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EC number: 232-615-7 | CAS number: 9001-57-4
- 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:
- 08 - 20 August 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted: 21 July 1997
- Deviations:
- no
- Remarks:
- Evaluation criteria different from guideline: positive result 3 concentrations increased number of revertants
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministry of Health Welfare and Sports, Inspectorate for Health Protection, Commodities and Veterinary Public Health, GLP Compliance Monitoring unit, The Netherlands
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Xylanase, endo-1,4-
- EC Number:
- 232-800-2
- EC Name:
- Xylanase, endo-1,4-
- Cas Number:
- 9025-57-4
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- endo-1,4-beta-xylanase
1
Method
- Target gene:
- his operon (for S. typhimurium) and trp operon (for E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from livers of male Wistar rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Dose-rang finding experiment: 500, 2000, 4000, 8000, 16000 and 32000 μg dry matter/mL (TA 100 strain)
First experiment: 50, 158, 500, 1580 and 5000 μg dry matter/plate (tested up to maximum concentration)
Second experiment: 100, 266, 707, 1880 and 5000 μg dry matter/plate (tested up to maximum concentration, cooncentrations were adapted, since first experiment was negative) - Vehicle / solvent:
- - Vehicle used: sterile water
- - Justification for choice of vehicle: The test item is miscible with Glass Distilled Water (GOW) at the tested concentration of 50 mg dry matter/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 4-nitroguinoline-1-oxide; 2-Aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 67 h at 37.0 - 37.2°C (first experiment) and 36.9 -37.0 °C
NUMBER OF REPLICATIONS: triplicates in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn - Rationale for test conditions:
- Based on dose-range finding study and test for effect of protease activity on S-9 mix.
Toxicity and precipitation was tested at the following concentrations: 1000, 2000, 3000, 4000 and 5000 µg dry matter/plate. There was no precipitation, reduction of background lawn as measure of toxicity or an increase in mean number of revertant colonies oberved up to the highest dose tested (5000 µg dry matter/plate) in strain TA 100. Furthermore, the test substance at concentrations of 1000 µg dry matter/mL and 10000 µg dry matter/mL, did not inhibit the activity of S-9 mix. - Evaluation criteria:
- For tester strains TA 98, TA 100 and WP2uvrA pKM 101 the test is considered positive when the number of revertants in the treatment groups is twice that of the solvent control and this should be evident at a minimum of three dose levels.
For tester strains TA 1535 and TA 1537 the number of revertants should be thrice that of the solvent control and this should be evident at a minimum of three dose levels. - Statistics:
- Means and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In the dose-range findig test no precipitates or toxicity was observed. Furthermore, the testsfor protease acitivity revealed that the test substance did not inhibit metabolic activation.
In none of the tester strains an oncrease revertant counts were increased 2 or 3 fold
HISTORICAL CONTROL DATA (please refer to Table 5 in the 'Any other information on results incl. tables section')
- Positive historical control data: data were within the range range of historical revertant counts
- Negative (vehicle) historical control data: data were within the range of historical spontaneous revertant counts
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: reduction of background lawn
- In both experiments and for all tester strains a normal background lawn comparable to solvent control plates was observed.
OTHER:
In strain TA 98, trial I (with and without metabolic activation) and trial II with metabolic activation, there was increase in the mean numbers of revertant colonies and in strains TA 100, TA 1535 and WP2 uvrA pKM 101 there was increase, in the mean numbers of revertant colonies in the highest concentration, in both the trials, both in the presence and absence of metabolic activation. But, there was no two fold increase (TA 98, TA 100 and WP2 uvrA pKM 101 ) or three fold increase (TA 1535) when compared to that of solvent control plates.
Any other information on results incl. tables
Table 1: Experiment 1 (without S-9 mix)
Compound |
S-9 Mix |
concentration |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvra pKM 101 |
Water (0.1 mL) |
- |
0 |
20 ± 1 |
105 ± 2 |
13 ± 3 |
10 ± 1 |
102 ± 5 |
Test substance |
- |
50 |
20 ± 2 |
104 ± 3 |
15 ± 2 |
11 ± 2 |
99 ± 4 |
|
- |
