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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
A series of key studies using different methods demonstrate that HAB is not mutagenic. The first study examined the mutagenic potential of HAB using the Ames test. Salmonella typhimurium strains TA1538, TA1537, TA1535, TA98, and TA100, were exposed to concentrations of 8, 40, 200, 1000, 5000 ug/plate of test substance in acetone in both the presence and absence of S9. Positive control substances were nitroflourene, sodium azide, or aminoacridine. Cultures were tested in triplicate for mutation frequency. No treatment cultures showed mutation frequencies significantly greater than negative controls. Positive controls responded as expected, therefore the test was valid. The test substance is not mutagenic in either the presence or absence of metabolic activation.
In the second study, HAB concentrations of 0.001, 0.004, 0.02, 0.10, 0.30, 1.00 mg/plate were added to bacterial cultures of Salmonella strains TA 1535, TA 1537, TA 100, and TA 98. The positive control substances were 4-nitroquinoline-N-oxide, 2-acetylaminofluorene, benzo(a)pyrene, NaNO2, 2-aminoanthracene, and 9 -aminoacridine. 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.
The third study examined the potential for HAB to cause chromosomal aberrations. In accordance with standard OECD guidelines, Chinese hamster ovary (CHO) cells were exposed to concentrations of 5.0 - 80.0 nl/ml (ppm) of test substance both in the presence and absence of metabolic activation. Preparation of chromosomes was done 7 hours (high dose), 24 hours (low, medium, and high dose) and 30 hours (high dose) after start of treatment with the test material. The treatment interval was 4 hours. Treatment was performed with the following test concentrations, with and without S9 activation:
7h: 10, 30, 60, 80 nL/mL
24h: 1, 5, 10, 30, 60, 80 nL/mL
30h: 10, 30, 60, 80 nL/mL
In each experimental group two parallel cultures were used. After the exposure period, the cells were examined for chromosomal aberrations. Ethylmethanesulfonate and cyclophosphamide were used as positive control substances. No increases in chromosomal aberrations were seen in either the presence or absence of metabolic activation. The test substance is not mutagenic.
The fourth study examined the potential for the test substance to be clastogenic. Chinese hamster ovary (CHO) cells were exposed to concentrations of 50, 100, 500, 1000, 4000 ug/ml of test substance for 24 hrs. After the exposure period, the cells were fixed, and examined under a microscope for cytotoxicity and chromosomal aberrations. The only positive result in exposure groups was at the 1000 ug/ml dose. Since a positive result was not seen at the 4000 ug/ml dose level, the test substance was considered not clastogenic. These findings were confirmed by an independent lab. No cytotoxicity was seen at any dose level.
The fifth study examined the potential of the test substance to be mutagenic in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0, 100, 250, 500, 750, and 1000 ug/ml of test substance in both the presence and absence of metabolic activation. Benzo(a)pyrene and ethylmethylsulfonate were used as positive control substances. No biologically significant results were seen in any treatment groups. The test substance was not mutagenic in either the presence or absence of metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 13, 1989-Jan. 19, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- 5.0 - 80.0 nl/ml
- Vehicle / solvent:
- ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate, cyclophosphamide
- Details on test system and experimental conditions:
- The study was conducted using standard OECD protocols. Preparation of chromosomes was done 7 hours (high dose), 24 hours (low, medium, and high dose) and 30 hours (high dose) after start of treatment with the test material. The treatment interval was 4 hours. Treatment was performed with the following test concentrations, with and without S9 activation:
7h: 10, 30, 60, 80 nL/mL
24h: 1, 5, 10, 30, 60, 80 nL/mL
30h: 10, 30, 60, 80 nL/mL
In each experimental group two parallel cultures were used. - Evaluation criteria:
- Per culture 100 metaphases were scored for structural chromosomal aberrations.
- Statistics:
- Statistical significance was evaluated using the chi-square test (p<0.05).
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No significant differences between aberration rates in the treatments vs. the controls was observed. The mitotic index was not, or only slightly, reduced after treatment with the highest dose level.
