Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 923-927-0 | CAS number: -
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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Titanium 2-hydroxy-1,2,3-propanetricarboxylate (2:5)
- EC Number:
- 923-927-0
- Molecular formula:
- C30H32O35.Ti2
- IUPAC Name:
- Titanium 2-hydroxy-1,2,3-propanetricarboxylate (2:5)
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- (1) Product name : CTL Ti638 UP
(2) CAS No. : Not available
(3) Lot No. : 110200/51
(4) Appearance : Orange, particulate free liquid
(5) Purity : 54.7 wt.% (Ti content 4.97 wt.%)
(6) Solubility : Water soluble
(7) Stability : Not available
(8) Storage condition : Room temperature
(9) Supplier : Catalytic Technologies Limited
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:
- S9
- Test concentrations with justification for top dose:
- Preliminary range-finding test was carried out on 0.06, 0.19, 0.56, 1.67, 5 µl/plate (three-fold serial dilutions). As a result of preliminary range-finding test, cytotoxicity was not observed at any dose levels in the presence and absence of metabolic activation system. Based on the results of preliminary range-finding test, the main test was performed on dose levels of :
- In the absence of metabolic activation system (S9 mix(-)) 0, 0.06, 0.19, 0.56, 1.67, 5 µl/plate
- In the presence of metabolic activation system (S9 mix(+)) 0, 0.06, 0.19, 0.56, 1.67, 5 µl/plate
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (CAS No.3688-53-7) and 2-Aminoanthracene (CAS No.613-13-8)
- Details on test system and experimental conditions:
- Composition
Bacterial suspension 0.1 µl
Test substance 0.05 µl
0.1M Phosphate buffered saline (direct method) 0.5 µl
S9 mix (metabolic activation method) 0.5 µl
Top agar 2.0 µl
Preincubation
Temperature 37 °C
Time 20 min
Incubation
Temperature 37 °C
Time 48 hours
No of replicants: 3 plates per dose - Evaluation criteria:
- Method of observation, measurement and analysis
(1) Colony counting
The number of revertants were counted only inside area of plate (diameter : 90 mm) by manual measurement using electronic register (Model 570, SUNTEX, Taiwan, MAI-035-01).
(2) Test method of growth inhibition
It was tested that all plate was observed with the naked eye.
(3) Measurement of bacterial concentration
It was performed by step-dilution method according to the Standard Operation Procedure, KCL.
(4) Sterility test
0.1 ml of S9 mix and test substance were mixed with top agar respectively, and then, it was added onto minimum glucose agar plate. The plate was incubated at 37 °C for 48 hours.
4) Evaluation and interpretation of results
The result was judged as ‘Positive’, if there is a concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system. - Statistics:
- The statistical method for analysis of result was not applied in this study.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- 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:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Test results (Main study)
Metabolic activation |
Dose (µl /plate) |
Number of colony/plate |
||||
Base pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
S9 Mix(-) |
0 |
100 111 102 |
10 5 5 |
21 23 25 |
8 7 8 |
4 6 6 |
Mean±SD |
104±5.9 |
7±2.9 |
23±2.0 |
8±0.6 |
5±1.2 |
|
0.06 |
95 101 100 |
6 5 8 |
26 26 26 |
10 5 12 |
6 7 5 |
|
Mean±SD |
99±3.2 |
6±1.5 |
26±0.0 |
9±3.6 |
6±1.0 |
|
0.19 |
115 105 115 |
8 7 7 |
27 19 22 |
8 11 7 |
4 6 3 |
