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EC number: 295-458-3 | CAS number: 92045-76-6 A complex combination of hydrocarbons obtained from residual oils by solvent crystallisation and treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C25.
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2005-06-17 to 2005-06-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction by the because it was carried out in accordance with OECD Test Guideline 471 and is GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 8002-74-2
- Cas Number:
- 8002-74-2
- IUPAC Name:
- 8002-74-2
- Reference substance name:
- Paraffin waxes and Hydrocarbon waxes
- IUPAC Name:
- Paraffin waxes and Hydrocarbon waxes
- Test material form:
- liquid: viscous
- Details on test material:
- -Test Substance: CAS number: 8002-74-2 (100% purity)
Chemical name: aliphatic alkane
Other name: hydrocarbon wax
Appearance: solid, white, waxy
Batch/Lot Number: A053603
Molecular Formula: C(n)H(2n+2); Sasolwax 5203 contains alkanes ranging from C19 to C36. The man component is C26
Average Molecular Weight: 360
Melting point: 54°C
TNO Test Substance Number: 0500A9
Prior to administration, test substance was melted and extracted in DMSO at a concentration of 50 mg/ml Sasolwax 5203 for approximately 30 minutes at 60±2°C under agitation. After 30 minutes incubation, the wax was coagulated by incubation at 6°C for 8 minutes. The extract (DMSO aliquot) was collected. The test substance was melted again and extraction procedure was repeated. A light white extraction solution was obtained. The extracts were pooled and serial dilutions, separated by 3-fold intervals, in DMSO were prepared.
Constituent 1
Constituent 2
Method
- Target gene:
- No data reported.
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA98, 100, 1535, 1537 and E. coli WP 2 uvrA
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Wistar rat S9 homogenate
- Test concentrations with justification for top dose:
- Just before use, the test substance was extracted with DMSO at 50 mg/ml. The test substance was melted at approximately 60°C and extracted with half of the volume of vehicle needed, for 30 minutes at 60 ± 5°C under agitation. After the 30 minutes incubation, the wax was coagulated by incubation at ± 6°C for ± 8 minutes. The extract (DMSO aliquot) was collected. The test substance was melted again and extraction procedure was repeated. A light white extraction solution was obtained. The extracts were pooled and serial dilutions, separated by 3-fold intervals, in DMSO were prepared. A highest dose 100 % extract was tested. In total test five dose levels, ranging from 1.23 to 100 % of the extract were tested, which is comparable to 62 to 5000 μg of the test substance per plate, assuming a complete extraction. Nominal concentrations were used.
- Vehicle / solvent:
- dimethyl sulphoxide
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: In the absence of S9, positive controls were sodium azide 1.0 µg/plate, 9-aminoacridine 80.0 µg/plate, 2-nitrofluorene 2.0 µg/plate, N-ethyl-N-nitrosourea 100 µg/plate. In the presence of the S9 mix, 2-aminoanthracene 2.0 µg/plate, benzo(a)pyrene 4.0 µg
- Details on test system and experimental conditions:
- Briefly, the mutagenicity assay was carried out as follows. To 2 millilitres molten top agar (containing 0.6 % agar, 0.5 % NaCl and 0.05 mM L-histidine HCl/0.05 mM biotin for the S. typhimurium strains, and supplemented with 0.05 mM tryptophane for the E. coli WP2 uvrA strain), maintained at approximately 46°C, were added subsequently: 0.1 millilitres of a fully grown culture of the appropriate strain, 0.1 millilitres of the test substance extract, or of the negative or the positive control substance solution, and 0.5 millilitres S9-mix for the experiments with metabolic activation or 0.5 millilitres sodium phosphate 100 millimolar (pH 7.4) for the experiments without metabolic activation. The ingredients were thoroughly mixed, and the mix was immediately poured onto minimal glucose agar plates (1.5 % agar in Vogel and Bonner medium E with 2 % glucose). All determinations were made in triplicate. The plates were incubated at approximately 37°C for approximately 72 hours. Subsequently, the his+ and trp+ revertants were counted. Cytotoxicity is defined as a reduction (at least 50%) in the number of revertant colonies and/or a clearing of the background lawn of bacterial growth.
- Evaluation criteria:
- The mutagenicity study is considered valid if the mean colony counts of the control values of the strains were within acceptable ranges, if the results of the positive controls meet the criteria for a positive response, and if no more than 5% of the plates are lost through contamination or other unforeseen events.
A test substance is considered to be positive in the bacterial gene mutation test if there is a concentration-related increase in the mean number of revertants colonies on the test plates of if a reproducible two-fold or more increase is observed to that on the negative
control plates.
