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EC number: 203-253-7 | CAS number: 104-93-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the summaries from 4 Ames test, as well as in vivo the test item is not genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- in the first mutation test, data was provided for 4 bacterial strains only (due to contamination in the 5th strain).
- GLP compliance:
- not specified
- Remarks:
- test performed prior to the GLP criteria
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine operon
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA100, TA1535, TA1538, TA98 and TA1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- - First mutation test: 10, 1, 0.1, 0.01 µl/plate
- Repeat test: 0.1, 0.01, 0.001, 0.0001 µl/plate - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: TA 1535/100 sodium azide (5µg/plate); -S9: TA 1537/1538/98 4-nitro-o-phenylenediamine (500µg/plate); +S9: TA 1535/98/100 2-amino-anthracene (2 µg/plate); +S9: TA 1537 Neutral red (10 µg/plate); +S9: TA 1538 2-acetyl-aminofluorene (20 µg/plate)
- Details on test system and experimental conditions:
- DETERMINATION OF CYTOTOXICITY
- Method: other: Bacteriostatic test assessing zone of inhibition; assessment of bacterial lawn - Key result
- Species / strain:
- other: Salmonella typhimurium strains TA100, TA1535, TA1538, TA98 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >= 1 µl /plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Under the experimental conditions of the test, there was no evidence of mutagenic potential of p-methylanisol.
Reference
Table 1: Maximum revertants/plate and corresponding test concentrations in the1st mutation test: |
|||
Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
vehicle control |
16 |
15 |
Test substance |
15 [0.1] |
14 [0.1] |
|
Positive Control |
721 |
408 |
|
S. typhimurium TA1537 |
vehicle control |
7 |
7 |
Test substance |
7 [0.01] |
7 [0.1] |
|
Positive Control |
115 |
141 |
|
S. typhimurium TA1538 |
vehicle control |
15 |
15 |
Test substance |
16 [0.1] |
15 [0.01] |
|
Positive Control |
529 |
448 |
|
S. typhimurium TA98 |
vehicle control |
34 |
36 |
Test substance |
36 [0.1] |
36 [0.1] |
|
Positive Control |
1111 |
617 |
|
S. typhimurium TA100 |
vehicle control |
contamination |
contamination |
Test substance |
contamination |
contamination |
|
Positive Control |
contamination |
contamination |
|
Table 2: Maximum revertants/plate and corresponding test concentrations in therepeat test: |
|||
Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
vehicle control |
16 |
12 |
Test substance |
18 [0.0001] |
14 [0.0001] |
|
Positive Control |
926 |
178 |
|
S. typhimurium TA1537 |
vehicle control |
8 |
10 |
Test substance |
10 [0.0001] |
10 [0.001] |
|
Positive Control |
136 |
65 |
|
S. typhimurium TA1538 |
vehicle control |
15 |
13 |
Test substance |
13 [0.0001] |
19 [0.0001] |
|
Positive Control |
1158 |
183 |
|
S. typhimurium TA98 |
vehicle control |
39 |
31 |
Test substance |
42 [0.001] |
32 [0.0001] |
|
Positive Control |
1600 |
contaminated |
|
S. typhimurium TA100 |
vehicle control |
86 |
68 |
Test substance |
92 [0.0001] |
71 [0.0001] |
|
Positive Control |
644 |
contaminated |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Based on the 2 in vivo studies, one UDS and one micronucleus, the test item is not genotoxic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In the key study similar to OECD TG 471, different ranges of 4-methylanisol concentrations (i.e. 0.01, 0.1, 1 and 10 µl/plate or 0.0001, 0.001, 0.01, 0.1 µl/plate in DMSO) were tested in an Ames test and no mutagenic potential in the Salmonella strains TA1535, TA1537, TA1538, TA98 and TA100 with/without metabolic activation was shown (Givaudan ULR/59/791049). Toxicity to bacteria was found as absence or incomplete formation of the background bacterial lawn from 1 µl/plate onward.
In a supportive study, 4-methylanisol was found negative in an Ames test at concentrations of 0.1, 0.5, 1, 2.5, 5, 10, 25 and 50 µl/plate using Salmonella strain TA1535, TA1537, TA1538, TA98 and TA100 with/without metabolic activation (Lorillard1984).
In a supportive study, 4-methylanisol was reported to be negative in an Ames test using Salmonella typhimurium strain TA 1535, TA 1537, TA 98 and TA 100 with/without metabolic activation, at a single test substance concentration, i.e. 366.5 µg/plate (Florin1980).
In vitro gene mutation of 4-methylanisol in bacteria was tested in a further Ames test specified as plate incorporation assay, being reported as short database summary. 4 -methylanisol was found negative, using Salmonella strain TA1535, TA1537, TA1538, TA98 and TA100 with/without metabolic activation (Heck1989A). The test substance concentration of 50000 µg/plate was reported as highest concentration tested.
Taken together, 4-methylanisol is not mutagenic in bacteria with or without metabolic activiation.
Justification for classification or non-classification
The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and therefore, a non-classification is warranted.
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