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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-829-5 | CAS number: 100-20-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- This study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions). The study, if used in support of terephthalic acid, has a reliability of 1 (reliable without restriction). Recent study performed to appropriate guidelines under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- no
- GLP compliance:
- yes
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
- Details on test material:
- The unlabelled test substance used was terephthalic acid;
- Molecular weight; 166
-Colour; White
-Physical State; Solid
-Batch HHAS116
-Purity (%w/w) 99.9%
The radiolabelled test substance used was;
Source; Amersham
CTL test substance reference number; Y00751/006
Specific activity; 4.51 GBq/mmol; 26.6 MBq/mg
Radiochemical purity; 99.2%
Storage conditions; -20 degC.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The test animals were obtained from Charles River. At the time of dosing, the mice were required to be 27-32 g in weight.
The animals were housed up to 3 per cage, sexes separately, in multiple mouse racks. Diet was supplied by Special Diet Services Ltd, Stepfield, Witham, Essex and mains water supplied by plastic water bottles were available ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature 22 ±3 °C
- Humidity 30-70%
- Air changes (per hr): at least 15 changes/hour
- Photoperiod (hrs dark / hrs light):Artificial giving 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Each mouse was given a single intraperitoneal dose of 800 mg [14C]-terephthalic acid/kg.
The dose preparation was formulated by mixing a total weight of 756.2 mg terephthalic acid, including 6.536 MBq of radiolabelled test substance in an agate pestle and mortar bowl. The resulting material was then suspended in the dose vehicle to give 9.4456 g of dose preparation. Triplicate aliquots of each dilution were taken and analysed by liquid scintillation. - Duration and frequency of treatment / exposure:
- Single i.p. dose
Doses / concentrations
- Dose / conc.:
- 800 other: mg [14C]-terephthalic acid/kg
- No. of animals per sex per dose / concentration:
- 19 males mice were used (single dose level)
- Control animals:
- no
- Positive control reference chemical:
- Not applicable
- Details on study design:
- A single intraperitoneal dose of 800 mg [14C]-terephthalic acid/kg was administered to a group of 18 male mice. Sub-groups of three mice were terminated at 2, 4, 6, 12, 24 and 48 hours after dosing and blood and tissue samples taken.
- Details on dosing and sampling:
- A single intraperitoneal dose of 800 mg [14C]-terephthalic acid/kg was administered. Sub groups of three animals were terminated at 2, 4, 6, 12, 24 and 48 hour after dosing and blood and tissue samples taken.
Triplicate weighed aliquots of the dose preparation were taken before during and after dosing and diluted volumetrically in DMSO:methanol:water (7:2:1). Triplicate aliquots of each dilution were then taken and analysed by liquid scintillation counting. - Statistics:
- Means and standard deviations are reported.
Results and discussion
- Preliminary studies:
- No preliminary studies.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Rapid and extensive; > 80%, based on the level of urinary excretion.
- Details on distribution in tissues:
- Highest in the kidney two hours after dosing: 563 μg equiv/g (~ 1% of administered dose). Concentration in blood, plasma and bone marrow at two hours was 167, 221, and ≤40 μg equiv/g, respectively. Bone contained 74 μg equiv/g. Group mean concentrations of radioactivity in all other tissues measured ≤40 μg equiv/g.
- Details on excretion:
- Rapid and by 48 hours only the brain contained radioactivity above the limit of detection. 92% excreted in urine and faeces (urinary excretion, plus cage wash: 81%; faecal excretion:11%). Radioactivity in gastrointestinal tract contents at termination <0.1%.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- sulphate conjugate of terephthalic acid
Any other information on results incl. tables
Absorption was rapid and extensive and is estimated to be in excess of 80%, based on the level of urinary excretion.
The highest tissue concentration was found in the kidney two hours after dosing; 563 μg equiv/g representing approximately 1% of the administered dose. At the same time point the concentration of radioactivity in blood and plasma was 167 and 221 μg equiv/g respectively. Bone contained the next highest concentration of radioactivity; 74 μg equiv/g. Bone marrow was difficult to isolate from mouse femur but a sample isolated 2 hours after dosing showed a concentration of 92 μg equiv/g. Group mean concentrations of radioactivity in all other tissues measured was 40 μg equiv/g or less.
Elimination of radioactivity from the tissues was rapid and by 48 hours after dosing only the brain contained radioactivity above the limit of detection.
Over 48 hours, male mice excreted mean totals of approximately 92% of administered radioactivity in urine and faeces. Urinary excretion, plus cage wash, accounted for a mean total of 81% and faecal excretion for 11%. The percentage of radioactivity present in the gastrointestinal tract contents at termination was less than 0.1%.
The single metabolite was identified as the sulphate conjugate of terephthalic acid. The HPLC radiochromatogram of the pooled urine sample and cage wash contained a single, broad peak eluting at approximately 10 minutes. The negative mode mass spectra of this peak contained a base peak which was also the molecular ion [M-1] at 245 m/z.
Table 1 Excretion of Radioactivity by Male Mice
|
Table 2 Concentration of Radioactivity in the Blood following a Single Oral Dose of 800 mg of14C Terephthalic Acid/kg
|
Table 3 Concentration of Radioactivity in Tissues of the Male Mouse following a Single Oral Dose of 800 mg of14C Terephthalic Acid/kg
|
Applicant's summary and conclusion
- Conclusions:
- No bioaccumulation potential based on study results. The test substance was extensively absorbed into systemic circulation following the administration of a single intraperitoneal dose and widely distributed to all tissues including bone and bone marrow and was rapidly excreted via urine as the sulphate conjugate.
- Executive summary:
A single intraperitoneal dose of 800 mg [14C]-test substance/kg bw was administered to a group of 18 male CD-1 mice. Urine and faeces were collected. Sub-groups of three mice were terminated at 2, 4, 6, 12, 24 and 48 hours after dosing. At each time interval, blood and tissue samples were taken.
The administered dose was extensively absorbed into systemic circulation, widely distributed and rapidly excreted. The major route of excretion was via urine, which accounted for at least 70% of the administered dose within 24 hours after dosing. A large amount of radioactivity was also recovered from the floor of the cage which is most likely to be from urinary origin. In total, approximately 80% of the administered dose was estimated to have been excreted via urine. The highest tissue concentration of radioactivity was detected in the kidney, reflecting the extensive urinary excretion. Some radioactivity was present in the bone marrow at 2 hours after dosing, but by 4 hours it was at levels below the calculated limit of detection. Intact bone samples (femur) contained higher concentrations of radioactivity than most of the tissues that were analysed and it is considered that given the structure of bone and the timescales of the experiment, this radioactivity must be present mainly in the bone marrow. Radioactivity in all tissues declined rapidly and by 48 hours after dosing most were below the level of detection indicating that there is no potential for accumulation. Analysis of urine showed the presence of a single radiolabelled peak which was identified as the sulphate conjugate of the acid moiety.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)