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EC number: 266-037-1 | CAS number: 65997-01-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-08-22 to 2005-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Crude Tall Oil
- IUPAC Name:
- Crude Tall Oil
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- see Table 1
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: DMSO is a common vehicle for the Ames test.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine
- Remarks:
- TA97a without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- TA97a with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 and TA1535 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA98, TA100 and TA1535 with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: t-Butyl-hydroperoxide
- Remarks:
- TA102 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxy-anthraquinone
- Remarks:
- TA102 with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: triplicate for each dose group, six replicates for the solvent controls and three replicates for positive control.
DETERMINATION OF CYTOTOXICITY
- Method: other: reduced or no bacterial background lawn, microcolonies of bacteria instead of a homogenous background lawn, clearly reduced number of revertant colonies. - Evaluation criteria:
- A result would be considered positive if there was a reproducible increase in the number of revertants to more than 2.5 fold for strains TA98 and TA1538 and more than 1.33 fold for TA97a, TA100 and TA102.
- Statistics:
- The number of revertant colonies was counted by hand in strains TA98 and TA1535 and by a computer program in strains TA97a, TA100 and TA102. The mean and standard deviation of replicate results were calculated.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 185 μg/plate to strain TA97a
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A precipitate was visible at 556 μg/plate samples and above. The precipitate was still visible at 5000 μg/plate when the colonies were counted but did not impede the counting.
- Other confounding effects: the substance is known to be ready biodegradable.
RANGE-FINDING/SCREENING STUDIES: see Table 2
COMPARISON WITH HISTORICAL CONTROL DATA: numbers of spontaneous revertants are comparable with the historic control data for the negative controls.
Any other information on results incl. tables
Table 2: Dose range-finding study. Number of revertants per plate (average of 2 plates).
|
TA 100 |
|
Concentration (μg/Plate) |
- MA |
Cytotoxic (Yes/No) |
21 |
93 |
No |
62 |
93 |
No |
185 |
81 |
No |
556 |
58 |
No |
1667 |
59 |
No |
5000 |
75 |
No |
Table 3: Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates in solvent control, mean of 3 plates in the other exposure).
|
TA97a |
TA98 |
TA100 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
5000 |
- |
- |
Yes |
6.0 |
9.0 |
No |
42.7 |
46.3 |
No |
1667 |
0.0 |
9.7 |
Yes |
8.7 |
9.3 |
No |
44.3 |
48.0 |
No |
556 |
0.0 |
54.7 |
Yes |
6.3 |
8.0 |
No |
52.0 |
56.3 |
No |
185 |
67.7 |
110.3 |
No |
11.0 |
11.0 |
No |
66.3 |
69.7 |
No |
62 |
119.3 |
120.3 |
No |
9.3 |
9.3 |
No |
66.0 |
79.0 |
No |
0* |
607.0 |
140.5 |
No |
8.0 |
12.8 |
No |
73.5 |
77.0 |
No |
Positive control |
374.0 |
607.0 |
No |
109.7 |
415.7 |
No |
422.3 |
1955.0 |
No |
*solvent control with DMSO
Table 3 (continued): Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates in the solvent control, mean of 3 plates in the other exposures).
|
TA102 |
TA1535 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
5000 |
66.3 |
127.0 |
Yes |
7.0 |
4.3 |
Yes |
1667 |
85.0 |
152.7 |
Yes |
7.3 |
7.7 |
Yes |
556 |
102.7 |
198.0 |
No |
11.0 |
10.7 |
No |
185 |
117.0 |
244.3 |
No |
22.0 |
16.3 |
No |
62 |
170.3 |
260.7 |
No |
17.7 |
18.7 |
No |
0* |
181.7 |
247.8 |
No |
20.0 |
18.2 |
No |
Positive control |
487.7 |
595.0 |
No |
207.0 |
196.7 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Mutagenicity Assay. Number of revertants per plate) mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA97a |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
556 |
4.3 |
8.3 |
Yes |
185 |
32.7 |
102.7 |
No |
62 |
102.3 |
108.3 |
No |
21 |
110.0 |
103.7 |
No |
7 |
109.3 |
135.0 |
No |
2.3 |
118.0 |
122.7 |
No |
0* |
85.8 |
110.7 |
No |
Positive control |
229.7 |
351.7 |
No |
*solvent control with DMSO
Table 4 (continued): Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA98 |
TA100 |
TA100 |
||||||
Conc. |
— MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
5000 |
6.3 |
7.3 |
No |
54.7 |
56.0 |
No |
54.7 |
56.0 |
No |
1667 |
5.7 |
6.7 |
No |
57.3 |
61.3 |
No |
57.3 |
61.3 |
No |
556 |
5.3 |
8.0 |
No |
59.0 |
68.0 |
No |
59.0 |
68.0 |
No |
185 |
5.7 |
10.7 |
No |
69.0 |
79.0 |
No |
69.0 |
79.0 |
No |
62 |
5.3 |
11.3 |
No |
69.0 |
77.0 |
No |
68.0 |
77.0 |
No |
0* |
7.7 |
11.8 |
No |
86.5 |
69.5 |
No |
86.5 |
69.5 |
No |
Positive control |
207.3 |
359.3 |
No |
253.0 |
1372.0 |
No |
253.0 |
1372.0 |
No |
*solvent control withDMSO
Table 4 (continued): Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 6 plates per solvent control, mean of 3 plates in other exposures).
|
TA102 |
TA1535 |
||||
Conc. |
—MA |
+MA |
Cytotoxic |
—MA |
+MA |
Cytotoxic |
5000 |
34.7 |
85.3 |
Yes |
5.0 |
4.7 |
Yes |
1667 |
45.3 |
100.3 |
Yes |
6.3 |
7.3 |
Yes |
556 |
51.3 |
125.7 |
Yes |
10.7 |
12.0 |
No |
185 |
80.0 |
149.7 |
No |
15.0 |
17.0 |
No |
62 |
86.0 |
166.3 |
No |
183 |
19.7 |
No |
0* |
112.5 |
147.8 |
No |
15.7 |
17.7 |
No |
Positive control |
344.0 |
615.0 |
No |
158.0 |
163.0 |
No |
Applicant's summary and conclusion
- Conclusions:
- The test substance did not produce an increase in the number of revertants in S. typhimurium (strains TA97a, TA98, TA100, TA102 and TA1535) when tested under GLP to OECD 471 (2000). The test material was therefore considered to be non-mutagenic under the conditions of this test.
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