Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 243-797-2 | CAS number: 20407-84-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
negative, in vitro bacterial reverse mutation (with and without S-9 activation), OECD TG 471, 2015
Link to relevant study records
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Guideline stipulated by the Japanese Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry and Ministry of the Environment (revised March 31st, 2011)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected March 2013; signature: May 2013
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal enzymes (S9 homogenate)
- Test concentrations with justification for top dose:
- Dose range finding study: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 ug/plate (Strains: TA100 and WP2uvrA)
Experiment 1: 0.17, 0.54, 1.7, 5.4, 17, 52 ug/plate (Strains: TA1535, TA1537, TA98 and TA100)
Experiment 2: 0.17, 0.54, 1.7, 5.4, 17, 52 and 164 ug/plate (Strains: TA1535, TA1537, TA98 and TA100) and; 5.4, 17, 52, 164, 512, 1600 and 5000 ug/plate (Strains: WP2uvrA) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulphoxide (DMSO)
- Justification for choice of solvent/vehicle: A solubility test was performed. The test substance could not be dissolved in water. The test substance was soluble in DMSO. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- 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:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: the plates were inverted and incubated in the dark at 37.0 ± 1.0 °C for 48 ± 4 h. After this period revertant colonies (histidine independent (His+) for Salmonella typhimurium bacteria and tryptophan independent (Trp+) for Escherichia coli were counted. The revertant colonies were counted automatically with a Colony Counter. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually and evidence of test article precipitate on the plates was recorded. The condition of the bacterial background lawn was evaluated, both macroscopically and microscopically by using a dissecting microscope.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (bacterial background lawn) and reduction in the number of revertants
OTHER:
Dose range finding test on TA100 and WP2urvA with and without 5% (v/v) S9-mix; First mutation assay on TA1535, TA1537 and TA98 with and without 5% (v/v) S9-mix. To obtain more information about the possible mutagenicity of the test substance, a second mutation experiment was performed on all strains, in the absence of S9-mix and in the presence of 10% (v/v) S9-mix. Based on the results of the first mutation assay, the test substance was tested up to the dose level of 164 μg/plate in strains TA1535, TA1537, TA98 and TA100. Whereas WP2uvrA was tested up to 5000 μg/plate. - Evaluation criteria:
- See 'Any other information on materials and methods' for details on evaluation of the assay and positive criteria.
- Statistics:
- No formal hypothesis testing was done. See 'Any other information on materials and methods' for details on the acceptability and evaluation criteria of the assay.
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- In tester strain TA100, fluctuation in the number of revertant colonies below the laboratory historical control data range was observed at the mid doses of 492 µg/plate and 878 µg/plate. This reduction was not considered to be caused by toxicity.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Dose range finding test: Precipitation of the test substance on the plates was observed at the start of the incubation period at concentrations of 1600 and 5000 µg/plate. No precipitate was observed at the end of the incubation period. Mutation experiments 1 and 2: Precipitation of the test substance on the plates was not observed at the start or at the end of the incubation.
RANGE-FINDING/SCREENING STUDIES:
Test substance was tested in the tester strains TA100 and WP2uvrA with concentrations of 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate in the absence and presence of S9-mix. Based on the results of the dose range finding test, the following dose range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 52, 164, 512, 1600 and 5000 μg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA:
Historical control data from experiments was presented within the study report.
1. The negative control values were within the laboratory historical control data ranges, except for the response of TA100 in the absence of S9-mix (dose range finding) and TA1537 in the presence of S9-mix (second experiment). The value of 64 in tester strain TA100 was just below the limit of the range (69) and the value of 28 in tester strain TA1537 was above the limit of the range (21) of the historic control range. The mean plate counts were just outside the limit of the ranges, therefore this deviation in the mean plate count of the solvent control had no effect on the results of the study.
2. The positive control substance of tester strain TA100 (second experiment, absence of S9-mix) showed a response (mean plate count) which was not within the laboratory historical range. The value (1436) was above the limit of the range (1394). The purpose of the positive control is as a reference for the test system, where a positive response is required to check if the test system functions correctly. Since the value was more than 3 times greater than the concurrent solvent control values, this deviation in the mean plate count of the positive control had no effect on the results of the study.
