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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: scientifically acceptable study with restrictions. Neither Escherichia coli strain WP2 uvrA pKM101a nor S. typhimurium strain TA102 were employed in this study for the detection of oxidising mutagens and cross-linking agents.
Data source
Referenceopen allclose all
- 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.
- Reference Type:
- publication
- Title:
- Mutagenicity testing of di(2-ethylhexyl)phthalate and related chemicals in Salmonella.
- Author:
- Zeiger E, Haworth S, Mortelmans K, Speck W
- Year:
- 1 985
- Bibliographic source:
- Environ Mutagen 7: 213-232
Materials and methods
- Principles of method if other than guideline:
- The study was conducted according to the Standard NTP protocol (Preincubation Assay) which is comparable to the method described in the publication by Mortelsman and Zeiger (Mutat Res. 20, 455, 1-2:29-60, 2000).
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
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
- Lot/batch No.: 2F03
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenates from Aroclor 1254-induced male Sprague-Dawley rats (RLI) or male Syrian hamsters (HLI)
- Test concentrations with justification for top dose:
- 0, 33.3, 100, 333.3, 1000, 3333.3, 6666.7 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide for TA1535 and TA100, 9-aminoacridine for TA1537, and 4-nitro-o-phenylenediamine for TA98
- Remarks:
- without S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
METABOLIC ACTIVATION
The test was conducted with and without metabolic activation. In this study metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat and Syrian hamster liver were used. The percentage of S9 in the S9 mixture that was then added to cultures was 10 %.
- Evaluation criteria:
- A mutagenic response was defined as a reproducible, dose-related increase in the number of histidine-independent colonies over the spontaneous incidence; there was no requirement for a specific magnitude of increase.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 3333.3 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The final dose level selection was based on the results of a preliminary range-finding study conducted with TA 100 in the presence and absence of S-9.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mean Reverants ± SEM in different strains
Strain: TA1535
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
25 |
3.1 |
15 |
1.5 |
15 |
1.9 |
7 |
0.9 |
9 |
0.3 |
8 |
1.5 |
33.3 |
14 |
1.2 |
|
|
16 |
2.3 |
|
|
9 |
2.5 |
|
|
100 |
17 |
1 |
17 |
1.2 |
11 |
2 |
12 |
3.3 |
9 |
1.7 |
7 |
1.3 |
333.3 |
20 |
0.7 |
20 |
4.3 |
11 |
1.5 |
6 |
1.2 |
11 |
2.7 |
9 |
0 |
1000 |
18 |
3.5 |
16 |
2.6 |
8 |
1.5 |
10 |
1.8 |
13 |
4.2 |
11 |
2.4 |
3333.3 |
13p |
5.5 |
12s |
1.7 |
9 |
2.9 |
9 |
1.5 |
8p |
2.2 |
9 |
0.9 |
6666.7 |
|
|
t |
|
|
|
7 |
1.5 |
|
|
6 |
3.5 |
Positive Control |
444 |
17 |
338 |
21.3 |
458 |
3.3 |
340 |
27.4 |
374 |
12.8 |
321 |
21.4 |
Strain: TA 100
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
102 |
5.3 |
100 |
2.5 |
108 |
9.7 |
93 |
2.3 |
111 |
8.1 |
100 |
5.9 |
33.3 |
90 |
4.5 |
|
|
90 |
5.8 |
|
|
123 |
8.4 |
|
|
100 |
96 |
4 |
103 |
2.9 |
94 |
15.6 |
66 |
5.1 |
104 |
5.1 |
87 |
5.5 |
333.3 |
95 |
5.3 |
96 |
10.2 |
92 |
4.9 |
59 |
3.5 |
99 |
10.9 |
92 |
9.5 |
1000 |
82 |
5.5 |
75 |
8 |
75 |
3.6 |
59 |
4.5 |
110 |
8.2 |
99 |
0.9 |
3333.3 |
88p |
1.2 |
56s |
8.4 |
64 |
11.8 |
52 |
6.9 |
102p |
1 |
75 |
0.7 |
6666.7 |
|
|
t |
|
|
|
31 |
4.2 |
|
|
38s |
3.7 |
Positive Control |
526 |
12 |
358 |
15.3 |
1278 |
34.7 |
1953 |
36.1 |
627 |
18.2 |
823 |
37.4 |
Strain: TA98
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
16 |
1.5 |
26 |
4 |
46 |
4.2 |
29 |
2.1 |
34 |
3.1 |
36 |
2.3 |
33.3 |
13 |
3.5 |
|
|
35 |
1.5 |
|
|
29 |
2.1 |
|
|
100 |
13 |
3.5 |
25 |
3.1 |
33 |
6 |
38 |
2.7 |
33 |
6.8 |
34c |
3.5 |
333.3 |
13 |
2.6 |
31 |
3.5 |
26 |
1.9 |
37 |
3.2 |
28 |
2.3 |
34 |
1.5 |
1000 |
18 |
1.5 |
27 |
1.3 |
26 |
0.3 |
35 |
5 |
27 |
3.5 |
37 |
2.1 |
3333.3 |
15 |
0.3 |
12 |
1.7 |
24 |
4.5 |
38 |
1.9 |
26p |
3.8 |
28 |
2.6 |
6666.7 |
|
|
15s |
3.1 |
|
|
32 |
2.9 |
|
|
26 |
4.3 |
Positive Control |
615 |
9 |
738 |
59.5 |
1397 |
41.3 |
1596 |
54.6 |
798 |
62 |
847 |
64.9 |
Strain: TA1537
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
16 |
1.5 |
7 |
1.7 |
24 |
1.7 |
16 |
1.3 |
24 |
4.3 |
16 |
0.9 |
33.3 |
9 |
0.7 |
|
|
26 |
1.3 |
|
|
24 |
4.3 |
|
|
100 |
6 |
1.9 |
8 |
0.9 |
24 |
1.8 |
12 |
2.1 |
21 |
2 |
12 |
2.4 |
333.3 |
9 |
1.5 |
8 |
0.9 |
28 |
1.2 |
12 |
1.5 |
29 |
1.8 |
12 |
2.6 |
1000 |
7 |
1.2 |
7 |
1 |
20 |
2.7 |
10 |
2.3 |
22 |
2.2 |
12 |
1.7 |
3333.3 |
6p |
0.9 |
7s |
0.9 |
14 |
1.2 |
9 |
2.4 |
27p |
2.1 |
8 |
0.3 |
6666.7 |
|
|
0s |
0 |
|
|
4 |
0.9 |
|
|
6 |
1.5 |
Positive Control |
166 |
5.6 |
59 |
6.9 |
245 |
7.5 |
221 |
28 |
238 |
45.9 |
553 |
191.4 |
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; T = Toxic
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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