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EC number: 287-634-3 | CAS number: 85566-24-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 06 - 15 Sep 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions. No TA 102 or E.coli strains were 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)
- Deviations:
- yes
- Remarks:
- no TA 102 or E.coli strains were tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- no TA 102 or E.coli strains were tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C8-10, C12-18-alkyl esters
- EC Number:
- 306-082-7
- EC Name:
- Fatty acids, C8-10, C12-18-alkyl esters
- Cas Number:
- 95912-86-0
- Molecular formula:
- Not applicable, substance is UVCB
- IUPAC Name:
- 95912-86-0
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 1538
- 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: 8, 40, 200, 1000 and 5000 µg/plate without metabolic activation; 16, 80, 400, 1000 and 5000 µg/plate with metabolic activation
Experiment 2: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/aqua bidest.
- Justification for choice of solvent/vehicle: the vehicle was chosen according to the solubility properties tested before the start of the study
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (2.5 µg/plate, ± S9, TA 100, TA 1535); 9 -aminoacridine (80 µg/plate, ± S9, TA 1537); 4 -nitro-o-phenylenediamine (40 µg/plate, ± S9, TA98, TA 1538); 2 -aminoanthracene (5.0 µg/plate ± S9, TA 1535, TA 1537; 2.5 µg/plate, ± S9, TA 98, TA 100)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 12 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
OTHER: The test batches containing S9-mix were controlled for sterility by adding 0.5 ml S9-mix to untreated agar plates. The microsomal enzyme activity was examined with 2-amino-anthracene and benzo(a)pyrene on TA 98 and in a cytogenetic test with cyclophosphamide. - Evaluation criteria:
- A combination of the following criteria was considered as a positive result:
- The plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range (see Table 1 under 'any other information on materials and method including tables')
- As a rule, the positive control showed mutation rates exceding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.0
- At more than one dose tested, the test substance caused at least a 2.0 fold increase in comparison with the negative controls in the tester strain S. typhimurium TA 100. For the other tester strains used, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Yes, the spontaneous mutation rate of each tester strain per plate were within the characteristic spontaneous mutation range (see Table 1).
ADDITIONAL INFORMATION ON CYTOTOXICITY: cytotoxicity was observed at 5000 µg/plate - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2: Test 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 |
||
Negative controls, –S9 |
Culture medium and Tween 80/aqua bidest. |
64.4 ± 11.4 |
10.0 ± 3.5 |
9.6 ± 2.9 |
23.8 ± 3.1 |
5.5 ± 1.3 |
– |
8 |
67.6 ± 4.5 |
13.3 ± 2.5 |
10.0 ± 1.0 |
29.0 ± 4.3 |
9.6 ± 2.8 |
- |
40 |
78.3 ± 12.0 |
9.0 ± 4.0 |
10.0 ± 1.0 |
29.3 ± 1.5 |
5.0 ± 2.6 |
- |
200 |
79.5 ± 23.3* |
7.0 ± 3.0 |
9.6 ± 2.5 |
22.6 ± 4.7 |
8.0 ± 6.0 |
– |
1000 |
80.6 ± 17.0 |
8.6 ± 3.5 |
11.6 ± 3.2 |
31.0 ± 2.6 |
6.0 ± 1.0 |
– |
5000 |