The integrity of the study was not considered to be impacted by the above minor deviations from historic control values. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results:
negative
Under the conditions of this study the test substance is not considered to be mutagenic. Negative and strain specific positive control values were in general within laboratory historical control data ranges indicating that the test conditions were adequate. - Executive summary:
The study was performed to OECD TG 471, EU Method B.13/14, EPA OPPTS 870.5100 and the Japan Guidelines for Screening Mutagenicity of Chemicals in accordance with GLP; to evaluate the mutagenic activity of the test substance in the Salmonella typhimurium and the Escherichia coli in a reverse mutation assay (with independent repeat). In the dose range finding test, the test substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. In tester strain TA100, toxicity was observed at dose levels of 17 μg/plate and above in the absence of S9-mix and at 52 μg/plate and above in the presence of S9-mix. In tester strain WP2uvrA, toxicity was observed at dose levels of 512 μg/plate and above in the absence and presence of S9-mix. Results of this dose range finding test were reported as part of the first mutation assay. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay at a concentration range of 0.17 to 52 µg/plate in the absence of S9-mix and at 0.54 to 164 µg/plate in the presence of 5% (v/v) S9-mix in the tester strains TA1535, TA1537 and TA98. Toxicity was observed in all four tester strains in the absence and presence of S9-mix. In a follow-up experiment of the assay with additional parameters, the test substance was tested at a concentration range of 0.17 to 52 µg/plate in the absence of S9-mix and at a concentration range of 0.54 to 164 µg/plate in the presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98 and TA100 and at 5.4 to 5000 µg/plate in tester strain WP2uvrA in the absence and presence of 10% (v/v) S9-mix. Toxicity was observed in all tester strains in the absence and presence of S9-mix. The test substance 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 the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment. The negative control values were within the laboratory historical control data ranges, except for TA100 in the absence of S9-mix (dose range finding) and TA1537 in the presence of S9-mix (second experiment). However, the validity of the test was considered to be not affected. The strain-specific positive control values were at least three times the concurrent vehicle control group mean indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the conditions of this study it is concluded that that the test substance was not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reference
Table 1 Dose range finding test: Mutagenic response of test substance in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with one strain of Salmonella typhimurium and one Escherichia coli strain |
|||||||
|
TA100 |
TA100 |
||||||
Without S9-mix |
|
|
|
|
|
|
|
|
Positive control |
750 |
± |
15 |
|
1177 |
± |
89 |
|
Solvent control |
64 |
± |
5 |
|
28 |
± |
4 |
|
1.7 |
80 |
± |
9 |
|
28 |
± |
5 |
|
5.4 |
75 |
± |
13 |
n |
27 |
± |
4 |
|
17 |
44 |
± |
2 |
m |
27 |
± |
3 |
|
52 |
|
|
|
e MC |
25 |
± |
5 |
|
164 |
|
|
|
e MC |
15 |
± |
4 |
n |
512 |
|
|
|
a |
14 |
± |
6 |
s |
1600 |
|
|
|
a NP |
9 |
± |
3 |
m |
5000 |
|
|
|
a NP |
3 |
± |
2 |
m NP |
With S9-mix1 |
|
|
|
|
|
|
|
|
Positive control |
1161 |
± |
144 |
|
244 |
± |
20 |
|
Solvent control |
83 |
± |
10 |
|
37 |
± |
9 |
|
1.7 |
78 |
± |
10 |
|
33 |
± |
8 |
|
5.4 |
71 |
± |
13 |
|
28 |
± |
10 |
|
17 |
88 |
± |
12 |
n |
34 |
± |
1 |
|
52 |
67 |
± |
9 |
s |
25 |
± |
4 |
|
164 |
|
|
|
e MC |
30 |
± |
7 |
|
512 |
|
|
|
a |
11 |
± |
4 |
|
1600 |
|
|
|
a |
9 |
± |
2 |
n |
5000 |
|
|
|
a NP |
2 |
± |
1 |
s NP |
1: Plate incorporation assay (5% S9)
MC: Microcolonies
NP: No precipitate
a: Bacterial background lawn absent
e: Bacterial background lawn extremely reduced
m: Bacterial background lawn moderately reduced
n: Normal bacterial background lawn
s: Bacterial background lawn slightly reduced
Table 2 Experiment 1: Mutagenic response of test substance in the Salmonella typhimurium reverse mutation assay