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
This study examined the potential for the test substance to cause mutations. Chinese hamster ovary (CHO) cells were exposed to concentrations of 5.0 - 80.0 nl/ml of test substance both in the presence and absence of metabolic activation. After the exposure period, the cells were examined for chromosomal aberrations. Ethylmethanesulfonate and cyclophosphamide were used as positive control substances. No increases in chromosomal aberrations were seen in either the presence or absence of metabolic activation. The test substance is not mutagenic.
- 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:
- Nov. 25, 1992-Dec. 21, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: The study was conducted following the standard test method based on Guideline 84/449/EWG B.14, with and without Arochlor-derived metabolic activation.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000, 5000 µg/plate
- Vehicle / solvent:
- Acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: nitroflourene, sodium azide, or aminoacridine
- Details on test system and experimental conditions:
- DURATION
- Preincubation period: 30 minutes at 30 ± 1°C
- Exposure duration: 96 hr, 37°C
NUMBER OF REPLICATIONS: 3
- Evaluation criteria:
- Dose-related response with significant increase over negative controls. Test is valid if there is a significant increase in mutation frequency in positive controls as compared to negative controls.
- Statistics:
- Statistics were determined using software from BIOSYS.
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Precipitation: precipitation was observed at the 5000 µg/plate concentration
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
This study examined the mutagenic potential of the test substance. Salmonella typhimuirum strains TA1538, TA1537, TA1535, TA98, and TA100, were exposed to concentrations of 8, 40, 200, 1000, 5000 ug/plate of test substance in acetone in both the presence and absence of S9. Positive control substances were nitroflourene, sodium azide, or aminoacridine. Cultures were tested in triplicate for mutation frequency. No treatment cultures showed mutation frequencies significantly greater than negative controls. Positive controls showed significantly greater mutation frequencies over negative controls, therefore the test was valid. The test substance is not mutagenic in either the presence or absence of metabolic activation.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- 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
- 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
- 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.
- 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
- 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.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: Preston, RJ, Au, W, Bender, MA, Brewen, JG, Carrano, AV, Heddle, JA, McFee, AF, Wolff, S, and Wassom, JS. 1981. Mammalian in vivo and in vitro cytogenetics assays: A report of the US Gene-Tox Program. Mutation Res. 87: 143-188.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- Study I - 50, 100, 500, 1000, 4000 µg/ml
Study II - 600, 1000, 4000 µg/ml - Vehicle / solvent:
- acetone
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: cyclophosphamide, methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 500,000 cells were seeded in flasks and pre-incubated for 18-24 hrs. Medium and test solution were added on the day of the test. Cells were incubated for 24 hrs.
DURATION
- Preincubation period: 18-24 hrs
- Exposure duration: 24 hrs
- Fixation time (start of exposure up to fixation or harvest of cells): 24.25 hrs
STAIN (for cytogenetic assays): Hoescht and Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 500 for mitotic index, 100 for average cell generation time
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- The statistical significance level was p <=0.05.
- Statistics:
- Number of cells with structural aberrations: Chi-square analysis
Structural aberrations per cell: Dunnett's t-test - Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- A statistically significant increase in structural aberrations was seen at the 1000 µg/ml dose level. However, no increase in structural aberrations was seen at the 4000 µg/ml dose level. Due to the errant results at the 1000 µg/ml dose level, the slides from the experiment were sent to an independent lab, Pharmakon Research International, for independent verification of the results. This lab re-analyzed the slides for chromosome aberrations, and performed an independent statistical analysis based on their results. The conclusion of the independent lab was that since the only positive result was at the 1000 ug/ml dose, and no positive results were seen at the 4000 µg/ml dose, there was no dose-response relationship, and the test substance is not clastogenic.
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- The test substance Therminol 55 is not clastogenic either in the presence or absence of metabolic activation.
