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EC number: 419-740-4 | CAS number: 137658-79-8 CGL 1545
- 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:
- key study
- Study period:
- Apr - Jul 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 May 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 29 Dec 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie und Bundesangelegenheiten
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol
- EC Number:
- 419-740-4
- EC Name:
- 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol
- Cas Number:
- 137658-79-8
- Molecular formula:
- C36 H45 N3 O4
- IUPAC Name:
- 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-{3-[(2-ethylhexyl)oxy]-2-hydroxypropoxy}phenol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Z 2651-01
- Expiration date of the lot/batch: February, 1997
- Purity: > 95 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: pure of expiration date
- Solubility and stability of the test substance in the solvent/vehicle: not indicated by the sponsor
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: On the day of the experiment, the test article was dissolved in acetone. The solvent was chosen because of its solubility properties and its relative nontoxicity for the bacteria.
No precipitation ofthe test article occurred up to the highest investigated dose.
OTHER SPECIFICS:
- Aggregate State at RT: solid
- Colour: yellowish
Method
- Target gene:
- his, trp
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
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mixture from aroclor induced rats
- Test concentrations with justification for top dose:
- 33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 µg/plate
- Vehicle / solvent:
- - solvent used: acetone
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity for the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine / 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: materials were mixed in a test tube and poured onto the minimal agar plates
DURATION
- Preincubation period: 60min (Exp. II, IIA, IIB)
- Exposure duration: 48h, 37°C
SELECTION AGENT (mutation assays): ampicilin
NUMBER OF REPLICATIONS: min. 3 plates per dose and strain
NUMBER OF CELLS EVALUATED: all cells per plate were counted and compared with untreated / vehicle treated cells
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; - Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
- corresponding background growth on both negative control and test plates
- normal range of spontaneous reversion rates.
A test article is considered positive if either a dose related and reproducible increase in the number of revertants or a reproducible increase for at least one test concentration is induced.
A test article producing neither a dose related and reproducible increase in the number of revertants nor a reproducibly positive response at any one of the test points is considered non-mutagenic in this system.
A mutagenic response is described as follows:
A test article is considered mutagenic if in the strains TA 100, WP2, and its uvrA derivative the number of reversions will be at least twice as high and in the strains TA 1535, TA 1537, and TA 98 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not. - Statistics:
- Due to intemational guidelines a statistical evaluation of the results is recommended.
However, no evaluated statistical procedure can be recommended for analysis of data from the bacterial assays at this time.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Pre-experiment:
To evaluate the toxicity of the test article a pre-experiment was performed with strains TA98 and TA 100. Eight concentrations were tested for toxicity and mutation induction with three plates each. The experimental conditions in this pre-experiment were the same as described for the experiment I (plate incorporation test).
Toxicity of the test article results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.
Any other information on results incl. tables
Table 1: Summary of results, without S9 mix
Concentration µg / plate |
Revertants/plate mean from three plates |
|||||||||||
TA35 |
TA1537 |
TA98 |
TA100 |
WP2 |
WP2 UVRA |
|||||||
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
|
Negative control |
14 |
14 |
14 |
8 |
23 |
17 |
102 |
82 |
39 |
36 |
43 |
40 |
Solvent control |
23 |
10 |
10 |
7 |
23 |
20 |
106 |
86 |
39 |
41 |
39 |
37 |
Positive control * |
611 |
396 |
68 |
112 |
120 |
137 |
368 |
395 |
672 |
329 |
519 |
418 |
33.3 |
15 |
6 |
12 |
12 |
19 |
15 |
149 |
72 |
32 |
37 |
43 |
41 |
100.0 |
21 |
6 |
12 |
7 |
21 |
13 |
142 |
55 |
30 |
39 |
40 |
32 |
333.3 |
14 |
7 |
10 |
11 |
20 |
13 |
144 |
43 |
32 |
38 |
42 |
30 |
1000.0 |
16 |
7 |
11 |
7 |
19 |
13 |
145 |
65 |
25 |
31 |
32 |
28 |
2500.0 |
17 |
10 |
8 |
7 |
26 |
9 |
145 |
68 |
29 |
27 |
44 |
32 |
5000.0 |
20 |
8 |
10 |
8 |
30 |
10 |
138 |
780 |
30 |
37 |
43 |
35 |
* Sodium azide (10.0 pg/plate) strains TA 1535 and TA 100
4-nitro-o-phenylene-diamine (10.0 pg/plate) strains TA 1537 and TA 98
Methyl methane sulfonate (5 pl/plate) strains WP2 uvrA and WP2
Table 2: Summary of results, with S9 mix
Concentration µg / plate |
Revertants/plate mean from three plates |
|||||||||||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 |
WP2 UVR |
|||||||||
I |
II |
I |
II |
IIa |
IIb |
I |
II |
I |
II |
I |
II |
I |
II |
|
Negative control |
27 |
10 |
14 |
9 |
21 |
10 |
25 |
21 |
124 |
116 |
33 |
37 |
37 |
40 |
Solvent control |
26 |
10 |
19 |
7 |
22 |
11 |
23 |
21 |
142 |
85 |
36 |
35 |
39 |
41 |
Positive control ** |
286 |
120 |
80 |
50 |
336 |
68 |
92 |
309 |
358 |
589 |
203 |
229 |
190 |
204 |
33.3 |
14 |
6 |
20 |
6 |
15 |
10 |
25 |
11 |
131 |
110 |
38 |
41 |
41 |
33 |
100.0 |
45 |
10 |
13 |
6 |
19 |
11 |
19 |
12 |
126 |
96 |
38 |
33 |
49 |
35 |
333.3 |
44 |
8 |
15 |
8 |
20 |
10 |
20 |
12 |
143 |
103 |
37 |
37 |
41 |
41 |
1000.0 |
36 |
7 |
17 |
10 |
18 |
14 |
29 |
14 |
145 |
113 |
41 |
36 |
47 |
41 |
2500.0 |
34 |
9 |
17 |
13 |
17 |
11 |
30 |
19 |
150 |
128 |
43 |
41 |
50 |
47 |
5000.0 |
33 |
18 |
18 |
30 |
25 |
12 |
30 |
33 |
154 |
152 |
44 |
55 |
47 |
60 |
** 2-aminoanthracene (2.5 pg/plate) strains TA 1535, TA 1537, TA 98, and TA 100
2-aminoanthracene (10.0 pg/plate) strains WP2 uvrA and WP2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, the test article is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of the test article to induce gene mutations according to the plate incorporation test (experiment I) and the preincubation test (experiment II, experiment IIA, and experiment IIB) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in addition the Escherichia coli strains WP2 and WP2 uvrA. The assay was performed with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test article was tested at the following concentrations: 33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 µg/plate.
The plates incubated with the test article showed normal background growth up to 5000.0 µg/plate with and without metabolic activation in all independent experiments. A slight toxic effect evidenced by a reduction in the number of revertants occurred at 2500.0 µg/plate in strain TA 98 without S9 mix in experiment II.
No substantial increases in revertant colony numbers of any of the six tested strains were observed following treatment with the test substance at any dose level, either in the presence or absence of metabolic activation (S9 mix) in experiment I and II. There was also no relevant tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
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