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EC number: 641-088-6 | CAS number: 1229648-98-9
- 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:
- 2002-10-01 to 2002-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]
- EC Number:
- 296-557-4
- EC Name:
- Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]
- Cas Number:
- 92797-22-3
- IUPAC Name:
- 92797-22-3
- Reference substance name:
- Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- IUPAC Name:
- Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- Details on test material:
- - Name of test material (as cited in study report): POLYRAM L200
- Chemical name : Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- CAS number : 92797-22-3
- Physical state: clear brown liquid
- Analytical purity: > 95% expressed in amines content
- Purity test date: 2002-06-20
- Lot/batch No.: 94052206
- Expiration date of the lot/batch: July 2003.
- Storage condition of test material: in dark and at room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- TA1535 and TA100: his G 46
TA1537: his C 3076
TA98: his D 3052
TA102: his G 428
Species / strain
- Species / strain / cell type:
- other: S.typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (liver post mitochondrial fraction of rats induced with Aroclor 1254)
- Test concentrations with justification for top dose:
- first assay without activation: 0, 0.5, 1.5, 5, 15, 50, 100 μg/plate
first assay with activation: 0, 1.5, 5, 15, 50, 150, 300 μg/plate
second assay with and without activation 0, 1.5, 5, 15, 50, 100 μg/plate, for all strains except for TA102 without activation: 0, 0.5, 1.5, 5, 15, 50 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: compatible with the test system
- Lot: DMSO for chromatography MERCK, batch # k30049278211
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: different for the respective strains, see below under "Positive test substances"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation): first mutagenicity test and second mutagenicity test without S9 mix
- Preincubation (60 minutes at 37°C ) only in second mutagenicity test with S9 mix
- Exposure duration: 48h
SELECTION AGENT (mutation assays): agar containing traces of histidine and biotin, maintained at 45°C
NUMBER OF REPLICATIONS: two independent mutagenicity experiments each using three plates/dose-level
DETERMINATION OF CYTOTOXICITY
- Method: the evaluation of the toxicity was based on the decrease in the number of revertant colonies and/or thinning of the bacterial lawn. - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result.
Reference to historical data or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained. - Statistics:
- In parallel to criteria based on biological significance, data were analysed by means of Dunnett's method (Mahon G.A.T. et al, 1989) allowing the comparison of the mean value for each dose with the mean value for the corresponding solvent control.
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:
- cytotoxicity
- Remarks:
- at 50 - 300 µg/plate, with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 50 - 300 µg/plate, with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- other: yes, even though in assay 1 the positive reference compound induced a statistically and biologically significant increase in the number of revertants compared to the control with a ratio of only 2.8.
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: occurred at 150 µg/plate and higer concentrations
RANGE-FINDING/SCREENING STUDIES:
doses of 0, 50, 150, 500, 1500, 5000 µg/plate were tested, bacterial growth was completely inhibited at 150 - 500 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA:
yes, historical data available in the study report - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Toxicity assay
Strain |
Dose µg/plate |
without S9-mix |
with S9-mix |
||||
T |
P |
Revertants/ plate |
T |
P |
