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EC number: 284-660-7 | CAS number: 84961-70-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 69522-75-4
- Cas Number:
- 69522-75-4
- IUPAC Name:
- 69522-75-4
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from livers of aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- 0.001, 0.004, 0.02, 0.10, 0.30, 1.00 mg/plate
- Vehicle / solvent:
- acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline-N-oxide, 2-acetylaminofluorene, benzo(a)pyrene, NaNO2, 2-aminoanthracene, 9-aminoacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
0.1 ml of bacterial culture, test solution, and, for tests with metabolic activation, 0.5 ml S-9 mix, were mixed with 2 ml top agar, then poured into minimal glucose agar plates.
DURATION
- Exposure duration: 48 hrs, incubated at 37°C
NUMBER OF REPLICATIONS: 3
OTHER: For plates with more than 500 revertant,colonies/plates, number of revertant colonies were counted using a stereomicroscope. An Artek model 880 automatic colony counter was used for other plates. Visual examination was used for plates with <10 revertants/plate. - Evaluation criteria:
- A positive response was considered to be three treatment levels with revertants/plate greater than solvent control and a significant positive dose response (p<0.01).
- Statistics:
- Analyses included Bartlett's test, one-sided t-test, Grubb's test, and regression analysis.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: test substance was not soluble at concentrations above 1 mg/plate
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity tests show the test substance was not cytotoxic at concentrations up to 10 mg/plate. This was higher than the solubility of the test substance. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results for TA1538 and TA1537 – Experiment I (Revertants/plate (SD))
Concentration (mg/plate) |
TA1535 – Without S9 |
TA1535 – With S9 |
TA1537 – Without S9 |
TA1537 – Without S9 |
0.001 |
17.3 (6.8) |
7.0 (3.6) |
7.0 (4.0) |
4.3 (2.1) |
0.004 |
15.0 (2.6) |
9.3 (3.1) |
6.3 (3.2) |
7.0 (3.0) |
0.02 |
18.0 (3.0) |
9.0 (2.6) |
6.3 (0.6) |
7.0 (1.7) |
0.10 |
13.7 (4.0) |
8.3 (0.6) |
6.0 (2.0) |
6.7 (3.1) |
0.30 |
18.0 (5.3) |
10.3 (4.0) |
3.7 (2.9) |
5.7 (1.5) |
1.00 |
18.7 (6.1) |
11.0 (5.2) |
3.0 (2.0) |
3.3 (1.2) |
Solvent Control |
12.4 (4.9) |
9.4 (1.9) |
7.7 (2.5) |
7.6 (3.6) |
Non-solvent Control |
9 |
3 |
7 |
4 |
Positive Control 0.001-0.5 |
100 |
51 |
8 |
29 |
Positive Control 0.005-2.5 |
286 |
271 |
5 |
138 |
Positive Control 0.01-5 |
347 |
304 |
46 |
Toxicity Observed |
Results for TA1538 and TA1537 – Experiment II (Revertants/plate (SD))
Concentration (mg/plate) |
TA1535 – Without S9 |
TA1535 – With S9 |
TA1537 – Without S9 |
TA1537 – Without S9 |
0.001 |
18.3 (4.2) |
10.3 (1.2) |
8.0 (1.0) |
9.7 (4.7) |
0.004 |
19.7 (3.5) |
13.3 (1.5) |
6.0 (2.6) |
9.7 (5.5) |
0.02 |
14.3 (3.2) |
13.0 (3.5) |
7.0 (1.7) |
13.3 (0.6) |
0.10 |
15.3 (9.2) |
10.7 (1.5) |
10.3 (3.1) |
11.0 (2.6) |
0.30 |
18.7 (1.5) |
9.0 (1.7) |
6.7 (1.5) |
12.0 (4.6) |
