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EC number: 201-807-2 | CAS number: 88-18-6
- 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
- Study period:
- 1990-03-14 until 1991-04-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited number of values for assessment due to high cytotoxicity; poor documentation; strain to detect oxidising mutagens, cross-linking agents and hydrazines is missing; nevertheless considered sufficient for evaluation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-tert.-butylphenol
- IUPAC Name:
- 2-tert.-butylphenol
- Reference substance name:
- 2-tert-butylphenol
- EC Number:
- 201-807-2
- EC Name:
- 2-tert-butylphenol
- Cas Number:
- 88-18-6
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-tert-butylphenol
- Reference substance name:
- o.-tert.-butylphenol
- IUPAC Name:
- o.-tert.-butylphenol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-tert.-butylphenol
- Physical state: liquid
- Analytical purity: 99.97%
- Purity test date: 2014-05-07
- Lot/batch No.: 1419
- Expiration date of the lot/batch: 05/2015
- Stability under test conditions: stable
- Storage condition of test material: under N2 in tightly closed container at a cool, well ventilated place
- Colour: clear
Constituent 1
Constituent 2
Constituent 3
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- Plate incorporation test: 8 / 40 / 200 / 1000 / 5000 µg/plate
Pre-incubation test: 32 / 63 / 125 / 250 / 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Nitrofluorene (2.5 µg/plate) for the strains TA 98 and TA 1538; Sodium azide (2.5 µg/plate) for TA 100 and TA 1535; Aminoacredine (50 µg/plate) for TA 1537, Aminoanthracen (10 µg/plate) for TA 100
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Aminoanthracene (10 µg/plate) with strain TA 100
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation) and preincubation, performed in two independent tests
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 96 hours
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: not mentioned
OTHER EXAMINATIONS:
- Other: Determination of the frequency of induced or spontaneous reversion to histidine independence with negative controls (H2O), solvent controls (DMSO), test substance concentrations and positive controls; determination of the titers of overnight cultures
OTHER: none - Evaluation criteria:
- According to Ames a test article which causes no mutagenic effects at a concentration of 5000 µg/plate can be considered as non-mutagenic.
- Statistics:
- No statistics reported.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Tables 1-4 below for concentrations with cytotoxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Tables 1-4 below for concentrations with cytotoxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Tables 1-4 below for concentrations with cytotoxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Tables 1-4 below for concentrations with cytotoxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Tables 1-4 below for concentrations with cytotoxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not measured
- Effects of osmolality: not applicable
- Evaporation from medium: not applicable
- Water solubility: not mentioned
- Precipitation: no
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: not performed
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
ADDITIONAL INFORMATION ON CYTOTOXICITY: See Tables 1-4 below for concentrations with cytotoxicity.
Any other information on results incl. tables
Table 1: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
- S9 |
+ S9 |
Cytotoxic |
- S9 |
+ S9 |
Cytotoxic |
0* |
22 ± 10 |
49 ± 4 |
no |
266 ± 23 |
165 ± 17 |
no |
4 ± 4 |
15 ± 5 |
no |
8 |
23 ± 2 |
52 ± 6 |
no |
276 ± 9 |
181 ± 8 |
no |
2 ± 1 |
10 ± 4 |
no |
40 |
15 ± 4 |
46 ± 7 |
no |
224 ± 30 |
170 ± 23 |
no |
0 |
20 ± 4 |
yes |
200 |
8 ± 3 |
24 ± 1 |
no |
237 ± 6 |
143 ± 5 |
no |
0 |
14 ± 5 |
yes |
1000 |
0 |
0 |
yes |
0 |
0 |
yes |
0 |
0 |
yes |
5000 |
0 |
0 |
yes |
0 |
0 |
yes |
0 |
0 |
yes |
Positive control |
334 ± 79 |
not tested |
no |
302 ± 7 |
564 ± 167 |
no |
250 ± 18 |
not tested |
no |
*solvent control with DMSO
Table 2: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[Strain TA 1538] |
||||
Conc. |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
0* |
3 ± 3 |
18 ± 4 |
no |
47 ± 31 |
52 ± 5 |
no |
8 |
0 |
20 ± 7 |
yes |
39 ± 11 |
54 ± 10 |
no |
40 |
0 |
25 ± 10 |
yes |
32 ± 2 |
48 ± 14 |
no |
200 |
0 |
7 ± 4 |
yes |
30 ± 9 |
54 ± 12 |
no |
1000 |
0 |
0 |
yes |
0 |
0 |
yes |
5000 |
0 |
0 |
yes |
0 |
0 |
yes |
Positive control |
408 ± 233 |
not tested |
no |
177 ± 15 |
not tested |
no |
*solvent control with DMSO
Table 3: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- S9 |
+ S9 |
Cytotoxic |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
0* |
34 ± 4 |
49 ± 11 |
no |
120 ± 23 |
115 ± 16 |
no |
15 ± 4 |
19 ± 2 |
no |
32 |
40 ± 8 |
56 ± 2 |
no |
114 ± 15 |
129 ± 3 |
no |
18 ± 4 |
18 ± 4 |
no |
63 |
33 ± 4 |
54 ± 4 |
no |
130 ± 15 |
120 ± 31 |
no |
13 ± 4 |
19 ± 6 |
no |
125 |
0 |
54 ± 4 |
yes |
0 |
120 ± 14 |
yes |
0 |
14 ± 8 |
yes |
250 |
0 |
51 ± 2 |
yes |
0 |
93 ± 12 |
yes |
0 |
0 |
yes |
500 |
0 |
0 |
yes |
0 |
0 |
yes |
0 |
0 |
yes |
Positive control |
325 ± 24 |
not tested |
no |
578 ± 16 |
2531 ± 234 |
no |
487 ± 39 |
not tested |
no |
*solvent control with DMSO
Table 4: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[Strain TA 1538] |
||||
Conc. |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
- S9 |
+ S9 |
Cytotoxic (yes/no) |
0* |
12 ± 1 |
16 ± 2 |
no |
43 ± 9 |
42 ± 4 |
no |
32 |
12 ± 3 |
17 ± 6 |
no |
35 ± 5 |
47 ± 9 |
no |
63 |
9 ± 4 |
23 ± 5 |
no |
36 ± 10 |
45 ± 5 |
no |
125 |
0 |
19 ± 7 |
yes |
31 ± 4 |
61 ± 9 |
no |
250 |
0 |
3 ± 6 |
yes |
0 |
50 ± 6 |
yes |
500 |
0 |
0 |
yes |
0 |
0 |
yes |
Positive control |
633 ± 106 |
not tested |
no |
155 ± 15 |
not tested |
no |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Increase of revertant colonies was observed neither at non-cytotoxic concentrations nor at the limit concentration. Therefore, based on the results from this Ames-test the test substance can be considered as non-mutagenic. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA 1535, TA 1537 and TA 1538 ofS. typhimurium were exposed to o-tert-butylphenol in DMSO at concentrations of 8, 40, 200, 1000, and 5000 µg/plate (plate incubation assay) and 32, 63, 125, 250, 500 µg/plate (pre-incubation assay) in the presence and absence of mammalian metabolic activation.
O-tert-butylphenol was tested up to cytotoxic concentrations and the limit concentration (5000 µg/plate). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is considered to be acceptable. This study satisfies the requirements for test guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data, except that a strain to detect oxidising mutagens, cross-linking agents and hydrazines is missing (e.g. TA102 or E. coli WP2 uvrA).
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