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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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). Limit test performed under GLP requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
- Principles of method if other than guideline:
- The test substance (a neat powder) was administered to the backs of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw and covered with an occlusive wrap. Prior to application, the backs were shaved and moistened with water. The test substance was left in contact with the skin for 24 hours and then removed. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied.
- GLP compliance:
- yes
- Limit test:
- 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:
- Purified terephthalic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Johnson Rabbit Ranch (Wilkinson, IN)
- Age at study initiation: approximately 3 months of age
- Weight at study initiation: 2.59 kg (males) and 2.45 kg (females)
- Housing: Individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm. Poly pads were placed in the pan below the stainless steel mesh floor of each animal cage to absorb liquids.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.7°C
- Humidity (%): 32%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Prior to application, the backs were shaved and moistened with water. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied.
TEST SITE
- Area of exposure: The shaved application site (approximately 240 cm2 on the back of each rabbit) was pre-moistened with water immediately prior to test article administration.
- % coverage: The test substance was covered with a 12.8 x 23.0 cm surgical dressing
- Type of wrap if used: Plastic film, secured by lint-free cloth and elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped gently with gauze and 0.9% saline to remove residual test article.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g
- For solids, paste formed: The shaved application site was pre-moistened with water immediately prior to test substance administration. - Duration of exposure:
- 24 hours
- Doses:
- 2 grams
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All test rabbits were observed approximately 3/4, 3-1/4, 4-1/4 and 5-1/4 hours after dosing and at least once per day for 14 days after removal of the wrappings.
- Necropsy of survivors performed: Yes, a limited gross necropsy was performed on all test animals.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Body weights were assessed at dosing, and on Days 7 and 14.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: The only clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females.
- Gross pathology:
- No gross pathological lesions attributable to treatment were evident in any of the rabbits at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rabbit dermal LD50 > 2000 mg/kg bw
- Executive summary:
The test substance (a neat powder) was administered to the backs of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw and covered with an occlusive wrap. Prior to application, the backs were shaved and moistened with water. The test substance was left in contact with the skin for 24 hours and then removed. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied. No deaths occurred during the study. The only clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females. Mean body weights increased during the study. No gross pathological lesions attributable to treatment were evident in any of the rabbits at necropsy. The dermal LD50 was greater than 2000 mg/kg bw.
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