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EC number: 213-497-6 | CAS number: 959-26-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Distribution of Terephthalic Acid in Tissues
- Author:
- Hoshi, A., & Kuretani, K.
- Year:
- 1 968
- Bibliographic source:
- Chemical and Pharmaceutical Bulletin 16(1): 131-135
Materials and methods
- Objective of study:
- distribution
- Principles of method if other than guideline:
- The distribution of terephthalic acid in rat tissues was determined using radio-labelling.
- GLP compliance:
- no
- Remarks:
- predates GLP
Test material
- Reference substance name:
- Terephthalic acid
- EC Number:
- 202-830-0
- EC Name:
- Terephthalic acid
- Cas Number:
- 100-21-0
- Molecular formula:
- C8H6O4
- IUPAC Name:
- terephthalic acid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Details on exposure:
- Feed experiments: groups of rats were fed 0.5% TPA in the basal diet.
Gavage experiments: rats were given a single oral administration of 2% TPA in 0.5% sodium carboxymethylcellulose solution prepared with a glass homogeniser. - Duration and frequency of treatment / exposure:
- Feed experiments: Group a were fed the test diet for 1 day; Group B were fed the test diet for 3 days; Group C was fed the test diet for 3 days followed by the basal diet alone for 1 day.
Gavage experiments: Single oral administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 85 mg/kg bw (total dose)
- Remarks:
- Gavage experiments
- Dose / conc.:
- 0.5 other: % in diet
- Remarks:
- Feed experiments
- No. of animals per sex per dose / concentration:
- Feed experiments: 5 female rats/group.
Gavage experiments: 5 females rats/time point (six time points in total). - Control animals:
- no
- Details on study design:
- Feed experiments: each group of rats was sacrificed following completion of their respective feeding periods.
Gavage experiments: 5 rats per time point were sacrificed at 2, 4, 6, 8, 24 and 48 h after administration. - Details on dosing and sampling:
- In both experiments, 4 ml blood was drawn from the vena cava with a heparinized syringe under light ether anesthesia, and tissues were excised after the animals were sacrificed by bleeding from the carotid artery.
Treatment of samples: 0.1 ml whole blood was taken in a screw cap vial, washed twice with 5 ml of 0.9% NaCl solution and centrifuged. Plasma was separated by centrifuging 0.2 ml of whole blood.
Tissues were cut finely with scissors, an aliquot of which was weighed as follows: 100 mg of liver, spleen, bone (femur) and salivary gland, and 200 mg of kidney, lung, heart, brain, muscle (thigh), pancreas, uterus, adipose (white) tissue and skin. For the rest of the tissues, whole organs were used because of their small quantities available, such as 30-50 mg of ovary, 9-13 mg of thyroid land and 8-15 mg of pituitary gland.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not measured
- Details on distribution in tissues:
- Feed experiments: In group A, the content of TPA in the kidney and liver was considerably higher than other tissues. A moderate amount of TPA was detected in the plasma, and in all other tissues that levels were low. In group B, the content of TPA in the plasma was comparable to that found in group A, and the content in the other tissues followed the same distribution pattern as that seen in group A. In group C, TPA content had decreased rapidly in the tissues compared to groups A and B, with no TPA detected at all in many of the tissues.
Gavage experiments: The highest content of TPA was found 2 hours after administration in the plasma, kidney and liver. Overall a similar distribution pattern was observed following gavage administration compared to dietary administration.
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st: 1.2-3.3 h, tissues, gavage administration
- Toxicokinetic parameters:
- half-life 1st: 2.43 h (95% CI: 1.99-3.1 h), plasma, gavage administration
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Distribution of TPA in tissues of rats fed a diet containing 0.5% radio-labelled TPA
Tissue | TPA content (µg/g tissue; µg/ml plasma)a | ||
Group Ac | Group B | Group C | |
Plasma | 9.77±1.59 | 8.43±5.22 | 0.04±0.02 |
Kidney | 49.35±12.99 | 40.31±22.46 | 0.31±0.05 |
Liver | 22.67±8.78 | 15.77±7.45 | 0.09±0.05 |
Brain | 2.10±0.31 | 1.87±0.42 | 0.07±0.03 |
Skin | 3.85±1.45 | 4.75±2.97 | 1.20±0.51 |
Lung | 3.98±1.95 | 3.88±2.23 | 0 |
Pancreas | 2.22±0.85 | 4.64±3.90 | 0.22±0.08 |
Spleen | 1.36±0.73 | 1.29±0.69 | 0 |
Adipose tissue (white) | 1.05±0.68 | 2.28±20.9 | 0 |
Heart | 2.18±1.07 | 1.77±1.07 | 0 |
Muscle (thigh) | 0.39±0.12 | 0.84±0.44 | 0 |
Bone (femur) | 0.42±0.27 | 0.51±0.32 | 0 |
Blood cellb | 0.66±0.43 | 0.95±0.84 | 0 |
Uterus | 3.69±1.45 | 3.66±2.05 | 0.07±0.05 |
Ovary | 2.70±0.50 | 1.40±1.00 | 0 |
Salivary gland | 2.28±0.74 | 1.36±0.66 | 0.06±0.06 |
Thyroid gland | 2.90±0.80 | 2.80±0.80 | 0 |
Pituitary gland | 3.10±1.50 | 3.00±1.60 | 0 |
Adrenal gland | 1.80±0.60 | 1.30±0.80 | 0 |
a mean value ± SE; 5 rats per group
b corresponding to 1 ml of whole blood
c Group A: fed 0.5% TPA diet for 1 day; Group B: fed 0.5% TPA diet for 3 days; Group C: fed 0.5% TPA for 3 days followed by 1 day treatment-free recovery period.
