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EC number: 242-016-2 | CAS number: 18127-01-0
- 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
Ames, OECD 471, GLP study: Negative.
Mouse Lymphoma Assay, OECD 490, GLP study: Negative
In vitro Micronucleus Test, OECD 487, GLP study: Negative.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine for Salmonella.
Tryptophan for E.Coli - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Based on the results of the first mutation experiment, BOURGEONAL was tested up to concentrations of 512 and 5000 μg/plate in the absence and presence of 10% (v/v) S9-mix in the Salmonella typhimurium and Escherichia coli strain, respectively.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191; 2-aminoanthracene
- Details on test system and experimental conditions:
- According to OECD 471
- Rationale for test conditions:
- According to OECD 471
- Evaluation criteria:
- According to OECD 471
- Statistics:
- According to OECD 471
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion, based on the results of this study it is concluded that BOURGEONAL is not
mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli
reverse mutation assay. - Executive summary:
The objective of this study was to determine the potential of BOURGEONAL and/or its
metabolites to induce reverse mutations at the histidine locus in several strains of Salmonella
typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan
locus of Escherichia coli (E. coli) strain WP2uvrA in the presence or absence of an exogenous
mammalian metabolic activation system (S9).
The study procedures described in this report were based on the most recent OECD, EC and
METI guidelines.
Batch SC00021197 of BOURGEONAL was a pale yellow liquid with a purity of 97.2%. The
test item was dissolved in dimethyl sulfoxide.
In the first mutation assay, the test item was tested up to concentrations of 5000 μg/plate in
the absence and presence of 5% (v/v) S9-mix. The test item precipitated on the plates at this
dose level. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of
the bacterial background lawn and/or the presence of microcolonies, was observed in all tester
strains in the absence and presence of S9-mix.
In the second mutation assay, the test item was tested up to concentrations of 512 and
5000 μg/plate in the absence and presence of 10% (v/v) S9-mix in the Salmonella
typhimurium and Escherichia coli strain, respectively. The test item precipitated on the plates
at the dose level of 5000 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of
revertants, reduction of the bacterial background lawn and or the presence of microcolonies,
was observed in all tester strains in the absence and presence of S9-mix. Except for tester
strain WP2uvrA in the presence of S9-mix where no toxicity was observed.
BOURGEONAL did not induce a significant dose-related increase in the number of revertant
(His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in
the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and
presence of S9-metabolic activation. These results were confirmed in an independently
repeated experiment.
In this study, acceptable responses were obtained for the negative and strain-specific positive
control items indicating that the test conditions were adequate and that the metabolic
activation system functioned properly.
In conclusion, based on the results of this study it is concluded that BOURGEONAL is not
mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli
reverse mutation assay.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes:
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- In the first cytogenetic assay, BOURGEONAL was tested up to 51 µg/mL and 60 µg/mL for a 3 hours exposure time with a 27 hours harvest time in the absence and presence of
S9-fraction, respectively. Appropriate toxicity was reached at these dose levels.
In the second cytogenetic assay, BOURGEONAL was tested up to 50 µg/mL for a 24 hours exposure time with a 24 hours harvest time in the absence of S9-mix. Appropriate toxicity was reached at this dose level. - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- other: Colchicine
- Details on test system and experimental conditions:
- According to OECD guideline
- Rationale for test conditions:
- According to OECD guideline
- Evaluation criteria:
- According to OECD guideline
- Statistics:
- According to OECD guideline
- Key result
- Species / strain:
- lymphocytes: lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion, this test is valid and BOURGEONAL is not clastogenic or aneugenic in human lymphocytes under the experimental conditions described in this report.
- Executive summary:
The objective of this study was to evaluate BOURGEONAL for its ability to induce micronuclei in cultured human lymphocytes, either in the presence or absence of a metabolic activation system (S9-mix). The possible clastogenicity and aneugenicity of BOURGEONAL was tested in two independent experiments.
The study procedures described in this report are in compliance with the most recent OECD guideline.
BOURGEONAL was a pale yellow liquid.The vehicle of the test item was dimethyl sulfoxide.
In the first cytogenetic assay, BOURGEONAL was tested up to 51 µg/mL and 60 µg/mL for a 3 hours exposure time with a 27 hours harvest time in the absence and presence of
S9-fraction, respectively. Appropriate toxicity was reached at these dose levels.In the second cytogenetic assay, BOURGEONAL was tested up to 50 µg/mL for a 24 hours exposure time with a 24 hours harvest time in the absence of S9-mix. Appropriate toxicity was reached at this dose level.
The number of mono- and binucleated cells with micronuclei found in the solvent control cultures was within the 95% control limits of the distribution of the historical negative control database. The positive control chemicals, mitomycin C and cyclophosphamide both produced a statistically significant increase in the number of binucleated cells with micronuclei. The positive control chemical colchicine produced a statistically significant increase in the number of mononucleated cells with micronuclei. In addition, the number of mono- and binucleated cells with micronuclei found in the positive control cultures was within the 95% control limits of the distribution of the historical positive control database. It was therefore concluded that the test conditions were adequate and that the metabolic activation system
(S9-mix) functioned properly.BOURGEONAL did not induce a statistically significant and biologically relevant increase in the number of mono- and binucleated cells with micronuclei in the absence and presence of S9-mix, in either of the two experiments.
