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EC number: 253-781-7 | CAS number: 38103-06-9
- 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
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- 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
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- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride
- EC Number:
- 253-781-7
- EC Name:
- 4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride
- Cas Number:
- 38103-06-9
- Molecular formula:
- C31H20O8
- IUPAC Name:
- 5,5'-[propane-2,2-diylbis(4,1-phenyleneoxy)]bis(2-benzofuran-1,3-dione)
- Details on test material:
- Bisphenol A Dianhydride (BPA-DA; CAS No. 38103-06-9); Lot No. UI0049; Purity: 98.5%; from GE Plastics
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- 6.7, 10, 33, 67, 100, 333, 667, 1000, 3333 and 5000 µg per plate (Preliminary assay)
100, 333, 1000, 3333 and 5000 µg per plate (Mutagenicity assays) - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO; CAS No. 67-68-5); from Fisher Scientific
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Remarks:
- All strains; With and without activation
- Positive controls:
- yes
- Remarks:
- With S9 activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains; 1.0 µg/plate all Salmonella strains; 10 µg/plate WP2 uvrA
- Positive controls:
- yes
- Remarks:
- Without S9 activation
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535; 1.0 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9 activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA; 1,000 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9 activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537; 75 µg/plate
- Positive controls:
- yes
- Remarks:
- Without S9 activation
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98; 1.0 µg/plate
- Details on test system and experimental conditions:
- Preliminary Toxicity Assay: The preliminary toxicity assay was used to establish the dose range over which the test article would be assayed. Vehicle control and ten dose levels of the test article were plated, one plate per dose, with overnight cultures of TA98, TA100, TA1535, TA1537 and WP2 uvrA on selective minimal agar in the presence and absence of Aroclor induced rat liver S9.
Mutagenicity Assay: The mutagenicity assay (initial and independent repeat assays), was used to evaluate the mutagenic potential of the test article. Five dose levels of test article along with vehicle control and appropriate positive controls were plated with overnight cultures of TA98, TA100, TA1535, TA1537 and WP2 uvrA in the presence and absence of Aroclor induced rat liver S9. All dose levels of test article, vehicle control and positive controls were plated in triplicate.
Plating and Scoring Procedures: On the day of its use, minimal top agar was melted and supplemented. Top agar not used with S9 or Sham mix was supplemented with 25 mL of water for each 100 mL of minimal top agar. For the preparation of media and reagents, all references to water imply sterile, deionized water produced by the Milli Q Reagent Water System. Bottom agar was Vogel Bonner minimal medium E.
Each plate was labeled with a code system that identified the test article, test phase, dose level, tester strain and activation.
One half (0.5) milliliter of S9 or Sham mix, 100 uL of tester strain and 50 uL of vehicle or test article dilution were added to 2.0 mL of molten selective top agar at 45±2 degrees C. After vortexing, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar. When plating the positive controls, the test article aliquot was replaced by a 50 µL aliquot of appropriate positive control. After the overlay had solidified, the plates were inverted and incubated for approximately 48 to 72 hours at 37±2 degrees C. Plates that were not counted immediately following the incubation period were stored at 2 8 degrees C until colony counting could be conducted.
The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope. Precipitate was evaluated by visual examination without magnification.
