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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of tetrachlorophthalic anhydride on hepatic microsomal metabolism in rats and mice.
- Author:
- Ridley WP, Warren J
- Year:
- 1 988
- Bibliographic source:
- J Toxicol Environ Health. 24: 217-227
Materials and methods
- Objective of study:
- other: hepatic microsomal metabolism
- Principles of method if other than guideline:
- The capacity for induction of microsomal metabolic enzymes by tetrachlorophthalic anhydride (TCPA) was evaluated in male Sprague-Dawley rats. The rats (6/dose group) were orally dosed for 7 days with the test substance suspended in corn oil at dose rates of 25, 100, 250, and 500 mg/kg bw. Phenobarbital was used as positive control, negative control animals were treated with vehicle or remained untreated. Paralysis time was monitored following i.p. injection of zoxazolamine (75-100 mg/kg bw) and hexobarbital (150-200 mg/kg bw). Concentration of microsomal cytochrome P-450, acitivities of aminopyrine N-demethylase and aniline hydroxylase were determined in liver homogenates.
- GLP compliance:
- 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: 99.8%
- Impurities (identity and concentrations): 0.2% hexachlorobenzene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 150-260 g
- Housing: single
- Diet (e.g. ad libitum): certified Purina Rat Chow pellets
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25±2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Tetrachlorophthalic anhydride (TCPA) dosing suspensions were prepared by grinding crystalline TCPA to a fine powder in a mortar, sifting it through a fine wire screen and adding the resulting material to corn oil with continuous stirring. Animals were dosed by oral intubation with TCPA at a dose volume of 4-5 ml/kg bw.
- Duration and frequency of treatment / exposure:
- single
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 100, 250, and 500 mg/kg bw
- No. of animals per sex per dose / concentration:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- Phenobarbital
- Details on study design:
- - Dose selection rationale: Dose levels for TCPA were selected based on the results of preliminary studies. In the rat, over the 7-d dosing period, mortality was observed at 5000 mg/kg bw (5 out of 8 animals died) and at 1500 mg/kg bw (3 out of 8 animals died). Therefore, 500 mg/kg bw was the highest dose level used in the rat. At both 500 and 250 mg/kg bw in the rat, weight gain was significantly lower in the treated groups when compared with the control. No difference in weight gain between treated and control rats was observed at 100 and 25 mg/kg bw.
- Statistics:
- Phenobarbital treatment groups were compared with the control by Student’s t-test, and multiple TCPA treatment groups were compared with the control by Dunnett's test.
Results and discussion
Any other information on results incl. tables
Following treatment, a dose-dependent reduction in the zoxazolamine paralysis time occurred over the dose range 100-500 mg/kg bw. At 100, 250 and 500 mg/kg bw of TCPA, the extent of paralysis was 75%, 66% and 44% of control, respectively. No significant difference in paralysis time between the control and treated groups was found at a TCPA dose level of 25 mg/kg bw for two experimental runs. No effect on the hexobarbital sleep time was observed at any test level.
Phenobarbital caused a significant increase in the microsomal protein levels and the liver to body weight ratio, while TCPA at dose levels of 25-500 mg/kg-d produced no change in these parameters.
TCPA was found to produce statistically significant increases in hepatic aminopyrine N-demethylase, aniline hydroxylase, and cytochrome P-450 in the rat at 500 mg/kg bw (Table 1). In addition statistically significant increases were seen in aniline hydroxylase and cytochrome P-450 at 25 mg/kg bw but not at 250 mg/kg bw.
Table 1. Effects of Phenobarbital and TCPA on the Activities of Liver Microsomal Enzymesa
Test substance |
Dose level (mg/kg bw)b |
Cytochrome P-450c |
Aminopyrine N-demethylased |
Aniline hydroxylasee |
Control |
- |
1.26 ± 0.09 |
1.94 ± 0.38 |
0.86 ± 0.15 |
Phenobarbital |
80 |
2.22 ± 0.61f |
5.18 ± 0.85f |
1.50 ± 0.19f |
Control |
- |
1.35 ± 0.11 |
2.04 ± 0.60 |
0.86 ± 0.09 |
TCPA |
25 |
1.47 ± 0.21 |
2.05 ± 0.37 |
1.13 ± 0.10 |
TCPA |
250 |
1.60 ± 0.22 |
2.32 ± 0.47 |
1.05 ± 0.20 |
Control |
- |
1.30 ± 0.06 |
3.77 ± 0.47 |
1.08 ± 0.12 |
TCPA |
25 |
1.59 ± 0.16h |
3.54 ± 0.40 |
1.42 ± 0.25h |
TCPA |
500 |
1.70 ± 0.24g |
5.09 ± 1.14h |
1.54 ± 0.23g |
aValues expressed as mean ±SD.
bPhenobarbital was dosed ip for 4 d; TCPA was dosed orally for 7 d.
cIn nmol P-450/mg microsomal protein.
dIn nmol formaldehyde/min/mg microsomal protein.
eIn nmol p-aminophenol/min/mg microsomal protein.
fSignificantly different from the control, p < 0.01, by Student's t-test.
gSignificantly different from the control' p < 0.01, by Dunnett's test.
hSignificantly different from the control, p < 0.05, by Dunnett's test.
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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