1.00 |
19.7 (5.5) |
10.7 (2.3) |
10.0 (4.4) |
13.0 (2.6) |
Solvent Control |
16.6 (2.1) |
10.8 (2.7) |
8.6 (2.9) |
11.6 (3.0) |
Non-solvent Control |
17 |
12 |
9 |
8 |
Positive Control 0.001-0.5 |
101 |
77 |
12 |
43 |
Positive Control 0.005-2.5 |
421 |
262 |
21 |
237 |
Positive Control 0.01-5 |
2100 |
399 |
180 |
Toxicity Observed |
Results for TA98 and TA100 – Experiment I (Revertants/plate (SD))
Concentration (mg/plate) |
TA98 – Without S9 |
TA98 – With S9 |
TA100 – Without S9 |
TA100 – Without S9 |
0.001 |
13.7 (4.6) |
40.7 (6.4) |
85.7 (5.9) |
92.3 (1.5) |
0.004 |
13.3 (1.5) |
30.3 (10.0) |
84.3 (15.0) |
95.0 (15.9) |
0.02 |
13.7 (1.5) |
38.0 (4.6) |
84.3 (5.1) |
87.0 (11.1) |
0.10 |
13.3 (4.0) |
31.0 (7.0) |
92.5 (3.5) |
86.3 (14.5) |
0.30 |
11.7 (1.2) |
29.7 (6.4) |
97.7 (8.4) |
96.0 (4.6) |
1.00 |
15.7 (5.3) |
40.0 (10.4) |
93.3 (2.9) |
104.0 (21.7) |
Solvent Control |
12.4 (4.9) |
39.6 (8.4) |
84.2 (8.3) |
91.4 (9.2) |
Non-solvent Control |
20 |
39 |
100 |
106 |
Positive Control 0.002-0.01 |
33 |
287 |
118 |
204 |
Positive Control 0.001-0.05 |
30 |
1800 |
145 |
805 |
Positive Control 0.02-0.1 |
69 |
3800 |
204 |
1200 |
Results for TA98 and TA100 – Experiment II (Revertants/plate (SD))
Concentration (mg/plate) |
TA98 – Without S9 |
TA98 – With S9 |
TA100 – Without S9 |
TA100 – Without S9 |
0.001 |
15.0 (2.0) |
35.0 (3.0) |
82.7 (2.1) |
89.0 (11.5) |
0.004 |
20.0 (4.4) |
40.0 (6.1) |
83.0 (3.6) |
84.7 (2.1) |
0.02 |
18.0 (6.6) |
37.0 (2.0) |
92.7 (16.8) |
88.3 (8.1) |
0.10 |
23.3 (3.2) |
33.3 (8.0) |
84.0 (21.5) |
93.7 (12.2) |
0.30 |
19.0 (1.0) |
30.3 (1.2) |
89.0 (7.8) |
97.7 (15.2) |
1.00 |
19.0 (2.6) |
36.3 (7.1) |
98.7 (15.6) |
101.3 (5.7) |
Solvent Control |
19.2 (4.1) |
35.0 (5.3) |
83.2 (9.3) |
78.9 (10.6) |
Non-solvent Control |
20 |
31 |
95 |
108 |
Positive Control 0.002-0.01 |
26 |
413 |
86 |
230 |
Positive Control 0.001-0.05 |
45 |
900 |
157 |
1200 |
Positive Control 0.02-0.1 |
73 |
1500 |
152 |
1900 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not cytotoxic or mutagenic either in the presence or absence of metabolic activation. - Executive summary:
This study examined the potential mutagenicity of the test substance Therminol 55 Heat-Transfer Medium. Concentrations of 0.001, 0.004, 0.02, 0.10, 0.30, 1.00 mg/plate of test substance were added to bacterial cultures of Salmonella strains TA 1535, TA 1537, TA 100, and TA 98. 4-nitroquinoline-N-oxide, 2-acetylaminofluorene, benzo(a)pyrene, NaNO2, 2-aminoanthracene, and 9 -aminoacridine were used as positive control substances. Acetone was used as a solvent. The test substance was also tested for cytotoxicity at concentrations up to 10 mg/plate, higher than the solubility limit of 1 mg/plate. Results show the test substance was not cytotoxic even at 10 mg/plate. Results also show no statistically significant increase in the number of revertants/plate in any of the strains at any concentration. The test substance is not mutagenic either in the presence or absence of metabolic activation.
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