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EC number: 947-744-0 | CAS number: -
- 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:
- 2017-03-20 to 2017-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- In accordance with the OECD guideline for testing of chemicals No. 471 “Bacterial Reverse Mutation Test”, adopted on 21st July 1997.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Clariant / DEG4338635
- Expiration date of the batch: 2018-10-04
- Purity test date: 2016-10-04
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
- Solubility of the test substance in the vehicle: Acetone
- Reactivity of the test substance with the vehicle of the cell culture medium: Soluble
Method
- Target gene:
- Histidine & Tryptophan Locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sodium phenobarbitone and β-naphthoflavone induced rat liver S9 homogenate was used as the metabolic activation system
- Test concentrations with justification for top dose:
- In mutation assay the test item was tested at the concentrations of 0.05, 0.16, 0.50, 1.58 and 5 mg/plate. The test concentrations for mutation assay were selected based on the results of solubility, precipitation and initial cytotoxicity test.
- Vehicle / solvent:
- Vehicle used:acetone
Justification for choice of vehicle: The test item was soluble in acetone at a concentration of 50 mg/mL
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-amioantracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar -plate incorporation & preincubation; with and without metabolic activation
DURATION
Plate incorporation: 65 hrs
- Preincubation period:30 minutes
- Postincubation period: 63 hrs 45 minutes
NUMBER OF REPLICATIONS: triplicates
- OTHER: cytotoxicity by lawn evaluation & mutation assay by counting revertant colonies. - Rationale for test conditions:
- not applicable
- Evaluation criteria:
- The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value in Salmonella typhimurium strains TA98, TA100 and Escherichia coli WP2 uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value in tester strains TA1535 and TA1537.There was no appreciable increase in number of revertant colonies at any of the tested concentrations in both the trials.
- Statistics:
- not applicable
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2 uvrA (pKM101).
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: No, soluble in acetone
- Precipitation: The test item resulted in precipitation at 3, 4 and 5 mg/plate and minimal precipitation was observed at 2 mg/plate and no precipitation was observed at 1, 0.9, 0.8,0.7 mg/plate.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
Plate incorporation method
Tester Strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 401.7 383. 140.1 119.2 383.5
SD ±23.4 ±16.9 ±8.0 ±6.6 ±9.8
Min 256 246 118 100 320
Max 440 419 1 82 149 421
Tester Strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 396.6 379.7 141.1 120.1 383.1
SD ±27.4 ±18.3 ±9.9 ±7.3 ±10.4
Min 290 270 110 98 371
Max 430 446 190 158 416
Pre incubation method
Tester Strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (With S9)
Mean 402.5 383.9 140.6 118.6 382.9
SD ±18.5 ±16.1 ±9.3 ±6.3 ±10.4
Min 290 293 103 99 330
Max 429 425 187 151 412