In conclusion, this test is valid and BOURGEONAL is not clastogenic or aneugenic in human lymphocytes under the experimental conditions described in this report.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- thymidine kinase (TK) locus in L5178Y
mouse lymphoma cells - Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- First Mutagenicity Test
Based on the results of the dose-range finding test, the following dose-ranges were selected
for the first mutagenicity test:
Without S9-mix: 0.31, 0.63, 1.25, 2.5, 5, 10, 15, 20, 25, 30 and 35 μg/ml exposure medium.
With S9-mix: 1.88, 3.75, 7.5, 15, 30, 40, 45, 50, 55, 60 and 65 μg/ml exposure medium.
Evaluation of toxicity
In the absence of S9-mix, the dose levels of 0.31 to 20 μg/ml showed no cytotoxicity.
Therefore, the dose levels of 0.63, 5 and 10 μg/ml were not regarded relevant for mutation
frequency measurement.
In the presence of S9-mix, the dose levels of 1.88 to 45 μg/ml showed no cytotoxicity.
Therefore, the dose levels of 3.75, 7.5 and 30 μg/ml were not regarded relevant for mutation
frequency measurement.
The dose levels selected to measure mutation frequencies at the TK-locus were:
Without S9-mix: 0.31, 1.25, 2.5, 15, 20, 25, 30 and 35 μg/ml exposure medium.
With S9-mix: 1.88, 15, 40, 45, 50, 55, 60 and 65 μg/ml exposure medium.
Second Mutagenicity Test
To obtain more information about the possible mutagenicity of BOURGEONAL, a second
mutation experiment was performed in the absence of S9-mix with a 24 hour treatment
period.
Based on the results of the additional dose-range finding test, the following dose levels were
selected for mutagenicity testing 0.63, 1.25, 2.5, 5, 10, 15, 17.5, 20, 22.5, 25 and 30 μg/ml
exposure medium.
Evaluation of toxicity
The dose levels of 22.5 to 30 μg/ml were not used for mutation frequency measurement, since
these dose levels were too toxic for further testing.
The dose levels selected to measure mutation frequencies at the TK-locus were: 0.63, 1.25,
2.5, 5, 10, 15, 17.5 and 20 μg/ml exposure medium. - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Accoridng to OECD guidelines
- Rationale for test conditions:
- Accoridng to OECD guidelines
- Evaluation criteria:
- Accoridng to OECD guidelines
- Statistics:
- Accoridng to OECD guidelines
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion, BOURGEONAL is not mutagenic in the mouse lymphoma L5178Y test
system under the experimental conditions described in this report. - Executive summary:
The objective of this study was to evaluate the mutagenic potential of BOURGEONAL by
testing its ability to induce forward mutations at the thymidine kinase (TK) locus in L5178Y
mouse lymphoma cells, either in the absence or presence of a metabolic system (S9-mix).
The TK mutational system detects base pair mutations, frame shift mutations and small
deletions.
The test was performed in the absence of S9-mix with 3 and 24 hour treatment periods and in
the presence of S9-mix with a 3 hour treatment period.
The study procedures described in this report were based on the most recent OECD guideline.
Batch SC00021197 of BOURGEONAL was a pale yellow liquid. The test item was
dissolved in dimethyl sulfoxide.
In the first experiment, BOURGEONAL was tested up to concentrations of 35 μg/ml and
65 μg/ml in the absence and presence S9-mix, respectively. The incubation time was 3 hours.
Relative total growth (RTG) was reduced to 16% and 3% in the absence and presence of
S9-mix, respectively. The test item did not precipitate in the culture medium up to the dose
level of 65 μg/ml.
In the second experiment, BOURGEONAL was tested up to concentrations of 20 μg/ml in the
absence of S9-mix. The incubation time was 24 hours. The RTG was reduced to 10%. The
test item did not precipitate in the culture medium up to the dose level of 20 μg/ml.
The mutation frequency found in the solvent control cultures was within the acceptability
criteria of this assay
Positive control chemicals, methyl methanesulfonate and cyclophosphamide, both produced
significant increases in the mutation frequency. In addition, the mutation frequency found in
the positive control cultures was within the 95% control limits of the distribution of the
historical positive control database. It was therefore concluded that the test conditions were
adequate and that the metabolic activation system (S9-mix) functioned properly.
In the absence of S9-mix, BOURGEONAL did not induce a significant increase in the
mutation frequency in the first experiment. This result was confirmed in an independent
experiment with modification in the duration of treatment.
In the presence of S9-mix, BOURGEONAL did not induce a significant increase in the
mutation frequency.
In conclusion, BOURGEONAL is not mutagenic in the mouse lymphoma L5178Y test
system under the experimental conditions described in this report.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No in vivo data was available and based on the in vitro data set available, no need for in vivo testing was deemed necessary.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the data available on Bourgeonal, no classification for genotoxicity is necessary according to the (EC) No 1272/2008 Regulation (CLP).
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