Distribution of TPA in rat tissues following a single oral administration of 85 mg/kg bw
Tissue | TPA content (µg/g tissue; µg/ml plasma)aat hours post-administration | |||||
2 h | 4 h | 6 h | 8 h | 24 h | 48 h | |
Plasma | 10.38±1.74 | 6.75±2.05 | 2.96±0.32 | 2.38±0.37 | 0 | 0 |
Kidney | 58.52±10.71 | 25.71±4.60 | 15.74±3.03 | 8.54±1.67 | 0.41±0.04 | 0 |
Liver | 31.25±2.88 | 12.96±2.18 | 8.14±1.40 | 5.13±0.56 | 0.13±0.04 | 0 |
Brain | 0.98±0.05 | 1.22±0.07 | 1.17±0.11 | 1.32±0.08 | 0.07±0.01 | 0 |
Skin | 6.04±1.33 | 2.91±0.45 | 2.14±0.42 | 1.90±0.29 | 0.06±0.04 | 0 |
Lung | 4.19±0.34 | 1.72±0.40 | 1.34±0.40 | 0.63±0.13 | 0 | 0 |
Pancreas | 3.11±0.37 | 1.06±0.09 | 0.63±0.16 | 0.38±0.05 | 0 | 0 |
Spleen | 1.30±0.16 | 0.47±0.09 | 0.34±0.11 | 0.22±0.04 | 0 | 0 |
Adipose tissue (white) | 0.87±0.22 | 0.45±0.05 | 0.36±0.09 | 0.16±0.02 | 0 | 0 |
Heart | 2.53±0.41 | 0.84±0.19 | 0.61±0.19 | 0.29±0.05 | 0 | 0 |
Muscle (thigh) | 0.72±0.11 | 0.31±0.05 | 0.24±0.10 | 0.09±0.01 | 0 | 0 |
Bone (femur) | 0.41±0.14 | 0.12±0.04 | 0.10±0.04 | 0 | 0 | 0 |
Blood cellb | 0.43±0.07 | 0.32±0.13 | 0.18±0.06 | 0 | 0 | 0 |
Uterus | 5.67±1.31 | 2.15±0.68 | 1.70±0.54 | 0.70±0.17 | 0 | 0 |
Ovary | 4.40±0.80 | 1.50±0.10 | 1.10±0.40 | 0.70±0.20 | 0 | 0 |
Salivary gland | 3.16±0.68 | 1.58±0.33 | 1.00±0.08 | 0.81±0.22 | 0 | 0 |
Thyroid gland | 3.00±0.30 | 2.00±0.30 | 1.40±0.30 | 1.00±0.40 | 0 | 0 |
Pituitary gland | 3.10±0.40 | 2.20±0.60 | 1.10±0.30 | 0.90±0.10 | 0 | 0 |
Adrenal gland | 2.10±0.20 | 0.90±0.20 | 0.50±0.10 | 0.20±0.10 | 0 | 0 |
a mean value ± SE; 5 rats per group
b corresponding to 1 ml of whole blood
Applicant's summary and conclusion
- Conclusions:
- Low bioaccumulation potential based on study results
Terephthalic acid was eliminated rapidly from tissues and plasma, and did not accumulate in any tissues. - Executive summary:
The distribution of terephthalic acid (TPA) in the tissues of rats was determined using radio-labelling; terephthalic carboxyl-14C acid. Female Wistar King-A rats were fed a diet containing 0.5% TPA for 1 day (group A), 3 days (group B), or 3 days followed by a 1 day recovery period (group C). Rats were sacrificed at the end of the respective feeding periods and the tissues assayed for radioactivity to determine the TPA content. Another group of female rats was administered a single oral dose by gavage of 85 mg/kg bw radio-labelled TPA, and sacrificed at various intervals post-administration for determination of TPA content in the tissues.
In the rats fed TPA-diets, TPA content was highest in the kidney (40 -50 µg/g), liver (16 -23 µg/g) and plasma (8 -10 µg/ml). Content in the other tissues was low. A single administered dose was distributed rapidly in the tissues within 2 hours of administration, and the distribution pattern in the tissues was similar to that seen in the feeding study. The maximum content of TPA in the tissues was seen within 2 hours of administration, whereas in the brain the maximum content was seen 8 hours after adminstration.
Only small amounts of TPA remained in the tissues 24 hours after single administration, and 24 hours after completion of a 3 day feeding period.
The biological half life was calculated following the single gavage administration and found to be 1.2 - 3.3 hours in tissues, and 2.43 hours in plasma. It was concluded that terephthalic acid was eliminated rapidly from tissues and plasma, and did not accumulate in any of the tissues examined.
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