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EC number: 607-864-3 | CAS number: 26116-57-4
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 16, 2006 to February 2, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD Guideline 471 and EU method B.13/B14, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-10-(hydroxyimino)-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one hydrochloride
- Cas Number:
- 26116-57-4
- Molecular formula:
- C37H69ClN2O13
- IUPAC Name:
- (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-10-(hydroxyimino)-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecan-2-one hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythromycin A-9 Oxime (E) Hydrochloride.
- Physical state: white powder.
- Lot/batch No.: B5310059
- Storage condition of test material: at ambient temperature, in the dark.
- Other:
pH: 6.16 (1% solution in deionised water, w/v, determined with a pH-Meter WTW pH340)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254
- Test concentrations with justification for top dose:
- Whole first experiment and second experiment with strains TA 97a, TA100 and TA1535: 0.09, 0.26, 0.8, 2.3, 7 and 21 µg/plate (with and without S9).
Second experiment with strains TA98 and TA102: 0.8, 2.3, 7, 21, 62 and 185 µg/plate (with and without S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was not enough soluble in water; DMSO is a common vehicle for the Ames test.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene, 1, 8-Dihydroxy-anthraquinone, 4-Nitro-o-phenylenediamine, t-Butyl-hydroperoxide
- Remarks:
- Without S9: 4NOPD, 2 NF, Sodium-azide, tBHPO. With S9: DMBA, 2AA,DHA.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 12h (overnight)
- Exposure duration: 2 days.
NUMBER OF REPLICATIONS: triplicate repetitions were run for each dose group in each of the two separeate experiments. Control groups: six-fold repetitions.
NUMBER OF CELLS EVALUATED: 2 to 3 x 10E9 cells/mL
DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial background. - Evaluation criteria:
- Means and standard deviations were calculated for the number of mutants in every concentration group.
The criteria for positive results are:
A reproducible increase of the number of revertants to more than the following thresholds values for at least one of the concentrations:
- For the strains with a low spontaneous revertant rate i.e. TA98 and TA 1535: the 2.5 fold of the amount of the spontaneous revertants.
- For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: the 1 2/3 fold of the amount of spontaneous revertants.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA97a, TA98, TA100, TA102 and TA1535.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Strains TA97a, TA100 and TA1535: toxic at 21µg/plate; strains TA102 and TA98: toxic at 185 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was seen in any of the concentration groups.
RANGE-FINDING/SCREENING STUDIES:
The concentrations for the first experiment were set according to a preliminary toxicity test. The test substance was toxic at 21 µg/plate and above. At 7 µg/plate and below the bacterial background lawn was normal. Therefore, 21 µg/plate was chosen as the highest concentration.
The concentrations for the second experiment were changed according to the first one only for strains TA98 and TA102. No toxicity was found in these strains at 21 µg/plate. Therefore, the concentrations were increased two steps. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mean number or revertants per plate for strain TA97a
Without metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
Toxic |
0.0 |
3 |
21 |
Toxic |
0.0 |
3 |
7 |
103.7 |
6.7 |
3 |
7 |
110.3 |
20.5 |
3 |
2.3 |
95.3 |
16.9 |
3 |
2.3 |
124.7 |
12.5 |
3 |
0.8 |
112.0 |
