed no morphologic evidence of abnormalities which could be attributed to the compound. In the reproduction study, there was no adverse effect on the ability of males to inseminate females. The pregnancy rate was at least 95%. There were no treatment effects on length of gestation or litter size. There was no mortality of young at birth, or during the period from birth to weaning. No teratogenic effects were reported. There was a dose-dependent decrease in mean body weight of pups at weaning in the 1% and 0.5% groups (p < 0.05).
Applicant's summary and conclusion
- Conclusions:
- Dimethyl terephthalate was administered to male Long-Evans rats for 115 days at levels of 0.25, 0.5 and 1% (w/w) in the diet, prior to mating with females fed the diet for seven days. Pregnant females were maintained on the diet throughout gestation and through weaning on post-natal day 21. Males were assessed for chronic toxicity effects throughout their natural lifetime (up to 2 years), with the finding of no significant adverse effects (except for slightly lower body weight gain). There were no adverse effects of DMTP on male or female fertility or gestation, and no fetotoxicity or teratogenicity. The male and female reproductive NOAELs are 1% in the diet, equivalent to approximately 400 mg/kg bw/d. 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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