A test substance is considered to be negative in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points. - Statistics:
- No statistic analyses were performed.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium strains TA 1535, TA 1537, TA 98, and TA 100; E. coli strain WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Extract of Sasolwax 5203 was slightly toxic, in the presence and absence of S9-mix, to TA 1537 at and above 33.3% of the extract, and to TA 98 at 100% of the extract, as was evidenced by a slightly less dense background lawn compared to the negative control. In both the absence and presence of S9-mix in all strains, the extract of Sasolwax 5203 did not cause a dose-related or more than two-fold increase in the mean number of revertant colonies appearing in the test plates compared to the background spontaneous reversion rate observed with the negative control. The mean number of his+ and trp+ revertant colonies of the negative controls were within the acceptable range, and the positive controls gave the expected increase in the mean number of revertant colonies.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Dose (% of extract) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E. coli |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0% |
24 |
19 |
2 |
16 |
26 |
47 |
118 |
133 |
44 |
38 |
25 |
20 |
13 |
17 |
34 |
42 |
142 |
144 |
38 |
42 |
|
24 |
17 |
19 |
30 |
34 |
49 |
120 |
133 |
43 |
41 |
|
Mean |
24 |
19 |
11 |
21 |
31 |
46 |
127 |
137 |
42 |
40 |
StDev |
1 |
2 |
9 |
8 |
5 |
4 |
13 |
6 |
3 |
2 |
1.23% |
34 |
16 |
17 |
22 |
34 |
38 |
103 |
130 |
35 |
38 |
26 |
24 |
17 |
28 |
28 |
46 |
143 |
136 |
34 |
32 |
|
25 |
25 |
*** |
24 |
28 |
50 |
118 |
144 |
29 |
40 |
|
Mean |
28 |
22 |
17 |
25 |
30 |
45 |
121 |
137 |
33 |
37 |
StDev |
5 |
5 |
0 |
3 |
3 |
6 |
20 |
7 |
3 |
4 |
3.70% |
23 |
13 |
12 |
20 |
28 |
50 |
100 |
137 |
28 |
42 |
23 |
18 |
13 |
25 |
37 |
44 |
115 |
150 |
34 |
44 |
|
22 |
19 |
22 |
25 |
37 |
74 |
126 |
124 |
36 |
53 |
|
Mean |
23 |
17 |
16 |
23 |
34 |
56 |
114 |
137 |
33 |
46 |
StDev |
1 |
3 |
6 |
3 |
5 |
16 |
13 |
13 |
4 |
6 |
11.10% |
24 |
16 |
10 |
20 |
31 |
37 |
129 |
154 |
35 |
50 |
25 |
11 |
16 |
34 |
37 |
53 |
121 |
154 |
40 |
43 |
|
32 |
18 |
12 |
14 |
43 |
40 |
107 |
150 |
38 |
36 |
|
Mean |
27 |
15 |
13 |
23 |
37 |
43 |
119 |
153 |
38 |
43 |
StDev |
4 |
4 |
3 |
10 |
6 |
9 |
11 |
2 |
3 |
7 |
33.30% |
26 |
14 |
11 |
35 |
36 |
36 |
138 |
138 |
32 |
34 |
26 |
18 |
13 |
12 |
24 |
49 |
125 |
101 |
38 |
34 |
|
22 |
13 |
22 |
19 |
34 |
56 |
137 |
148 |
37 |
43 |
|
Mean |
25 |
15 |
15 |
22 |
31 |
47 |
133 |
129 |
36 |
37 |
StDev |
2 |
3 |
6 |
12 |
6 |
10 |
7 |
25 |
3 |
5 |
100% |
30 |
16 |
7 |
20 |
28 |
41 |
151 |
121 |
35 |
37 |
25 |
14 |
8 |
24 |
32 |
50 |
129 |
109 |
31 |
40 |
|
29 |
13 |
13 |
13 |
30 |
55 |
151 |
136 |
44 |
34 |
|
Mean |
28 |
14 |
9 |
19 |
30 |
49 |
144 |
122 |
37 |
37 |
StDev |
3 |
2 |
3 |
6 |
2 |
7 |
13 |
14 |
7 |
3 |
Pos. Control |
527 |
402 |
1631 |
165 |
889 |
730 |
728 |
1493 |
*** |
921 |
530 |
452 |
3461 |
159 |
*** |
691 |
722 |
1517 |
288 |
1129 |
|
539 |
380 |
3266 |
156 |
1086 |
500 |
694 |
1569 |
333 |
1058 |
|
Mean |
532 |
411 |
2786 |
160 |
988 |
640 |
715 |
1526 |
311 |
1036 |
StDev |
6 |
37 |
1005 |
5 |
139 |
123 |
18 |
39 |
32 |
106 |
Mean: Average number of revertants per plate (bolded)
StDev: Standard deviation
S9: Liver homogenate from rats treated with aroclor
Pos. Control Positive control
*** Not counted due to contamination
Underlined values have slightly less dense background lawn of bacterial
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the results obtained in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and the presence of the S9-mix, indicate that the extract of Sasolwax 5203 is not mutagenic under the conditions employed in this study.
- Executive summary:
In a reverse gene mutation assay in bacteria, strains of S. typhimurium (TA 1535, TA 1537, TA 98, TA 100) andE. coli (WP 2 uvrA) were exposed to extracted Sasolwax 5203 in DMSO. A highest dose of 100% extract was tested. In total, five dose levels ranging from 1.23 to 100% of the extract were tested, which is comparable to nominal concentrations of 62 to 5000 μg of the test substance per plate. The positive controls induced the appropriate response in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out in accordance with OECD Test Guideline 471 and is GLP compliant.
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