Revertants/ plate |
||
TA 1535 |
0 |
- |
- |
10 |
- |
- |
12 |
50 |
N |
- |
0 |
- |
- |
6 |
|
150 |
N |
+ |
0 |
+ |
+ |
8 |
|
500 |
N |
++ |
0 |
N |
++ |
0 |
|
1500 |
N |
++ |
0 |
N |
++ |
0 |
|
5000 |
N |
++ |
0 |
N |
++ |
0 |
|
|
|||||||
TA 1537 |
0 |
- |
- |
3 |
- |
- |
6 |
50 |
N |
- |
0 |
- |
- |
7 |
|
150 |
N |
+ |
0 |
+ |
+ |
3 |
|
500 |
N |
++ |
0 |
N |
++ |
0 |
|
1500 |
N |
++ |
0 |
N |
++ |
0 |
|
5000 |
N |
++ |
0 |
N |
++ |
0 |
|
|
|||||||
TA 98 |
0 |
- |
- |
11 |
- |
- |
9 |
50 |
N |
- |
0 |
- |
- |
13 |
|
150 |
N |
+ |
0 |
+ |
+ |
13 |
|
500 |
N |
++ |
0 |
N |
++ |
0 |
|
1500 |
N |
++ |
0 |
N |
++ |
0 |
|
5000 |
N |
++ |
0 |
N |
++ |
0 |
|
|
|||||||
TA 100 |
0 |
- |
- |
106 |
- |
- |
111 |
50 |
N |
- |
0 |
- |
- |
99 |
|
150 |
N |
+ |
0 |
+ |
+ |
53 |
|
500 |
N |
++ |
0 |
N |
++ |
0 |
|
1500 |
N |
++ |
0 |
N |
++ |
0 |
|
5000 |
N |
++ |
0 |
N |
++ |
0 |
|
|
|||||||
TA 102 |
0 |
- |
- |
184 |
- |
- |
243 |
50 |
N |
- |
0 |
- |
- |
277 |
|
150 |
N |
+ |
0 |
+ |
+ |
270 |
|
500 |
N |
++ |
0 |
N |
++ |
0 |
|
1500 |
N |
++ |
0 |
N |
++ |
0 |
|
5000 |
N |
++ |
0 |
N |
++ |
0 |
T=Toxicity
(- non toxic; + slightly toxic; ++ moderately toxic; +++ strongly toxic; N no bacterial growth)
P = Precipitate
(- absence; + slight precipitate; ++ moderate precipitate; +++ important precipitate hindering scoring)
Table 2: MUTAGENICITY ACTIVITY ASSAY, RECAPITULATION : ASSAY 1
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA102 |
|||||
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
|
Postive control |
(a) |
524.7 |
(a) |
349.0 |
(a) |
707.0 |
(a) |
1411.7 |
(a) |
1256.0 |
TEST COMPOUND without S9-mix |
0 |
11.8 |
0 |
3.2 |
0 |
17.7 |
0 |
68.0 |
0 |
208.3 |
0.5 |
14.0 |
0.5 |
4.0 |
0.5 |
19.0 |
0.5 |
83.7 |
0.5 |
194.7 |
|
1.5 |
13.7 |
1.5 |
6.0 |
1.5 |
19.7 |
1.5 |
98.3 |
1.5 |
196.3 |
|
5 |
18.0 |
5 |
6.0 |
5 |
15.7 |
5 |
79.7 |
5 |
192.7 |
|
15 |
13.0 |
15 |
7.3 |
15 |
18.3 |
15 |
76.3 |
15 |
191.3 |
|
50 |
11.7 |
50 |
4.3 |
50 |
12.0 |
50 |
55.7 |
50 |
67.3 |
|
100 |
0.0 |
100 |
0.0 |
100 |
0.0 |
100 |
0.0 |
100 |
0.0 |
|
|
||||||||||
Postive control |
(b) |
474.0 |
(b) |
216.7 |
(b) |
1932.0 |
(b) |
2232.7 |
(b) |
677.3 |
TEST COMPOUND with S9-mix without pre-incubation |
0 |
6.2 |
0 |
4.0 |
0 |
11.7 |
0 |
81.2 |
0 |
252.5 |
1.5 |
7.7 |
1.5 |
4.0 |
1.5 |
9.7 |
1.5 |
105.7 |
1.5 |
252.3 |
|
5 |
3.7 |
5 |
5.7 |
5 |
19.0 |
5 |
100.3 |
5 |
282.3 |
|
15 |
6.3 |
15 |
3.7 |
15 |
19.0 |
15 |
100.0 |
15 |
270.7 |
|
50 |
8.7 |
50 |
3.0 |
50 |
12.3 |
50 |
112.3 |
50 |
269.0 |
|
150 |
5.0 |
150 |
4.7 |
150 |
8.0 |
150 |
110.0 |
150 |
196.0 |
|
300 |
0.0 |
300 |
0.0 |
300 |
0.0 |
300 |
0.0 |
300 |
0.0 |
Reference positive compounds (µg/plate) :
TA1535 and TA100 : Sodium azide 1 ; TA1537 : 9-amino-acridine 50 ; TA98 : 2-nitrofluorene 2 TA102: Mitomycin C 0.125
TA1535, TA1537, TA98, TA100 : 2-anthramine 2 ; TA102: benzo(a)pyrene 2
Table 3: MUTAGENICITY ACTIVITY ASSAY, RECAPITULATION : ASSAY 2
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA102 |
|||||
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
DOSE µg/plate |
Revertants /plate |
|
Positive control |
(a) |
762.0 |
(a) |
386.3 |
(a) |
408.0 |
(a) |
476.7 |
(a) |
891.3 |
|
0 |
10.7 |
0 |
3.3 |
0 |
11.0 |
0 |
102.5 |
0 |
187.3 |
TEST COMPOUND |
1.5 |
9.0 |
1.5 |
2.3 |
1.5 |
13.0 |
1.5 |
104.0 |
0.5 |
195.7 |
|
5 |
13.3 |
5 |
5.0 |
5 |
15.3 |
5 |
101.7 |
1.5 |
187.0 |
without |
15 |
8.7 |
15 |
5.0 |
15 |
8.7 |
15 |
104.7 |
5 |
165.3 |
S9-mix |
50 |
7.7 |
50 |
3.0 |
50 |
4.3 |
50 |
58.7 |
15 |
183.0 |
|
100 |
0.0 |
100 |
0.0 |
100 |
0.0 |
100 |
0.0 |
50 |
55.3 |
|
||||||||||
Positive control |
(b) |
114.3 |
(b) |
183.0 |
(b) |
1335.0 |
(b) |
1358.0 |
(b) |
716.7 |
|
0 |
7.7 |
0 |
8.8 |
0 |
12.5 |
0 |
71.5 |
0 |
233.8 |
TEST COMPOUND |
1.5 |
5.0 |
1.5 |
5.0 |
1.5 |
14.0 |
1.5 |
86.3 |
1.5 |
173.7 |
with |
5 |
4.3 |
5 |
7.0 |
5 |
13.0 |
5 |
75.0 |
5 |
200.0 |
S9-mix |
15 |
3.7 |
15 |
2.7 |
15 |
4.3 |
15 |
