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EC number: 204-171-4 | CAS number: 117-08-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity studies of tetrachlorophthalic anhydride (CAS No. 117-08-8) administered by gavage to F344/N Rats and B6C3F1 Mice.
- Author:
- NTP
- Year:
- 1 993
- Bibliographic source:
- NTP Technical Report Series No 28.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- No functional observations and ophthalmological examinations
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Tetrachlorophthalic anhydride
- EC Number:
- 204-171-4
- EC Name:
- Tetrachlorophthalic anhydride
- Cas Number:
- 117-08-8
- Molecular formula:
- C8Cl4O3
- IUPAC Name:
- tetrachloro-1,3-dihydro-2-benzofuran-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): Tetrachlorophthalic anhydride
- Analytical purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratorles
- Age at study initiation: 3-4 weeks
- Housing: 5 per cage
- Diet (e.g. ad libitum): NIH-07 Open Formula mash diet
- Water (e.g. ad libitum): city water
- Acclimation period: 12-16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose formulations were prepared weekly by mixing TCPA in corn oil (w/w). Before mixing, TCPA was ground and sieved, then weighed and added to a beaker containing the required amount of corn oil, the corn oil was magnetically stirred during the addition. Formulations were stored at approximately 4±3 °C and were discarded 7 days after the date of preparation.
VEHICLE
- Justification for use and choice of vehicle (if other than water): because of limited solubility of TCPA in water
- Concentration in vehicle: 0, 20.3, 40.1, 78.6, 15 1.2, or 280.9 mg/g in corn oil
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 94, 187, 375, 750, 1500 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: at study initiation, weekly thereafter, and at necropsy
FOOD CONSUMPTION:
- Food consumption for each cage (5 rats/cage): at weekly interval
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of the study
- Anaesthetic used for blood collection: Yes (CO2)
- Animals fasted: No data
- How many animals: all
- Parameters checked: Erythrocyte count (RBC), hematocrit, hemoglobin concentration (HGB), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), and leukocyte count (WBC), leukocyte differential counts, platelet counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: days 6, 20, and at study termination
- Animals fasted: No data
- How many animals: animals in the 0, 94, 375 and 1500 mg/kg bw
- Parameters checked: alanine
aminotransferaso (ALT). albumin, creatinine, y-glutamyltransterase (GGT), glucose, and urea nitrogen (UN).
OTHER: Male rats dosed with 0, 94, 375, or 750 mg/kg bw were evaluated for necropsy body and reproductive tissue weights and spermatozoal data. Female rats dosed with 0, 94, 375, or 1500 mg/kg bw were evaluated for necropsy body weight, estrous cycle length, and the percent of cycle spent in the various stages. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
In addition to detailed necropsy examination, following tissues were examined microscopically: adrenal glands, bone (femur, sternebrae, or vertebrae with marrow) brain (3 sections), clitoral and preputial glands, esophagus, heart, intestine (large cecum, colon, rectum, small duodenum, jejunumn, ileum), kidneys, liver, lungs and mainstem bronchi, lymph nodes (mandibular and mesenteric), mammary glands (including surface skin), nasal cavity and turbinates (3 sections), ovaries, pancreas, parathyroid glands, pituitary gland, prostate gland, salivary glands, seminal vesicles, spinal cord and sciatic nerve (if neurologic signs were present), spleen, stomach (forestomach and glandular stomach), testis with epididymis, thymus, thyroid gland, trachea, urinary bladder, and uterus.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: Treatment-related deaths occurred at 1500 mg/kg bw (5/10 males; 1/10 females) and 750 mg/kg bw (1/10 females). No compound-specific clinical signs of toxicity were observed at any test level in male animals. Urine staining in most females in the 750 and 1500 mg/kg bw groups and diarrhea in all females in the 1500 mg/kg bw group were attributed to treatment with TCPA.
BODY WEIGHT AND WEIGHT GAIN: Mean final body weights and weight gains were notably reduced in groups of male rats given 375, 750 and 1500 mg/kg bw and in all female treated groups. Final weight relative to vehicle controls in the males of the 94, 187, 375, 750, 1500 mg/kg bw dose groups were 94, 97, 89, 90 and 86 %. Similarly, final weight relative to vehicle controls in the females of the 94, 187, 375, 750, 1500 mg/kg bw dose groups were 91, 92, 90, 90 and 90 %.
FOOD CONSUMPTION : All groups (males and females) at all treatment levels exhibited decreased feed consumption compared to controls. In males, these decreases were dose related, and the average feed consumption of the 1500 mg/kg bw group was 12% lower than that of the controls.
HAEMATOLOGY: no clinical significant effects were observed
CLINICAL CHEMISTRY: no clinical significant effects were observed
ORGAN WEIGHTS: Absolute and relative kidney weights were increased in a dose-dependent manner to female rats while males were significantly increased (relative wt) at 187 mg/kg bw and higher. Other changes (spleen, thymus and liver) were either small, inconsistent or attributed to the marked decrease in body weights exhibited, and thus were not considered treatment-related
GROSS PATHOLOGY: No gross lesions attributable to treatment were observed at necrospy.
HISTOPATHOLOGY: NON-NEOPLASTIC: Treatment-related microscopic lesions were identified in the kidney of male and female rats from all test groups, and consisted of renal tubular degenerative changes. These changes involved epithelial necrosis at higher dose levels and tubular dilation at lower dose levels. No other microscopic findings attributable to treatment were found.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 94 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 94 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: microscopic changes in kidney
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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