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EC number: 404-740-9 | CAS number: 115895-09-5
- 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:
- Feb 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. No TA 102 or E. coli strain was tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- current version
- Deviations:
- yes
- Remarks:
- no TA 102 or E.coil strain was tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in May 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 404-740-9
- EC Name:
- -
- Cas Number:
- 115895-09-5
- Molecular formula:
- C26H40Cl2O5
- IUPAC Name:
- ethyl 3,5-dichloro-4-{[(hexadecyloxy)carbonyl]oxy}benzoate
- Details on test material:
- - Name of test material (as cited in study report): AF-366
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: at ambient temperature in the dark
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with 500 mg/kg bw Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1 and 2: 61.7, 185.2, 555.6, 1666.7 and 5000 μg/plate; TA 1535, TA 1537, TA 1538, TA 98 and TA 100; with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the vehicle was shown during the range-finding test to be suitable for use with the test substance
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (1 μg/plate, -S9, TA 1535 and TA 100); 9-aminoacridine (80 μg/plate, -S9, TA 1537); 2-nitrofluorene (2 μg/plate, -S9, TA 1538 and TA 98); 2 -aminoanthracene (2 μg/plate, +S9, TA 1535, TA 1538, TA 98 and TA 100; 5 μg/plate, +S9, TA 1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72 h
NUMBER OF REPLICATIONS: 3 replications in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
OTHER:
The ability of the S9-mix to activate compounds was shown with 4-amino-biphenyl and 2-aminoanthracene, using TA 98 as an indicator strain. The S9-mix was checked for sterility. - Evaluation criteria:
- A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose-response effect.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, 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
- Remarks:
- precipitation observed from 1666.7 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at concentrations of 1666.7 and 5000 μg/plate, the test substance precipitated in the plates
RANGE-FINDING/SCREENING STUDIES:
A range-finding assay with 0.001, 0.01, 0.1, 1.0, 10, 100 mg test substance/plate and the vehicle (DMSO) as negative control was performed to assess the toxicity of the test substance for S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100, with and without metabolic activation. No mutagenic or cytotoxic effects were observed. At 1 and 10 mg/plate the test substance precipitated (slightly) in the plates. Based on these results, 5 mg/plate was chosen as the highest concentration in the main experiment, with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of experiment 1
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
||
-S9 |
DMSO |
128 ± 20 |
21 ± 3 |
27 ± 4 |
22 ± 11 |
9 ± 6 |
-S9 |
61.7 |
142 ± 14 |
27 ± 6 |
30 ± 6 |
28 ± 9 |
9 ± 3 |
-S9 |
185.2 |
186 ± 11 |
29 ± 2 |
25 ± 4 |
20 ± 3 |
8 ± 2 |
-S9 |
555.6 |
159 ± 13 |
30 ± 2 |
28 ± 9 |
24 ± 6 |
6 ± 4 |
-S9 |
1666.7 |
185 ± 5 |
31 ± 3 |
29 ± 6 |
32 ± 17 |
4 ± 3 |
-S9 |
5000 |
161 ± 6 |
31 ± 2 |
28 ± 7 |
31 ± 5 |
10 ± 3 |
Positive controls, –S9 |
Name |
SA |
SA |
2-NF |
2-NF |
9-AA |
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
80 |
|
|
426 ± 43 |
289 ± 12 |
710 ± 25 |
542 ± 41 |
569 ± 56 |
|
|
|
|
|
|
|
|
+S9 |
DMSO |
140 ± 17 |
15 ± 9 |
44 ± 8 |
45 ± 2 |
10 ± 1 |
+S9 |
61.7 |
154 ± 12 |
19 ± 4 |
47 ± 21 |
54 ± 12 |
12 ± 1 |
+S9 |
185.2 |
129 ± 6 |
18 ± 9 |
48 ± 6 |
51 ± 4 |
11 ± 5 |
+S9 |
555.6 |
132 ± 6 |
20 ± 2 |
46 ± 8 |
51 ± 10 |
14 ± 3 |
+S9 |
1666.71 |
165 ± 17 |
17 ± 3 |
49 ± 3 |
56 ± 11 |
8 ± 1 |
+S9 |
50001 |
132 ± 8 |
22 ± 2 |
57 ± 12 |
40 ± 6 |
12 ± 4 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
5 |
|
|
1136 ± 84 |
352 ± 25 |
893 ± 60 |
827 ± 59 |
338 ± 112 |
9-AA = 9-aminoacridine
2-NF = 2-nitrofluorene
SA = sodium azide
2-AA = 2 -aminoanthracene
1precipitation
Table 2: Results of experiment 2
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
||
-S9 |
DMSO |
173 ± 5 |
21 ± 2 |
28 ± 5 |
30 ± 8 |
10 ± 1 |
-S9 |
61.7 |
158 ± 12 |
28 ± 3 |
19 ± 4 |
28 ± 9 |
9 ± 3 |
-S9 |
185.2 |
184 ± 12 |
27 ± 5 |
28 ± 8 |
29 ± 3 |
8 ± 3 |
-S9 |
555.6 |
188 ± 4 |
28 ± 4 |
26 ± 6 |
34 ± 4 |
10 ± 3 |
-S9 |
1666.7 |
175 ± 9 |
33 ± 3 |
27 ± 6 |
28 ± 12 |
7 ± 4 |
-S9 |
5000 |
167 ± 11 |
30 ± 3 |
33 ± 2 |
31 ± 3 |
11 ± 2 |
Positive controls, –S9 |
Name |
SA |
SA |
2-NF |
2-NF |
9-AA |
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
80 |
|
|
489 ± 85 |
391 ± 79 |
584 ± 55 |
543 ± 48 |
984 ± 87 |
|
|
|
|
|
|
|
|
+S9 |
DMSO |
126 ± 14 |
21 ± 4 |
56 ± 6 |
47 ± 7 |
10 ± 5 |
+S9 |
61.7 |
143 ± 33 |
21 ± 3 |
45 ± 13 |
57 ± 3 |
14 ± 3 |
+S9 |
185.2 |
145 ± 28 |
15 ± 2 |
55 ± 7 |
48 ± 4 |
15 ± 2 |
+S9 |
555.6 |
141 ± 34 |
22 ± 5 |
55 ± 4 |
53 ± 5 |
16 ± 1 |
+S9 |
1666.71 |
150 ± 4 |
20 ± 3 |
54 ± 11 |
55 ± 11 |
12 ± 2 |
+S9 |
50001 |
129 ± 19 |
21 ± 1 |
49 ± 7 |
43 ± 7 |
12 ± 2 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
5 |
|
|
1314 ± 25 |
382 ± 30 |
859 ± 37 |
882 ± 16 |
237 ± 21 |
9-AA = 9-aminoacridine
2-NF = 4-nitrofluorene
SA = sodium azide
2 -AA = 2 -aminoanthracene
1precipitation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
From the above findings it is concluded that AF-366 did not show mutagenic activity in Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 either in the absence or in presence of the S-9 mix, under the conditions employed in this evaluation.
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