Revertant colonies for a given tester strain and activation condition, except for positive controls, were counted either entirely by automated colony counter or entirely by hand unless the assay was the preliminary toxicity assay or the plate exhibited toxicity. - Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2.0-times the mean vehicle control value.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA1537, TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- All validity criteria were met
Any other information on results incl. tables
Initial Mutagenicity Assay - Mean Number of Revertants Per Plate
Activation: None
Dose (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
Vehicle (DMSO) |
10 ± 1 |
137 ± 12 |
12 ± 1 |
11 ± 5 |
11 ± 3 |
100 |
9 ± 2 |
137 ± 14 |
13 ± 4 |
10 ± 2 |
10 ± 1 |
333 |
11± 4 |
133 ± 15 |
12 ± 2 |
10 ± 2 |
11 ± 1 |
1000 |
13 ± 1 |
135 ± 14 |
8 ± 1 |
12 ± 1 |
10 ± 5 |
3333 |
14 ± 5 |
125 ± 3 |
12 ± 0 |
9 ± 3 |
9 ± 2 |
5000 |
15 ± 3 |
113 ± 15 |
7 ± 2 |
9 ± 1 |
9 ± 1 |
Positive Control |
128 ± 12 |
582 ± 28 |
211 ± 27 |
68 ± 6 |
74 ± 3 |
Initial Mutagenicity Assay - Mean Number of Revertants Per Plate
Activation: S9
Dose (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
Vehicle (DMSO) |
18 ± 2 |
151 ± 17 |
11 ± 3 |
11 ± 3 |
10 ± 1 |
100 |
13 ± 2 |
129 ± 3 |
12 ± 3 |
10 ± 2 |
8 ± 1 |
333 |
13 ± 3 |
118 ± 14 |
9 ± 1 |
10 ± 1 |
11 ± 2 |
1000 |
9 ± 2 |
116 ± 17 |
10 ± 2 |
9 ± 3 |
9 ± 1 |
3333 |
13 ± 2 |
120 ± 9 |
12 ± 3 |
7 ± 2 |
9 ± 1 |
5000 |
14 ± 2 |
117 ± 5 |
10 ± 4 |
10 ± 3 |
12 ± 4 |
Positive Control |
713 ± 51 |
678 ± 42 |
185 ± 9 |
246 ± 19 |
770 ± 90 |
Confirmatory Mutagenicity Assay - Mean Number of Revertants Per Plate
Activation: None
Dose (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
Vehicle (DMSO) |
15 ± 5 |
177 ± 19 |
15 ± 4 |
14 ± 1 |
18 ± 3 |
100 |
12 ± 4 |
187 ± 6 |
13 ± 2 |
19 ± 2 |
18 ± 7 |
333 |
14 ± 2 |
202 ± 25 |
11 ± 1 |
16 ± 6 |
14 ± 4 |
1000 |
12 ± 1 |
186 ± 10 |
13 ± 3 |
12 ± 3 |
9 ± 1 |
3333 |
15 ± 2 |
180 ± 34 |
15 ± 7 |
9 ± 2 |
11 ± 5 |
5000 |
15 ± 5 |
148 ± 17 |
10 ± 3 |
15 ± 5 |
11 ± 2 |
Positive Control |
133 ± 7 |
636 ± 27 |
73 ± 9 |
83 ± 4 |
157 ± 3 |
Confirmatory Mutagenicity Assay - Mean Number of Revertants Per Plate
Activation: S9
Dose (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
Vehicle (DMSO) |
27 ± 7 |
168 ± 11 |
11 ± 1 |
11 ± 4 |
20 ± 5 |
100 |
27 ± 4 |
183 ± 15 |
9 ± 5 |
11 ± 1 |
21 ± 2 |
333 |
17 ± 5 |
181 ± 7 |
11 ± 7 |
10 ± 6 |
16 ± 3 |
1000 |
14 ± 6 |
166 ± 16 |
8 ± 3 |
11 ± 4 |
14 ± 1 |
3333 |
16 ± 6 |
164 ± 4 |
11 ± 4 |
13 ± 4 |
15 ± 3 |
5000 |
15 ± 3 |
173 ± 24 |
13 ± 3 |
10 ± 3 |
11 ± 1 |
Positive Control |
920 ± 6 |
1051 ± 25 |
235 ± 4 |
234 ± 34 |
791 ± 40 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material did not cause a positive response in either the presence or absence of Aroclor induced rat liver S9 and is therefore non-mutagenic.
- Executive summary:
The study was conducted in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A in accordance with OECD 471 under GLP conditions (BioReliance, 2002).
Bacteria were exposed to the test material at concentrations up to 5000 µg/plate in DMSO both with and without S9 metabolic activation.
Under the conditions of this study, the test material did not cause a positive response in either the presence or absence of Aroclor induced rat liver S9 and is therefore non-mutagenic.
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