158 |
22 ± 3 |
106 ± 1 |
16 ± 3 |
8 ± 1 |
102 ± 5 |
|
- |
500 |
25± 3 |
107 ± 2 |
15 ± 1 |
9 ± 1 |
99 ± 2 |
|
- |
1580 |
25 ± 2 |
116 ± 3 |
17 ± 2 |
9 ± 1 |
107 ± 5 |
|
- |
5000 |
26 ± 2 |
124 ± 3 |
22 ± 2 |
11 ± 2 |
124 ± 3 |
Positive control |
- |
|
197 ± 8 a |
506 ± 19 b |
130 ± 5 b |
102 ± 2 c |
618 ± 15 d |
Values are averages of three replicates and rounded off to the nearest whole number
a) 2-nitrofluorene: 2 µg/plate; b) sodium azide: 1 µg/plate; c) 9-aminoacridine: 50 µg/plate; d) 4-nitroquinoline-1-oxide: 4 µg/plate
Table 2: Experiment 1 (with S-9 mix)
Compound |
S-9 Mix |
concentration |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvra pKM 101 |
Water (0.1 mL) |
- |
0 |
21 ± 2 |
99 ± 3 |
13 ± 2 |
9 ± 1 |
96 ± 3 |
Test substance |
- |
50 |
23 ± 2 |
102 ± 5 |
14 ± 1 |
9 ± 1 |
100 ± 3 |
|
- |
158 |
24 ± 2 |
98 ± 2 |
14 ± 1 |
10 ± 1 |
100 ± 6 |
|
- |
500 |
22± 1 |
93 ± 4 |
15 ± 2 |
9 ± 1 |
97 ± 3 |
|
- |
1580 |
26 ± 1 |
114 ± 2 |
18 ± 1 |
8 ± 1 |
94 ± 3 |
|
- |
5000 |
28 ± 3 |
121 ± 2 |
20 ± 2 |
9 ± 1 |
121 ± 2 |
Positive control |
- |
|
745 ± 46 a |
919 ± 17 a |
140 ± 1 a |
94 ± 1 a |
525 ± 19 b |
Values are averages of three replicates and rounded off to the nearest whole number
a) 2-Aminoanthracene (2-AA): 4 µg/plate; b) 30 µg/plate
Table 3: Second experiment (without S-9)
Compound |
S-9 Mix |
concentration |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvra pKM 101 |
Water (0.1 mL) |
- |
0 |
17 ± 1 |
97 ± 3 |
13 ± 3 |
11 ± 1 |
104 ± 4 |
Test substance |
- |
100 |
19 ± 4 |
96 ± 3 |
13 ± 2 |
12 ± 1 |
105 ± 3 |
|
- |
266 |
16 ± 2 |
99 ± 4 |
18 ± 1 |
12 ± 2 |
108 ± 5 |
|
- |
707 |
14± 1 |
115 ± 2 |
16 ± 1 |
13 ± 2 |
114 ± 5 |
|
- |
1880 |
15 ± 2 |
107 ± 8 |
19 ± 2 |
13 ± 2 |
124 ± 2 |
|
- |
5000 |
18 ± 5 |
110 ± 5 |
23 ± 2 |
13 ± 3 |
137 ± 2 |
Positive control |
- |
|
171 ± 4 a |
469 ± 14 b |
126 ± 7 b |
115 ± 8 c |
626 ± 15 d |
Values are averages of three replicates and rounded off to the nearest whole number
a) 2-nitrofluorene: 2 µg/plate; b) sodium azide: 1 µg/plate; c) 9-aminoacridine: 50 µg/plate; d) 4-nitroquinoline-1-oxide: 4 µg/plate
Table 4: Second experiment (with S-9)
Compound |
S-9 Mix |
concentration |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvra pKM 101 |
Water (0.1 mL) |
- |
0 |
17 ± 2 |
108 ± 1 |
13 ± 2 |
9 ± 4 |
117 ± 3 |
Test substance |
- |
100 |
19 ± 4 |
108 ± 5 |
13 ± 2 |
11 ± 2 |
124 ± 3 |
|
- |
266 |
16 ± 2 |
116 ± 2 |
16 ± 1 |
11 ± 0 |
129 ± 3 |
|
- |
707 |
14± 1 |
118 ± 5 |
17 ± 1 |
9 ± 3 |
140 ± 2 |
|
- |
1880 |
15 ± 2 |
125 ± 5 |
20 ± 3 |
9 ± 2 |
152 ± 4 |
|
- |
5000 |
18 ± 5 |
145 ± 2 |
22 ± 1 |
10 ± 3 |
166 ± 3 |
Positive control |
- |
|
878 ± 13 a |
994 ± 7 a |
143 ± 2 a |
96 ± 4 a |
597 ± 13 b |
Values are averages of three replicates and rounded off to the nearest whole number
a) 2-Aminoanthracene (2-AA): 4 µg/plate; b) 30 µg/plate
Table 5: Historical control data
Compound |
S-9 Mix |
substance |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvra pKM 101 |
number of plates |
- |
vehicle control |
309 |
309 |
309 |
309 |
201 |
mean |
- |
vehicle control |
15.30097 |
109.3592 |
10.35275 |
7.572816 |
123.597 |
standard deviation |
- |
vehicle control |
4. 223854 |
23.47278 |
3.294304 |
3.200858 |
30.48051 |
Max |
- |
vehicle control |
30 |
192 |
23 |
16 |
210 |
Min |
- |
vehicle control |
4 |
50 |
3 |
2 |
83 |
|
|
|
|
|
|
|
|
number of plates |
+ |
vehicle control |
176 |
276 |
276 |
276 |
168 |
mean |
+ |
vehicle control |
18.72101 |
109.6739 |
10.65942 |
8.576087 |
122.4345 |
standard deviation |
+ |
vehicle control |
6.533137 |
22.67371 |
3.124091 |
2.910422 |
27.47795
|
Max |
+ |
vehicle control |
46 |
185 |
19 |
16 |
200 |
Min |
+ |
vehicle control |
4 |
16 |
2 |
2 |
77 |
|
|
|
|
|
|
|
|
number of plates |
- |
positive control |
309 |
309 |
309 |
309 |
165 |
mean |
- |
positive control |
190.3135 |
485.9769 |
171.6766 |
91.0297 |
638.103 |
standard deviation |
- |
positive control |
106.7323 |
139.4921 |
158.5474 |
36.19149 |
122.8032 |
Max |
- |
positive control |
853 |
1552 |
2198 |
229 |
1080 |
Min |
- |
positive control |
50 |
238 |
18 |
18 |
372 |
|
|
|
|
|
|
|
|
number of plates |
+ |
positive control |
294 |
294 |
294 |
294 |
168 |
mean |
+ |
positive control |
592.9626
|
918.7789 |
115.9116 |
36.45918 |
584.1607 |
standard deviation |
+ |
positive control |
183.8938 |
216.5313 |
50.91999 |
33.08418 |
138.4984 |
Max |
+ |
positive control |
1108 |
1433 |
496 |
200 |
1136 |
Min |
+ |
positive control |
161 |
320 |
41 |
20 |
360 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five tester strains (TA 98, TA 100, TA 1535, TA 1537 and WP2 uvrA pKM 101) tested with and without metabolic activation up to 5000 µg/plate.
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