- Executive summary:
This study examined the potential for the test substance Therminol 55 to be clastogenic. Chinese hamster ovary (CHO) cells were exposed to concentrations of 50, 100, 500, 1000, 4000 ug/ml of test substance for 24 hrs. After the exposure period, the cells were fixed, and examined under a microscope for cytotoxicity and chromosomal aberrations. The only positive result in exposure groups was at the 1000 ug/ml dose. Since a positive result was not seen at the 4000 ug/ml dose level, the test substance was considered not clastogenic. Theses findings were confirmed by an independent lab. No cytotoxicity was seen at any dose level.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 100, 250, 500, 750, 1000 ug/ml
- Vehicle / solvent:
- acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: benzo(a)pyrene, ethylmethylsulfonate
- Details on test system and experimental conditions:
0.5 x 10^6 CHO cells/plates were seeded in culture flasks with growth medium 18-24 hrs before the start of the test. On the day of the test, medium was changed to Ham's F12 medium without serum. Test substance was then added. Plates were incubated for 3 hrs at 37.5 +/- 2 degree. The cells were washed, and counted. Three aliquots of 200 cells were plated, then incubated for 6-9 days, and then counted for cloning efficiency. 10^6 cells per sample were supplemented with 10% newborn calf serum. Cells were subcultured every 2-3 days for 7-9 days. 5 plates of 2 x 10^5 cells were made to examine for mutagenicity.- Statistics:
- Snee, RD, and Irr, JD (1981). Design of a statistical method for the analysis of mutagenesis a the hypoanthine guanine phosphoribosyl transferase locus of cultured Chinese hamster ovary cells. Mutat. Res., 85: 77-93.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A statistically significant increase in mutations was seen at the 750 ug/ml without S9 dose level in the confirmation experiment. The mean mutant frequency was less than half the maximum acceptable background level at this dose, so this result was not considered biologically significant.
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not mutagenic in CHO cells in either the presence or absence of metabolic activation. - Executive summary:
This study examined the potential of the test substance to be mutagenic in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0, 100, 250, 500, 750, and 1000 ug/ml of test substance in both the presence and absence of metabolic activation. Benzo(a)pyrene and ethylmethylsulfonate were used as positive control substances. No biologically significant results were seen in any treatment groups. The test substance is not mutagenic in either the presence or absence of metabolic activation.
Referenceopen allclose all
Results of Cytogenicity Assay in CHO Cells
Dose per ml |
S9 |
% aberrant cells including gaps |
% aberrant cells including gaps |
Cell exchanges |
7 hrs |
||||
Solvent |
No |
3.50 |
1.50 |
0.00 |
80 nl |
No |
5.00 |
2.00 |
0.50 |
Solvent |
Yes |
15.00 |
5.00 |
1.00 |
80 nl |
Yes |
10.00 |
3.50 |
0.00 |
24 hrs |
||||
Control |
No |
7.00 |
2.50 |
