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EC number: 211-402-2 | CAS number: 643-79-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- - Principle of test:
The test item ortho-phthalaldehyde was incubated with Salmonella typhimurium tester strains TA98 and TA100 and an Escherichia coli strain WP2 uvrA/pKM101, either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague Dawley rat liver) for 20 minutes at 37 ºC. Top agar supplemented with L-histidine (for the S. typhimurium strains) or tryptophan (for the E. coli strain) and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine- or tryptophan-independent mutant colonies arising on these plates were counted following 2 days incubation at 37 ºC.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phthalaldehyde
- EC Number:
- 211-402-2
- EC Name:
- Phthalaldehyde
- Cas Number:
- 643-79-8
- Molecular formula:
- C8H6O2
- IUPAC Name:
- phthalaldehyde
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MP Biomedicals, LLC (Solon, OH), Lot No. 8674J
- Appearance: pale-yellow, coarse, crystalline material
- Purity: >99 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test chemical was stored refrigerated in the original sealed plastic containers.
Method
- Target gene:
- Histidine locus (S. typhimurium), tryptophan locus (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Details on mammalian cell type (if applicable):
- MEDIA USED
- Type and identity of media: Top agar supplemented with L-histidine and d-biotin poured onto surfaces of minimal glucose agar plates - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- MEDIA USED
- Type and identity of media: Top agar supplemented with tryptophan and d-biotin poured onto surfaces of minimal glucose agar plates - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- n.a.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation mix
- Test concentrations with justification for top dose:
- The highest concentration tested was limited by toxicity.
Test concentrations: (TA100): 0, 0.5, 1, 5, 10, 25, 50, 100, 200, 300 and 400 µg/plate
Test concentrations: (TA98 and E.coli WP2 uvrA/pKM101): 0, 0.5, 1, 5, 10, 25, 50, 100, 200 µg/plate - Vehicle / solvent:
- - Solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- E.coli, without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains, with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
- Cell density at seeding (if applicable): not specified
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: 3 - Rationale for test conditions:
- n.a.
- Evaluation criteria:
- In this assay, a positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response is defined as an increase in revertants that is not dose-related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity. A negative response is obtained when no increase in revertant colonies is observed following chemical treatment. There is no minimum percentage or fold-increase required for a chemical to be judged positive or weakly positive, although positive calls are typically reserved for increases in mutant colonies that are at least twofold over background.
- Statistics:
- n.a.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- For individual results see Table 1 in box "Any other information on results incl. tables"
Any other information on results incl. tables
Table 1: Mutagenicity of o-Phthalaldehyde in Bacterial Tester Strains
Strain |
Dose (µg/plate) |
Without S9 |
Without S9 |
With 10% rat S9 |
With 10% rat S9 |
TA100 |
0 |
98 ± 1 |
104 ± 4 |
116 ± 7 |
145 ± 4 |
|
0.5 |
|
100 ± 11 |
|
|
|
1 |
|
108 ± 3 |
|
|
|
5 |
124 ± 2 |
110 ± 8 |
|
|
|
10 |
147 ± 8 |
155 ± 5 |
139 ± 5 |
|
|
25 |
191 ± 15 |
224 ± 2 |
129 ± 3 |
|
|
50 |
58 ± 6 |
|
127 ± 3 |
140 ± 2 |
|
100 |
0 ± 0 |
|
152 ± 3 |
157 ± 2 |
|
200 |
|
|
162 ± 15 |
136 ± 3 |
|
300 |
|
|
|
62 ± 8 |
|
400 |
|
|
|
1 ± 1 |
Trial summary |
|
Positive |
Positive |
Negative |
Negative |
Positive control |
|
443 ± 15 |
599 ± 29 |
771 ± 34 |
680 ± 15 |
TA98 |
0 |
40 ± 4 |
37 ± 1 |
41 ± 2 |
46 ± 4 |
|
0.5 |
40 ± 4 |
|
|
|
|
1 |
47 ± 3 |
|
|
|
|
5 |
55 ± 1 |
40 ± 1 |
|
|
|
10 |
53 ± 0 |
39 ± 1 |
36 ± 3 |
62 ± 3 |
|
25 |
19 ± 3 |
31 ± 5 |
37 ± 3 |
49 ± 2 |
|
50 |
|
43 ± 4 |
32 ± 2 |
61 ± 3 |
|
100 |
|
0 ± 0 |
27 ± 1 |
55 ± 4 |
|
200 |
|
|
28 ± 2 |
25 ± 4 |
Trial summary |
|
Negative |
Negative |
Negative |
Negative |
Positive control |
|
560 ± 36 |
564 ± 11 |
1061 ± 146 |
861 ± 71 |
E.coli WP2 uvrA/pKM101 |
0 |
176 ± 15 |
228 ± 20 |
205 ± 8 |
194 ± 22 |
|
0.5 |
|
230 ± 6 |
|
|
|
1 |
|
254 ± 20 |
|
|
|
5 |
175 ± 12 |
244 ± 7 |
|
|
|
10 |
200 ± 5 |
285 ± 8 |
248 ± 8 |
194 ± 14 |
|
25 |
207 ± 4 |
77 ± 7 |
241 ± 15 |
194 ± 25 |
|
50 |
252 ± 8 |
|
245 ± 13 |
198 ± 5 |
|
100 |
81 ± 13 |
|
251 ± 8 |
224 ± 28 |
|
200 |
|
|
264 ± 14 |
223 ± 9 |
Trial summary |
|
Negative |
Negative |
Negative |
Negative |
Positive control |
|
799 ± 52 |
667 ± 29 |
641 ± 25 |
913 ± 64 |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item, ortho-phthalaldehyde was found to be mutagenic in Salmonella typhimurium strain TA100 in the absence of S9 metabolic activation system but was non-mutagenic in the presence of S9 metabolic activation. In Salmonella typhimurium strain TA98 and E.coli WP2 uvrA/pKM101, the test item was found to be non-mutagenic in the presence and absence of S9 metabolic activation system.
- Executive summary:
In a reverse gene mutation assay in bacteria conducted similar to guideline OECD 471, strains of S. typhimurium (TA98, TA100) and E.coli WP2 uvrA/pKM101 were exposed to the test item, ortho-phthalaldehyde in DMSO at concentrations of 0, 0.5, 1, 5, 10, 25, 50, 100, 200 µg/plate for TA98 and E. coli WP2 uvrA/pKM101 and at concentrationa of 0, 0.5, 1, 5, 10, 25, 50, 100, 200, 300 and 400 µg/plate for TA100. The positive controls induced the appropriate responses in the corresponding strains. Under the conditions of this study, the test item was found to be mutagenic in S. typhimurium strain TA100 in the absence of S9 metabolic activation system but non-mutagenic in the presence of S9 metabolic activation. In S. typhimurium strain TA98 and E. coli WP2 uvrA/pKM101, the test item was found to be non-mutagenic in the presence and absence of S9 metabolic activation system.
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