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EC number: 207-892-2 | CAS number: 499-80-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from European Commission, NTRL and OECD SIDS
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Reproductive toxicity study of CAS no 100-21-0
- Author:
- European Commission
- Year:
- 2 000
- Bibliographic source:
- European Commission – European Chemicals Bureau, 22–FEB–2000
- Reference Type:
- secondary source
- Title:
- A ninety day study of treephthalic acid (CAS no 100-21-0) ininduced urolithiasis and reproductive performance in westar and CD rats
- Author:
- NTRL
- Year:
- 1 982
- Bibliographic source:
- National Technical Reports Library (NTRL), OTS94820190, 1982
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report of Terephthalic Acid (TPA)
- Author:
- OECD SIDS
- Year:
- 2 001
- Bibliographic source:
- OECD SIDS, 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- One-generation reproduction toxicity study of Terephtalic acid in Rats
- GLP compliance:
- not specified
- Limit test:
- no
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:
- benzene-1,4-dicarboxylic acid
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:Terephthalic acid
Molecular Formula:C8H6O4
Molecular Weight:166.131 g/mol
SMILES notation: c1(C(O)=O)ccc(C(O)=O)cc1
Substance Type:Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical:Terephthalic acid
Molecular Formula:C8H6O4
Molecular Weight:166.131 g/mole
SMILES notation: c1(C(O)=O)ccc(C(O)=O)cc1
Substance Type:Organic
Physical State: Solid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Housing: Female were housing in a solid bottom cage
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: feed
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Two weeks - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 Days
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 15 mg/kg bw/day
- Dose / conc.:
- 62.5 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 500 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 120
0 mg/kg/day: 10 male, 10 female
15 mg/kg/day: 10 male, 10 female
62.5 mg/kg/day: 10 male, 10 female
250 mg/kg/day: 10 male, 10 female
1000 mg/kg/day: 10 male, 10 female
2500 mg/kg/day: 10 male, 10 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, Clinical sign, Body weight and weight gain, food consumption were examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Pup viability, body weight and sex distribution were examined
- Postmortem examinations (parental animals):
- Gross pathology was examined.
- Postmortem examinations (offspring):
- Gross pathology and histopathology was examined.
- Statistics:
- Not specified
- Reproductive indices:
- Mating performance, fertility index, lit.ter size, mating, gestation, lactation and post weaning periods was examined.
- Offspring viability indices:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Diarrhea was observed in some of the rats at 2500 mg/kg bw
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Five unscheduled deaths occurred between 4 and 13 weeks in animls at 2500 mg/kg bw
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-related decreases in body weight and weight gain were observed in all dose groups.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-related decreases in food consumption were observed in all dose groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on fertility and litter size were observed in treated rats.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Decrease in pup viability were observed at 1000 and 2500 mg/kg bw
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant decrease in body weight of pups were observed at 2500 mg/kg bw
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross anomalies were observed in pups.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No foetal malformations were observed.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw for P and 250 mg/kg bw for F1 generation when male and female Wistar rats were treated with Terephtalic acid orally in feed for 90 days.
- Executive summary:
In a One-generation reproduction toxicity study, Wistar male and female rats treated with Terephtalic acid in the concentration of 0, 15, 62.5, 250, 1000 and 2500 mg/kg/day orally in feed for 90 days. Diarrhea was observed in some of the rats at 2500 mg/kg bw. Five unscheduled deaths occurred between 4 and 13 weeks in animals at 2500 mg/kg bw. Dose-related decreases in body weight and weight gain and food consumption were observed in all dose groups. No effect on reproductive parameters such as fertility and litter size were observed in treated rats. No bladder stones were observed in dead animals. In addition, Decrease in pup viability and Significant decrease in body weight were observed at 1000 and 2500 mg/kg bw. No gross anomalies and fetal malformations were observed. Therefore, NOAEL was considered to be 1000 mg/kg bw for P and 250 mg/kg bw for F1 generation when male and female Wistar rats were treated with Terephtalic acid orally in feed for 90 days.
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