Tester Strain TA 98 TA 100 TA 1535 TA 1537 E.COLI PKM 101 (Without S9)
Mean 3398.3 381.3 141.3 119.5 382.8
SD ±24.5 ±16.2 ±11.0 ±6.4 ±10.3
Min 281 312 110 97 321
Max 428 450 200 173 418
Any other information on results incl. tables
TABLE 1. SUMMARY OF INITIAL CYTOTOXICITY TEST-SALMONELLA TYPHIMURIUMTA100
Initial Cytotoxicity Test
Test Item Concentration (mg/plate) |
No. of Revertants/plate |
|||||||||||
With S9 |
Without S9 |
|||||||||||
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
|
Vehicle Control |
106 |
98 |
105 |
103 |
4.4 |
4+ |
103 |
93 |
110 |
102 |
8.5 |
4+ |
2 |
91 |
88 |
101 |
93 |
6.8 |
4+ |
85 |
96 |
102 |
94 |
8.6 |
4+ |
1 |
102 |
108 |
104 |
105 |
3.1 |
4+ |
93 |
101 |
104 |
99 |
5.7 |
4+ |
0.9 |
93 |
102 |
102 |
99 |
5.2 |
4+ |
105 |
98 |
91 |
98 |
7.0 |
4+ |
0.8 |
84 |
103 |
89 |
92 |
9.8 |
4 + |
107 |
101 |
94 |
101 |
6.5 |
4+ |
0.7 |
108 |
92 |
111 |
104 |
10.2 |
4+ |
107 |
109 |
90 |
102 |
10.4 |
4+ |
Follow-up Initial Cytotoxicity Test
Test Item Concentration (mg/plate) |
No. of Revertants/plate |
|||||||||||
With S9 |
Without S9 |
|||||||||||
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
|
Vehicle Control |
107 |
96 |
101 |
101 |
5.5 |
4+ |
98 |
102 |
92 |
97 |
5.0 |
4+ |
5 |
90 |
87 |
92 |
90 |
2.5 |
4+ |
85 |
94 |
91 |
90 |
4.6 |
4+ |
4 |
99 |
84 |
93 |
92 |
7.5 |
4+ |
92 |
79 |
88 |
86 |
6.7 |
4+ |
3 |
80 |
92 |
89 |
87 |
6.2 |
4+ |
88 |
100 |
93 |
94 |
6.0 |
4+ |
2.75 |
86 |
94 |
90 |
90 |
4.0 |
4+ |
78 |
101 |
90 |
90 |
11.5 |
4+ |
2.5 |
87 |
94 |
105 |
95 |
9.1 |
4+ |
81 |
98 |
94 |
91 |
8.9 |
4+ |
2.25 |
104 |
92 |
96 |
97 |
6.1 |
4+ |
102 |
95 |
89 |
95 |
6.5 |
4+ |
2 |
91 |
88 |
85 |
88 |
3.0 |
4+ |
81 |
87 |
98 |
89 |
8.6 |
4+ |
1 |
90 |
95 |
80 |
88 |
7.6 |
4+ |
96 |
84 |
81 |
87 |
7.9 |
4+ |
Values of Revertants are in Mean±SD
Lawn intensity: 4+= Thick lawns: Distinguished by a healthy (Normal) background lawn comparable tovehiclecontrol plates.
TABLE 2. SUMMARY OF COLONY COUNTS OF REVERTANTS OF TRIAL-I
Plate Incorporation Method
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||||
Vehicle Control |
100 µL of Acetone |
Mean |
25.0 |
104.0 |
19.3 |
11.0 |
175.0 |
23.3 |
99.7 |
20.3 |
9.7 |
173.7 |
|
±SD |
3.6 |
10.4 |
2.5 |
2.0 |
9.2 |
4.0 |
4.7 |
3.1 |
2.5 |
5.5 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Hostacerin DGSB |
5 |
Mean |
17.3 |
99.0 |
20.3 |
7.3 |
164.0 |
18.7 |
101.7 |
18.7 |
7.3 |
166.3 |
|
±SD |
3.1 |
14.5 |
3.8 |
2.5 |
5.6 |
2.5 |
10.5 |
2.5 |
2.1 |
5.5 |
|||
Fold Increase |
0.7 |
1.0 |
1.1 |
0.7 |
0.9 |
0.8 |
1.0 |
0.9 |
0.8 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
1.58 |
Mean |
18.0 |
94.7 |
19.0 |
6.0 |
167.3 |
18.7 |
87.7 |
18.3 |
7.0 |
173.7 |
||
±SD |
3.6 |
12.5 |
4.6 |
2.0 |
6.4 |
4.0 |
5.1 |
3.8 |
3.6 |
7.1 |
|||
Fold Increase |
0.7 |
0.9 |
1.0 |
0.5 |
1.0 |
0.8 |
0.9 |
0.9 |
0.7 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.5 |
Mean |
19.3 |
102.3 |
18.0 |
7.3 |
163.3 |
18.0 |
92.0 |
16.0 |
8.3 |
165.3 |
||
±SD |
4.2 |
7.1 |
1.7 |
4.2 |
8.0 |
4.4 |
11.0 |
2.0 |
2.9 |
6.7 |
|||
Fold Increase |
0.8 |
1.0 |
0.9 |
0.7 |
0.9 |
0.8 |
0.9 |
0.8 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.16 |
Mean |
18.0 |
91.7 |
15.7 |
8.7 |
165.3 |
18.7 |
97.7 |
16.7 |
9.0 |
170.7 |
||
±SD |