1.50 |
Solvent |
No |
4.00 |
3.00 |
1.00 |
EMS 0.72 mg |
No |
17.00 |
16.00 |
11.00 |
5.0 nl/ml |
No |
2.50 |
2.00 |
0.00 |
30 nl/ml |
No |
2.50 |
2.00 |
0.50 |
80 nl/ml |
No |
4.50 |
3.50 |
0.50 |
Control |
Yes |
9.50 |
4.50 |
1.00 |
Solvent |
Yes |
3.00 |
3.00 |
0.50 |
CPA 4.2 ug |
Yes |
60.50 |
58.50 |
33.00 |
5.0 nl |
Yes |
5.50 |
2.00 |
1.50 |
30 nl |
Yes |
4.50 |
2.50 |
1.00 |
80 nl |
Yes |
4.00 |
3.00 |
0.00 |
30 hrs |
||||
Solvent |
No |
6.00 |
3.50 |
1.00 |
60.0 nl |
No |
4.50 |
0.00 |
0.00 |
Solvent |
Yes |
8.50 |
5.00 |
0.50 |
80.0 nl |
Yes |
2.00 |
0.00 |
0.00 |
Results for Experiment I (Mean Revertants/plate (SD)) ¿ Without S9
Concentration (ug/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Water |
31 (4) |
152 (3) |
15 (4) |
20 (6) |
25 (4) |
Acetone |
42 (2) |
165 (5) |
13 (6) |
11 (2) |
26 (2) |
8 |
38 (8) |
154 (26) |
15 (6) |
11 (4) |
24 (1) |
40 |
36 (2) |
140 (26) |
12 (9) |
11 (1) |
30 (4) |
200 |
39 (6) |
162 (6) |
9 (1) |
17 (4) |
25 (4) |
1000 |
31 (2) |
149 (15) |
14 (4) |
10 (1) |
22 (1) |
5000 |
36 (2) |
136 (6) |
10 (3) |
6 (2) |
25 (3) |
Nitrofluorene 2.5 |
101 (12) |
- |
477 (12) |
- |
62 (12) |
Sodium Azide 2.5 |
- |
651 (36) |
- |
- |
- |
Aminoanthracene 10 |
- |
135 (7) |
- |
- |
- |
Aminoacridine 25 |
- |
- |
- |
67 (19) |
- |
Results for Experiment I (Mean Revertants/plate (SD)) ¿ With S9
Concentration (ug/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Water |
54 (9) |
126 (34) |
13 (2) |
17 (1) |
34 (8) |
Acetone |
54 (3) |
155 (25) |
14 (3) |
18 (1) |
38 (6) |
8 |
50 (3) |
160 (6) |
17 (8) |
22 (6) |
47 (6) |
40 |
45 (2) |
164 (24) |
19 (4) |
23 (6) |
41 (13) |
200 |
46 (3) |
140 (29) |
11 (3) |
23 (4) |
39 (4) |
1000 |
57 (1) |
140 (11) |
20 (3) |
24 (4) |
32 (10) |
5000 |
57 (3) |
162 (8) |
14 (5) |
22 (2) |
38 (3) |
Nitrofluorene 2.5 |
- |
- |
- |
- |
- |
Sodium Azide 2.5 |
- |
- |
- |
- |
- |
Aminoanthracene 10 |
- |
649 (51) |
- |
- |
- |
Aminoacridine 25 |
- |
- |
- |
- |
- |
Results for Experiment II (Mean Revertants/plate (SD)) ¿ Without S9
Concentration (ug/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Water |
35 (4) |
109 (6) |
10 (1) |
13 (3) |
27 (3) |
Acetone |
33 (1) |
104 (7) |
14 (5) |
15 (1) |
27 (6) |
8 |
37 (4) |
113 (12) |
9 (2) |
15 (1) |
36 (8) |
40 |
37 (1) |
106 (4) |
11 (2) |
12 (1) |
28 (2) |
200 |
40 (9) |
117 (8) |
12 (6) |
14 (6) |
31 (3) |
1000 |
44 (2) |
107 (7) |
11 (5) |
11 (3) |
37 (5) |
5000 |
33 (4) |
108 (5) |
17 (4) |
16 (3) |
22 (4) |
Nitrofluorene 2.5 |
90 (11) |
- |
- |
- |
84 (13) |
Sodium Azide 2.5 |
- |
550 (57) |
440 (24) |
- |
- |
Aminoanthracene 10 |
- |
122 (4) |
- |
- |
- |
Aminoacridine 25 |
- |
- |
- |
66 (17) |
- |
Results for Experiment II (Mean Revertants/plate (SD)) ¿ With S9
Concentration (ug/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
Water |
51 (8) |
114 (6) |
15 (5) |
21 (3) |
38 (10) |
Acetone |
47 (12) |
124 (10) |
13 (3) |
23 (2) |
39 (7) |
8 |
40 (4) |
112 (11) |
13 (4) |
15 (3) |
42 (4) |
40 |
33 (4) |
112 (10) |
18 (7) |
16 (2) |
43 (2) |
200 |
43 (2) |
117 (13) |
14 (3) |
16 (4) |
46 (5) |
1000 |
39 (3) |
118 (5) |
9 (3) |
14 (3) |