|
Mean±SD |
111±5.5 |
7±0.6 |
23±4.0 |
9±2.1 |
4±1.5 |
|
0.56 |
111 106 117 |
5 8 6 |
26 30 23 |
13 17 9 |
5 5 6 |
|
Mean±SD |
113±8.2 |
6±1.5 |
26±3.5 |
13±4.0 |
5±0.6 |
|
1.67 |
102 116 117 |
5 7 7 |
27 28 33 |
10 8 8 |
5 5 3 |
|
Mean±SD |
112±8.4 |
6±1.2 |
29±3.2 |
9±1.2 |
4±1.2 |
|
5 |
73 68 67 |
4 6 8 |
22 22 26 |
5 5 11 |
6 5 6 |
|
Mean±SD |
69±3.2 |
6±2.0 |
23±2.3 |
7±3.5 |
6±0.6 |
|
S9 Mix(+) |
0 |
109 97 116 |
9 10 6 |
22 21 28 |
19 19 19 |
8 7 14 |
Mean±SD |
107±9.6 |
8±2.1 |
24±3.8 |
19±0.0 |
10±3.8 |
|
0.06 |
118 107 106 |
8 9 4 |
21 25 27 |
17 17 15 |
8 9 9 |
|
Mean±SD |
110±6.7 |
7±2.6 |
24±3.1 |
16±1.2 |
9±0.6 |
|
0.19 |
105 110 101 |
6 7 6 |
26 25 32 |
16 12 15 |
8 6 9 |
|
Mean±SD |
105±4.5 |
6±0.6 |
28±3.8 |
14±2.1 |
8±1.5 |
|
0.56 |
116 95 96 |
8 8 11 |
23 23 18 |
16 18 16 |
10 9 9 |
|
Mean±SD |
102±11.8 |
9±1.7 |
21±2.9 |
17±1.2 |
9±0.6 |
|
1.67 |
104 104 92 |
8 6 5 |
33 22 27 |
13 22 17 |
7 8 12 |
|
Mean±SD |
100±6.9 |
6±1.5 |
27±5.5 |
17±4.5 |
9±2.6 |
|
5 |
96 125 94 |
6 12 9 |
22 32 24 |
19 21 19 |
10 7 9 |
|
Mean±SD |
105±17.3 |
9±3.0 |
26±5.3 |
20±1.2 |
9±1.5 |
|
S9 Mix (-) |
Positive controls |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
9-AA |
Dose (㎍/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Number of Colony |
516 534 493 |
218 230 206 |
210 255 256 |
395 404 448 |
2682 3005 2933 |
|
Mean±SD |
514±20.6 |
218±12.0 |
240±26.3 |
416±28.4 |
2873±169.6 |
|
S9 Mix (+) |
Positive controls |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Dose (㎍/plate) |
1.0 |
2.0 |
10 |
0.5 |
2.0 |
|
Number of colony |
666 634 631 |
183 182 191 |
296 271 276 |
192 214 219 |
142 175 148 |
|
Mean±SD |
644±19.4 |
185±4.9 |
281±13.2 |
208±14.4 |
155±17.6 |
|
Applicant's summary and conclusion
- Conclusions:
- Four histidine-requring strains of Samonella typhimurium (TA100, TA1535, TA98 and TA1537) and one tryptophan-requring strain of Escherichia coli (WP2uvrA) were used to evaluate the mutagenic potential of the test substance CTL Ti638 UP in the presence and absence of metabolic activation system (S9 mix). Under the conditions of this test, the results were as follows:
TA100, TA1535, WP2uvrA, TA98 and TA1537 :
Regardless of metabolic activation system, the number of revertant colony did not show increase compared with the number of revertant colony of negative control group - Executive summary:
To evaluate the mutagenic potential of CTL Ti638 UP in bacteria, a bacterial reverse mutation study was performed with preincubation method using four histidine-requiring strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and one tryptophan-requiring strain of Escherichia coli (WP2uvrA) in the presence and absence of metabolic activation system (S9 mix). The test substance was dissolved in distilled water and then it was applied to the test strains at the following dose levels:
In the absence of metabolic activation system (S9 mix(-)) 0, 0.06, 0.19, 0.56, 1.67, 5 µl/plate
In the presence of metabolic activation system (S9 mix(+)) 0, 0.06, 0.19, 0.56, 1.67, 5 µl/plate
No increase in the number of revertant colonies was seen in TA98, TA100, TA1535, TA1537 and WP2uvrA strain compared with negative control groups in the presence and absence of the metabolic activation system.
Considering these findings, it is concluded that the test substance CTL Ti638 UP does not induce reverse mutation in the 5 bacterial strains which were used in this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