65.0 |
15 |
179.0 |
with |
50 |
7.0 |
50 |
8.7 |
50 |
10.7 |
50 |
92.0 |
50 |
236.0 |
pre-incubation |
150 |
5.0 |
150 |
6.3 |
150 |
7.7 |
150 |
87.3 |
150 |
198.3 |
Reference positive compounds (µg/plate) :
TA1535 and TA100 : Sodium azide 1 ; TA1537 : 9-amino-acridine 50 ; TA98 : 2-nitrofluorene 2 TA102: Mitomycin C 0.125
TA1535, TA1537, TA98, TA100 : 2-anthramine 1 ; TA102: benzo(a)pyrene 2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Based on the results of this study, the test substance did not show any mutagenic activity in the five Salmonella typhimurium strains tested with and without metabolic activation. - Executive summary:
The potential of the test substance to induce reverse mutation in bacteria was assessed using five strains of Salmonella typhimurium according to the OECD guideline 471.The study was conducted in compliance with the principles of Good Laboratory Practices.
A preliminary toxicity test was performed to define the dose-levels of the test substance to be used for the mutagenicity study. The test item was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post- mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C). After 48 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The preliminary assays without metabolic activation showed that the test substance demonstrated a potent toxicity from 5000 to 50 µg/plate in all strains tested with a total absence of bacterial growth. The immediately lower dose of 15 µg/plate induced only a slight toxicity. Under these conditions, the dose of 100 µg/plate was retained as the maximum dose tested for the first mutagenicity assay in the absence of metabolic activation in all strains TA1535.
In the preliminary assays with metabolic activation, the test substance also demonstrated a potent toxicity from 5000 µg/plate to 500 µg/plate in all strains tested with a total absence of bacterial growth. The immediately lower dose of 150 µg/plate induced only a slight toxicity in all strains tested.
Under these conditions, the dose of 300 µg/plate was retained as the maximum dose tested for the first mutagenicity assay in the presence of metabolic activation in all strains.
In the main experiment, the number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. Nevertheless,
in the first assay in the presence of S9, the number of revertants observed for the positive control of strain TA102 was slightly lower than the lowest limit for historical values. However, the positive reference compound induced a statistically and biologically significant increase in the number of revertants compared to the control with a ratio of 2.8. The study was therefore considered valid.
In the two independent assays, no significant increase in the mean number of revertants was noted in the five Salmonella typhimurium strains tested in the presence of the test substance neither with nor without metabolic activation.
During the first assay, a statistically significant increase in the number of revertants was found in strain TA100 at the intermediate dose of 1.5 µg/plate without metabolic activation, and at the two highest doses of 50 and 150 µg/plate with metabolic activation. However, the biological threshold (ratio 2) was not reached, as the calculated ratio was 1.4 in all cases. Moreover, the effect observed without metabolic activation was neither dose-related nor reproduced in the second assay. Concerning the effect noted with metabolic activation, an increase was indeed observed in the second assay (performed with the preincubation protocol) but (i) it was not statistically significant and (ii) the ratio was not higher than 1.3. Therefore, this increase could not be attributed to a mutagenic effect
Under these experimental conditions the test substance did not show any mutagenic activity in the bacterial reverse mutation test withSalmonella typhimurium.
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