42 (5) |
5000 |
44 (5) |
103 (4) |
15 (4) |
15 (2) |
40 (4) |
Nitrofluorene 2.5 |
- |
- |
- |
- |
- |
Sodium Azide 2.5 |
- |
- |
- |
- |
- |
Aminoanthracene 10 |
- |
437 (48) |
- |
- |
- |
Aminoacridine 25 |
- |
- |
- |
- |
- |
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 |
Results of Cytogenicity Assay in CHO Cells at 24 hrs- With Metabolic Activation
Dose |
No. Aberrations |
No. Cells with Aberrations |
% Aberrant Cells |
Aberrations/Cell |
% Mean Mitotic Index |
Acetone |
3 |
1 |
0.5 |
0.015 |
3.7 |
500 ug/ml |
6 |
4 |
2.0 |
0.025 |
4.2 |
1000 ug/ml |
11 |
9 |
4.5 |
0.055 |
5.1 |
4000 ug/ml |
4 |
4 |
2.0 |
0.020 |
5.9 |
Cyclophosphamide |
1319 |
199 |
99.5 |
6.595 |
1.6 |
Results of Cytogenicity Assay in CHO Cells at 24 hrs- Without Metabolic Activation
Dose |
No. Aberrations |
No. Cells with Aberrations |
% Aberrant Cells |
Aberrations/Cell |
% Mean Mitotic Index |
Acetone |
6 |
6 |
2.5 |
0.030 |
6.8 |
500 ug/ml |
8 |
8 |
4.0 |
0.040 |
4.6 |
1000 ug/ml |
4 |
4 |
2.0 |
0.020 |
7.3 |
4000 ug/ml |
2 |
2 |
1.0 |
0.010 |
6.7 |
MMS |
372 |
151 |
75.5 |
1.860 |
6.1 |
Results of Mutagenicity Assay in CHO Cells - Initial Experiment
Dose |
Cytotoxicity |
Mean Mutant Frequency x 10-6 |
Without S9 |
||
Acetone |
- |
12.0 |
250 ug/ml |
1.29 |
8.0 |
500 ug/ml |
0.96 |
5.6 |
1000 ug/ml |
1.03 |
9.7 |
EMS 200 ug/ml |
- |
177.9 |
1 % S9 |
||
Acetone |
- |
4.6 |
250 ug/ml |
1.02 |
9.9 |
500 ug/ml |
1.10 |
7.4 |
1000 ug/ml |
0.90 |
7.4 |
B(a)P 1ug/ml |
- |
201.6 |
2 % S9 |
||
Acetone |
- |
8.8 |
250 ug/ml |
0.99 |
18.3 |
500 ug/ml |
0.61 |
28.1 |
1000 ug/ml |
0.96 |
2.9 |
B(a)P 1ug/ml |
- |
296.2 |
5 % S9 |
||
Acetone |
- |
26.1 |
250 ug/ml |
1.18 |
17.5 |
500 ug/ml |
1.20 |
14.5 |
1000 ug/ml |
1.05 |
7.9 |
B(a)P 1ug/ml |
- |
185.5 |
10 % S9 |
||
Acetone |
- |
1.7 |
250 ug/ml |
1.35 |
11.1 |
500 ug/ml |
1.27 |
11.8 |
1000 ug/ml |
1.32 |
12.2 |
B(a)P 1ug/ml |
- |
80.6 |
Results of Mutagenicity Assay in CHO Cells - Confirmatory Experiment
Dose |
Cytotoxicity |
Mean Mutant Frequency x 10-6 |
Without S9 |
||
Acetone |
- |
2.4 |
100 ug/ml |
1.04 |
3.3 |
250 ug/ml |
0.95 |
0.5 |
500 ug/ml |
0.98 |
2.3 |
750 ug/ml |
1.22 |
9.0 |
1000 ug/ml |
1.04 |
1.9 |
EMS 200 ug/ml |
- |
212.2 |
5% S9 |
||
Acetone |
- |
3.1 |
100 ug/ml |
1.00 |
0.5 |
250 ug/ml |
1.14 |
2.3 |
500 ug/ml |
1.21 |
2.6 |
750 ug/ml |
1.22 |
1.4 |
1000 ug/ml |
1.32 |
2.8 |
B(a)P 1ug/ml |
- |
273.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
In a series of reliable mutagenicity studies, HAB was determined to be not mutagenic in any of the in vitro studies conducted. In vivo data were not available (scientifically not justified because acute dermal studies indicate no adverse effects up to and surpassing 2000 mg/kg bw).
Justification for selection of genetic toxicity endpoint
Experimental results. In vivo genetic toxicity data not available
(scientifically not justified).
Justification for classification or non-classification
In a series of reliable mutagenicity studies, HAB was determined to be not mutagenic in any of thein vitrostudies conducted.
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