13.5 |
3 |
0.8 |
117.0 |
32.4 |
3 |
0.26 |
119.0 |
3.5 |
3 |
0.26 |
118.7 |
16.2 |
3 |
0.09 |
118.0 |
19.3 |
3 |
0.09 |
129.0 |
23.3 |
3 |
solvent |
103.3 |
8.4 |
6 |
solvent |
125.2 |
15.5 |
6 |
positive |
349.0 |
10.8 |
3 |
positive |
368.0 |
19.1 |
3 |
With metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
Toxic |
0.0 |
3 |
21 |
Toxic |
0.0 |
3 |
7 |
112.3 |
12.4 |
3 |
7 |
133.0 |
17.6 |
3 |
2.3 |
121.3 |
21.5 |
3 |
2.3 |
133.7 |
11.0 |
3 |
0.8 |
140.7 |
8.0 |
3 |
0.8 |
151.7 |
11.7 |
3 |
0.26 |
150.3 |
20.0 |
3 |
0.26 |
134.3 |
29.5 |
3 |
0.09 |
127.3 |
4.0 |
3 |
0.09 |
142.3 |
3.1 |
3 |
solvent |
128.0 |
14.2 |
6 |
solvent |
141.8 |
11.5 |
6 |
positive |
609.0 |
162.5 |
3 |
positive |
991.3 |
33.7 |
3 |
Table 2: Mean number of revertants per plate for strain TA98
Without metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
6.3 |
1.5 |
3 |
185 |
Toxic |
0.0 |
3 |
7 |
11.7 |
2.5 |
3 |
62 |
0.0 |
0.0 |
3 |
2.3 |
11.0 |
3.0 |
3 |
21 |
8.0 |
1.0 |
3 |
0.8 |
11.0 |
2.6 |
3 |
7 |
9.7 |
5.1 |
3 |
0.26 |
11.7 |
1.5 |
3 |
2.3 |
10.7 |
3.8 |
3 |
0.09 |
12.3 |
2.1 |
3 |
0.8 |
11.0 |
5.0 |
3 |
solvent |
10.5 |
2.6 |
6 |
solvent |
12.7 |
3.2 |
6 |
positive |
147.7 |
6.4 |
3 |
positive |
130.0 |
29.3 |
3 |
With metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
8.7 |
3.1 |
3 |
185 |
Toxic |
0.0 |
3 |
7 |
13.3 |
0.6 |
3 |
62 |
0.0 |
0.0 |
3 |
2.3 |
15.7 |
1.5 |
3 |
21 |
7.0 |
3.6 |
3 |
0.8 |
13.7 |
4.9 |
3 |
7 |
12.3 |
3.1 |
3 |
0.26 |
14.7 |
0.6 |
3 |
2.3 |
14.3 |
0.6 |
3 |
0.09 |
15.0 |
2.0 |
3 |
0.8 |
10.7 |
5.1 |
3 |
solvent |
13.2 |
2.9 |
6 |
solvent |
13.2 |
2.6 |
6 |
positive |
311.0 |
38.3 |
3 |
positive |
237.7 |
28.5 |
3 |
Table 3: Mean number of revertants per plate for strain TA100
Without metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
Toxic |
0.0 |
3 |
21 |
toxic |
0.0 |
3 |
7 |
139.3 |
10.1 |
3 |
7 |
42.7 |
5.7 |
3 |
2.3 |
177.7 |
32.9 |
3 |
2.3 |
61.3 |
4.9 |
3 |
0.8 |
151.3 |
12.9 |
3 |
0.8 |
75.0 |
11.8 |
3 |
0.26 |
165.7 |
24.6 |
3 |
0.26 |
82.3 |
15.0 |
3 |
0.09 |
185.7 |
19.4 |
3 |
0.09 |
81.7 |
13.7 |
3 |
solvent |
176.2 |
16.2 |
6 |
solvent |
78.5 |
11.0 |
6 |
positive |
416.3 |
22.7 |
3 |
positive |
487.0 |
39.7 |
3 |
With metabolic activation |
|||||||
First experiment |
Second experiment |
||||||
Conc. µg/plate
|
Revertants / plate |
Conc. µg/plate
|
Revertants / plate |
||||
mean |
SD |
N |
mean |
SD |
N |
||
21 |
Toxic |
0.0 |
3 |
21 |
Toxic |
0.0 |
3 |
7 |
182.0 |
7.8 |
3 |
7 |
60.7 |
8.5 |
3 |
2.3 |
181.7 |
10.1 |
3 |
2.3 |
77.3 |
9.2 |
3 |
0.8 |
181.0 |
8.7 |
3 |
0.8 |
84.0 |
17.8 |
3 |
0.26 |
177.0 |
12.3 |
3 |
0.26 |
90.7 |
25.0 |
3 |
0.09 |
157.7 |
14.0 |
3 |
0.09 |
109.0 |
35.3 |
3 |
solvent |
177.3 |
8.3 |
6 |
solvent |
94.0 |
15.3 |
6 |
positive |
1397.7 |
29.5 |
3 |
positive |
1396.3 |
60.7 |
3 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
According to the results obtained in this study, the test substance is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535, with and without an external metabolising system up to the limit of toxicity. - Executive summary:
The test substance was tested for mutagenic activity with the “Salmonella typhimurium Reverse Mutation Test” (Ames test). The study was conducted according to OECD Guideline 471 and B.13 EU Method, with GLP. The test substance was dissolved in DMSO. The test test was performed according to the “direct plate incorporation method”. As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. An independent repetition of the experiment was performed. According to the results obtained in this study, the test substance is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535, with and without an external metabolising system up to the limit of toxicity.
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