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium |
|||||||||||||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
||||||||||||
Without S9-mix |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Positive control |
889 |
± |
53 |
|
4 |
± |
4 |
|
1162 |
± |
60 |
|
968 |
± |
26 |
|
Solvent control |
18 |
± |
2 |
|
5 |
± |
6 |
|
19 |
± |
4 |
|
93 |
± |
20 |
|
0.17 |
25 |
± |
11 |
|
5 |
± |
3 |
|
19 |
± |
1 |
|
93 |
± |
4 |
|
0.54 |
17 |
± |
5 |
|
8 |
± |
3 |
|
13 |
± |
4 |
|
96 |
± |
5 |
|
1.7 |
18 |
± |
3 |
|
9 |
± |
8 |
|
18 |
± |
5 |
|
94 |
± |
1 |
|
5.4 |
17 |
± |
6 |
n |
7 |
± |
3 |
n |
17 |
± |
6 |
n |
95 |
± |
3 |
n |
17 |
9 |
± |
1 |
m |
5 |
± |
1 |
m |
15 |
± |
1 |
s |
94 |
± |
10 |
m |
52 |
|
|
|
e NP MC |
|
|
|
a NP |
|
|
|
e NP MC |
- |
|
|
a NP |
With S9-mix1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Positive control |
257 |
± |
14 |
|
486 |
± |
78 |
|
1089 |
± |
66 |
|
1752 |
± |
370 |
|
Solvent control |
13 |
± |
7 |
|
9 |
± |
2 |
|
23 |
± |
1 |
|
93 |
± |
5 |
|
0.54 |
12 |
± |
5 |
|
11 |
± |
5 |
|
32 |
± |
4 |
|
120 |
± |
8 |
|
1.7 |
16 |
± |
5 |
|
12 |
± |
2 |
|
28 |
± |
6 |
|
92 |
± |
9 |
|
5.4 |
14 |
± |
6 |
|
10 |
± |
4 |
|
32 |
± |
9 |
|
89 |
± |
8 |
|
17 |
13 |
± |
3 |
n |
13 |
± |
12 |
n |
26 |
± |
7 |
|
97 |
± |
12 |
n |
52 |
6 |
± |
2 |
m |
|
|
|
e |
20 |
± |
4 |
n |
73 |
± |
18 |
m |
164 |
|
|
|
a NP |
|
|
|
a NP |
|
|
|
e NP MC |
- |
|
|
a NP |
1: Plate incorporation assay (5% S9)
MC: Microcolonies
NP: No precipitate
a: Bacterial background lawn absent
e: Bacterial background lawn extremely reduced
m: Bacterial background lawn moderately reduced
n: Normal bacterial background lawn
s: Bacterial background lawn slightly reduced
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key data : OECD TG 471, 2015 : The study was performed to OECD TG 471, EU Method B.13/14, EPA OPPTS 870.5100 and the Japan Guidelines for Screening Mutagenicity of Chemicals in accordance with GLP; to evaluate the mutagenic activity of the test substance in the Salmonella typhimurium and the Escherichia coli in a reverse mutation assay (with independent repeat). In the dose range finding test, the test substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. In tester strain TA100, toxicity was observed at dose levels of 17 μg/plate and above in the absence of S9-mix and at 52 μg/plate and above in the presence of S9-mix. In tester strain WP2uvrA, toxicity was observed at dose levels of 512 μg/plate and above in the absence and presence of S9-mix. Results of this dose range finding test were reported as part of the first mutation assay. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay at a concentration range of 0.17 to 52 µg/plate in the absence of S9-mix and at 0.54 to 164 µg/plate in the presence of 5% (v/v) S9-mix in the tester strains TA1535, TA1537 and TA98. Toxicity was observed in all four tester strains in the absence and presence of S9-mix. In a follow-up experiment of the assay with additional parameters, the test substance was tested at a concentration range of 0.17 to 52 µg/plate in the absence of S9-mix and at a concentration range of 0.54 to 164 µg/plate in the presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98 and TA100 and at 5.4 to 5000 µg/plate in tester strain WP2uvrA in the absence and presence of 10% (v/v) S9-mix. Toxicity was observed in all tester strains in the absence and presence of S9-mix. The test substance 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 the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment. The negative control values were within the laboratory historical control data ranges, except for TA100 in the absence of S9-mix (dose range finding) and TA1537 in the presence of S9-mix (second experiment). However, the validity of the test was considered to be not affected. The strain-specific positive control values were at least three times the concurrent vehicle control group mean indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the conditions of this study it is concluded that that the test substance was not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Justification for classification or non-classification
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for mutagenicity
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)