55.6 ± 9.4 |
8.6 ± 2.3 |
8.3 ± 0.5 |
29.6 ± 5.5 |
8.6 ± 2.8 |
Positive controls, –S9 |
Name |
SA |
SA |
4-NP |
4-NP |
9-AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
266.3 ± 32.3 |
573.0 ± 32.6 |
1871.3 ± 40.8 |
968.6 ± 144.3 |
218 ± 100.9 |
|
Positive controls, –S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
56.5 ± 2.1* |
10.6 ± 1.1 |
16.6 ± 4.0 |
26.3 ± 7.2 |
7.0 ± 3.4 |
|
Negative controls, +S9 |
Culture medium and Tween 80/aqua bidest. |
84.6 ± 17.9 |
12.0 ± 2.5 |
11.3 ± 1.8 |
18.0 ± 3.5 |
7.5 ± 3.3 |
+ |
16 |
71.3 ± 2.0 |
14.0 ± 2.6 |
14.3 ± 0.5 |
22.3 ± 3.5 |
4.6 ± 2.0 |
+ |
80 |
81.3 ± 11.5 |
10.3 ± 1.5 |
9.3 ± 0.5 |
23.6 ± 2.0 |
7.0 ± 3.0 |
+ |
400 |
89.3 ± 2.0 |
13.3 ± 5.5 |
13.6 ± 4.9 |
24.0 ± 3.6 |
7.0 ± 1.7 |
+ |
1000 |
94.6 ± 12.5 |
13.0 ± 2.6 |
9.0 ± 2.0 |
22.6 ± 2.0 |
4.0 ± 2.6 |
+ |
5000 |
100.0 ± 3.6 |
15.6 ± 3.0 |
9.0 ± 1.0 |
15.0 ± 3.0 |
5.0 ± 4.0 |
Positive controls, +S9 |
Name |
SA |
SA |
4-NP |
4-NP |
9AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
140.0 ± 18.7 |
20.6 ± 2.5 |
19.6 ± 2.8 |
721.3 ± 38.8 |
196.0 ± 67.6 |
|
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1100.3 ± 55.1 |
438.0 ± 33.4 |
162.0 ± 22.5 |
884.0 ± 114.0 |
46.3 ± 9.0 |
9-AA = 9-aminoacridine
4-NP = 4-nitro-o-phenylenediamine
SA = sodium azide
2AA = 2-Aminoanthracene
* contamination of 1 plate
Table 3: Test 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 |
||
Negative controls, –S9 |
Culture medium and Tween 80/aqua bidest. |
113.1± 12.7 |
9.8± 3.7 |
11.8± 3.3 |
47.6± 4.4 |
8.0± 1.0
|
– |
8 |
108.6± 7.0 |
10.0± 2.8 |
9.6± 3.7 |
48.6± 12.5 |
7.6± 3.0 |
- |
40 |
109.6± 6.4 |
9.3± 4.3 |
11.3± 0.5 |
43.3± 8.6 |
6.6± 1.1 |
- |
200 |
99.5± 6.3 |
14.6± 5.6 |
13.0± 6.0 |
47.0± 11.5 |
7.0± 2.6 |
– |
1000 |
115.0± 14.1 |
11.0± 1.1 |
12.0± 3.4 |
49.0± 7.2 |
9.0± 2.0 |
– |
5000 |
114.3± 9.2 |
6.3± 2.8 |
9.6± 2.0 |
44.0± 7.2 |
11.0± 3.6 |
Positive controls, –S9 |
Name |
SA |
SA |
4-NP |
4-NP |
9-AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
645.3± 56.1 |
388.6± 15.9 |
2167.3± 101.2 |
1103.3± 162.4 |
91.0± 19.5 |
|
Positive controls, –S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
107.3± 6.6 |
7.6± 2.3 |
18.6± 8.5 |
54.6± 3.2 |
9.6± 2.5 |
|
Negative controls, +S9 |
Culture medium and Tween 80/aqua bidest. |
109.0± 10.0 |
15.1± 4.0 |
24.1± 1.9 |
61.3± 7.9 |
6.8± 2.9 |
+ |
8 |
92.3± 17.0 |
11.0± 2.6 |
27.3± 2.5 |
69.6± 14.5 |
9.6± 0.5 |
+ |
40 |
116.0± 7.0 |
12.3± 3.2 |
29.6± 1.5 |
59.3± 3.2 |
7.0± 1.7 |
+ |
200 |
104.0± 16.3 |
12.6± 4.9 |
27.0± 6.5 |
68.6± 8.0 |
7.3± 1.1 |
+ |
1000 |
118.6± 5.1 |
14.6± 5.5 |
25.3± 3.5 |
70.6± 8.0 |
7.6± 3.0 |
+ |
5000 |
113.6± 25.7 |
9.3± 3.0 |
28.6± 1.5 |
75.3± 3.2 |
12.6± 1.5 |
Positive controls, +S9 |
Name |
SA |
SA |
4-NP |
4-NP |
9AA |
Concentrations (μg/plate) |
2 |
2 |
40 |
40 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
202.0± 16.0 |
178.3± 7.6 |
1487.0± 128.0 |
736.3± 7.9 |
65.0± 15.0 |
|
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
5 |
2.5 |
5 |
5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1337.6± 47.5 |
194.6± 24.9 |
1515.0± 171.6 |
1100.6± 47.5 |
87.6± 17.6 |
9-AA = 9-aminoacridine
4-NP = 4-nitro-o-phenylenediamine
SA = sodium azide
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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