1.0 |
9.1 |
1.5 |
1.2 |
14.0 |
4.7 |
9.7 |
3.2 |
2.0 |
9.5 |
|||
Fold Increase |
0.7 |
0.9 |
0.8 |
0.8 |
0.9 |
0.8 |
1.0 |
0.8 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.05 |
Mean |
19.7 |
102.3 |
16.3 |
6.7 |
167.0 |
19.0 |
99.7 |
18.0 |
9.0 |
169.3 |
||
±SD |
2.5 |
8.6 |
3.5 |
2.5 |
11.4 |
2.6 |
5.9 |
2.0 |
3.6 |
16.0 |
|||
Fold Increase |
0.8 |
1.0 |
0.8 |
0.6 |
1.0 |
0.8 |
1.0 |
0.9 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
372.3 |
390.7 |
142.3 |
115.7 |
397.0 |
319.7 |
380.3 |
137.3 |
113.7 |
385.0 |
|
±SD |
20.4 |
19.4 |
12.3 |
8.5 |
15.1 |
22.1 |
22.5 |
7.0 |
5.7 |
28.4 |
|||
Fold Increase |
14.9 |
3.8 |
7.4 |
10.5 |
2.3 |
13.7 |
3.8 |
6.8 |
11.8 |
2.2 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
Values of Revertants are in Mean±SD
Positive controls:
For with S9:
ForSalmonella typhimuriumTA98, TA100, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene
ForEscherichia coliWP2 uvrA (pKM101)strain +S9 = 30µg/plate of 2-Aminoanthracene
For without S9:
For TA98: 2 µg/plate of 2-Nitrofluorene
For TA100 and TA1535: 1 µg/plate of Sodium azide.
For TA1537: 50 µg/plate of 9-Aminoacridine
ForEscherichia coliWP2 uvrA (pKM101): 5 µg/plate of4-Nitroquinoline N-oxide
TABLE 3. SUMMARY OF COLONY COUNTS OF REVERTANTS OF TRIAL-II
Preincubation Method
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
Salmonella typhimurium |
E.coliWP2 uvrA (pKM 101) |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||||
Vehicle Control |
100 µL of Acetone |
Mean |
25.3 |
106.3 |
22.3 |
10.7 |
177.7 |
24.0 |
102.0 |
21.3 |
12.0 |
178.7 |
|
±SD |
3.1 |
12.1 |
4.2 |
1.2 |
7.8 |
3.6 |
4.0 |
4.0 |
2.0 |
3.5 |
|||
Lawn Intensity |
4+ |
4+ |
23 |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Hostacerin DGSB |
5 |
Mean |
20.7 |
106.7 |
18.7 |
9.3 |
175.0 |
20.7 |
100.7 |
20.7 |
7.0 |
168.0 |
|
±SD |
4.2 |
6.8 |
6.1 |
2.5 |
9.2 |
4.7 |
4.5 |
2.1 |
3.0 |
10.5 |
|||
Fold Increase |
0.8 |
1.0 |
0.8 |
0.9 |
1.0 |
0.9 |
1.0 |
1.0 |
0.6 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
1.58 |
Mean |
20.3 |
102.7 |
18.3 |
8.0 |
172.3 |
17.7 |
92.0 |
18.3 |
6.7 |
174.3 |
||
±SD |
2.5 |
3.5 |
3.5 |
2.6 |
8.3 |
3.5 |
4.6 |
4.0 |
1.5 |
5.5 |
|||
Fold Increase |
0.8 |
1.0 |
0.8 |
0.8 |
1.0 |
0.7 |
0.9 |
0.9 |
0.6 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.5 |
Mean |
21.0 |
106.0 |
17.3 |
8.0 |
172.0 |
17.0 |
94.0 |
16.7 |
8.7 |
172.0 |
||
±SD |
1.7 |
7.5 |
3.2 |
3.6 |
7.2 |
3.6 |
9.0 |
3.1 |
2.5 |
9.5 |
|||
Fold Increase |
0.8 |
1.0 |
0.8 |
0.8 |
1.0 |
0.7 |
0.9 |
0.8 |
0.7 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.16 |
Mean |
19.3 |
102.0 |
18.0 |
8.7 |
174.0 |
18.0 |
90.3 |
19.7 |
7.7 |
169.7 |
||
±SD |
2.1 |
6.0 |
3.6 |
4.7 |
4.6 |
4.6 |
6.5 |
3.1 |
2.1 |
13.2 |
|||
Fold Increase |
0.8 |
1.0 |
0.8 |
0.8 |
1.0 |
0.8 |
0.9 |
0.9 |
0.6 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.05 |
Mean |
23.0 |
100.7 |
17.7 |
7.7 |
167.0 |
18.3 |
91.3 |
20.3 |
7.3 |
165.3 |
||
±SD |
2.0 |
12.4 |
2.5 |
2.9 |
13.5 |
2.1 |
10.5 |
4.0 |
3.1 |
9.1 |
|||
Fold Increase |
0.9 |
0.9 |
0.8 |
0.7 |
0.9 |
0.8 |
0.9 |
1.0 |
0.6 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
380.7 |
398.7 |
147.0 |
115.7 |
394.0 |
340.0 |
382.3 |
133.3 |
121.7 |
393.0 |
|
±SD |
18.9 |
9.3 |
9.6 |
9.7 |
18.7 |
21.7 |
10.0 |
4.5 |
10.4 |
11.5 |
|||
Fold Increase |
15.0 |
3.7 |
6.6 |
10.8 |
2.2 |
14.2 |
3.7 |
6.3 |
10.1 |
2.2 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
Values of Revertants are in Mean±SD
Positive controls:
For with S9:
ForSalmonella typhimuriumTA98, TA100, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene
ForEscherichia coliWP2 uvrA (pKM101)strain +S9 = 30µg/plate of 2-Aminoanthracene
For without S9:
For TA98: 2 µg/plate of 2-Nitrofluorene
For TA100 and TA1535: 1 µg/plate of Sodium azide.
For TA1537: 50 µg/plate of 9-Aminoacridine
ForEscherichia coliWP2 uvrA (pKM101): 5 µg/plate of4-Nitroquinoline N-oxide
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, it can be concluded that the test item Hostacerin DGSB, is “non-mutagenic” in the Bacterial Reverse Mutation Test up to the highest tested concentration of 5 mg/plate under the test condition.
- Executive summary:
The test item, Hostacerin DGSB obtained from Clariant India Limited,was evaluated for mutagenicity in Bacterial Reverse Mutation Test as per the OECD guidelinefor testing of chemicals No. 471, “Bacterial Reverse Mutation Test”, adopted on21stJuly 1997.
The tester strains used in the mutation assay were Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and Escherichia coliWP2 uvrA (pKM101).
The test concentrations tested in the mutation assay were selected based on the results of solubility, precipitation and initial cytotoxicity test. The two independent trials (trial I and II) were conducted by plate incorporation method and pre incubation method in the presence and absence of metabolic activation system. In mutation assay the test item was tested at the concentrations of0.05, 0.16, 0.50, 1.58 and 5mg/plate. Vehicle control (acetone) and appropriate positive controls (2-nitrofluorene, sodium azide and 9-Aminoacridine, 4-nitroquinoline 1-oxide for trials “without metabolic activation” and 2-Aminoanthracene for trials “with metabolic activation”) were tested simultaneously. On the basis of test item solubility and precipitation tests, the initial cytotoxicity test was performed at 0.7, 0.8, 0.9, 1, and 2 mg/plate. The follow-up initial cytotoxicity test was performed at the 1, 2, 2.25, 2.50, 2.75, 3, 4 and 5 mg/plate concentrations. Initial cytotoxicity test was performed with TA100 both in the presence and absence of metabolic activation system. For the tester strain TA100 treated with Hostacerin DGSB at the concentration of 5 mg/plate both in the presence and absence of metabolic activation no cytotoxicity and lawn reduction was observed. Hence on the basis of cytotoxicity results 5 mg/plate was considered as the highest test concentration for mutation assay.
From the experimental results obtained, the mean numbers of revertant colonies at the tested concentrations were comparable to those of the vehicle control, in both the trials, in the presence and absence of metabolic activation. There was no appreciable increase in number of revertant colonies at any of the tested concentrations in both the trials.The number of revertant colonies in the positive controls resulted in 2.2 to 15.0 fold increase under identical conditions.
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