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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-056-5 | CAS number: 14205-39-1
- 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:
- 22 October 1999 - 29 November 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
- Details on test material:
- Expiry date: 21 May 2000
Batch: 624
Constituent 1
- Specific details on test material used for the study:
- Stored in the dark at ambient temperature.
Method
- Target gene:
- The purpose of this study was to establish the potential of LZ937 to induce gene mutations in Salmonella typhimurium and Eschericha coli.
The specific damage caused by a mutagen may not be detectable using a particular strain of bacteria. This is because the DNA site coding
for a feature selected in the test system may not be mutated by the type of agent under examination. It is necessary, therefore, to use a variety
of bacterial strains in order to test for a broad range of chemical mutagens. At the present time, available data suggest that the use of the 5 strains
used in this project permits the detection of a wide spectrum of mutagens.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Mutations in the histidine operon, his G 46.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- Mutations in the histidine operon, his C 3076
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Mutations in the histidine operon, his D 3052.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Mutations in the histidine operon, his G 46.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Strain contains an ochre mutation in the trpE locus and can be mutated to tryptophan independence either by a base-pair reversion of an A-T base-pair in the trpE locus or, more likely, by a base-pair substitution within a number of transfer RNA loci elsewhere in the chromosome.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced S9 enzymes (the supernatant of the post-mitochondial 9000 g fraction) were prepared from the livers of adult, male Fischer rats, as described by Ames eta/ (1975).
- Test concentrations with justification for top dose:
- 17 ug/plate, 50 ug/plate, 167 ug/plate, 500 ug/plate, 1667 ug/plate and 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulphoxide
Controls
- Untreated negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene (2-AAN)
- Details on test system and experimental conditions:
- Test Solution:
Dimethylsulphoxide (DMSO) was used to dissolve and dilute LZ937.
Vehicle Control:
Dimethylsulphoxide (DMSO) was used as the vehicle control.
Inducer:
The inducer was the polychlorinated biphenyl mixture, Aroclor 1254.
Agar Plates:
The Vogel-Bonner Medium E agar plates with 2% glucose used in the Ames test were prepared in-house using purified agar.
Animals:
The animals used to prepare the activation system were male Fischer 344 rats.
Preparation of Bacteria:
Samples of each strain were grown by culturing for 16 h at 3]DC in nutrient broth (25 g Oxoid Nutrient Broth No.2 per litre). These cultures were kept for up to
2 days at +4 oc to allow relevant checks to be performed but fresh cultures were used for the experiments.
Preparation of the Assay Plates:
Diluted agar {0.6% Difco Bacto-agar, 0.6% NaCJ) was sterilised by autoclaving. L-histidine and biotin solutions, and L-tryptophan solutions were sterilised by
filtration. For use with the S. typhimurium strains, sterile 1.0 mM L-histidine.HCI/1.0 mM biotin solution was added, 5 ml per 1 00 ml of soft agar.
For E. coli WP2uvrA, 1.0 ml of 1.35 mM L-tryptophan was added per 100 ml agar. The agars {with additions) were thoroughly mixed prior to use and
maintained in a water bath at 45°C. - Evaluation criteria:
- Evaluation:
----------
A test was considered acceptable if for each strain:
i) the bacteria demonstrated their typical responses to crystal violet, ampicillin and u.v. light.
ii) at least 2 of the vehicle control plates were within the following ranges: TA 1535, 4-30; TA 1537, 1-20; TA 98, 10-60; TA 100, 60-200 and TA 1538, 5-35.
iii) on at least 2 of the positive control plates there were x 2 the mean vehicle control mutant numbers per plate, or in the case of TA 100, x 1.5 the mean
vehicle control mutant numbers per plate. If the mean colony count on the vehicle control plates was less than 10 then a value of 10 was assumed for
assessment purposes. In such cases a minimum count of 20 was required on at least 2 of the positive control plates.
iv) no toxicity or contamination was observed in at least 4 dose levels.
v) in cases where a mutagenic response was observed, that no more than one dose level was discarded before the dose which gave the highest significant mean colony number.
Where these criteria were met, a significant mutagenic response was recorded if there was:
i) for s. typhimurium strains TA 1535, TA 1537, and TA 98 and E.coli at least a doubling of the mean concurrent vehicle control values at some
concentration of the test substances and, for S. typhimurium strain TA 100, a 1.5-fold increase over the control value. If the mean colony count on the
vehicle control plates was less than 10 then a value of 10 was assumed for assessment purposes. In such cases a minimum count of 20 was required
before a significant mutagenic response was identified.
ii) a dose related response, although at high dose levels this relationship could be inverted because of, for example, (1) toxicity to the bacteria generally,
(2) specific toxicity to the mutants and (3) inhibition of foreign compound metabolising enzymes where mutagens require metabolic activation by the liver.
iii) a reproducible effect in independent tests. - Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- First mutation assay
- 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 examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- first mutation assay
- 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 examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- first mutation assay
- 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 examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- first mutation assay
- 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 examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- first mutation assay
- 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 examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- second mutation assay
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- no precipitation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- second mutation test
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- no precipitation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Confirmatory test 1 and 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- no precipitation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity Test:
------------
No toxicity to the bacteria was observed. No precipitation of the test material occurred.
Any other information on results incl. tables
Quality Control:
All strains were sensitive to crystal violet, whereas only the plasmid-containing strains, TA 98 and TA 100, were resistant to ampicillin. The strains were also tested for sensitivity
to u.v. light emitted over a period of 5-10 s from a lamp set at 254 nm. Increased sensitivity to u.v. light was demonstrated. These results are consistent with the known properties
of these bacteria.
Vehicle Control Groups:
The vehicle control values were generally within the normal ranges experienced in this laboratory and reported in the literature with these strains of S. typhimurium and E. coli,
(Ames eta/, 1975; Gatehouse eta/, 1994).
Positive Control Groups:
The results obtained in the positive control groups were within the normal ranges expected for each bacterial strain and activation condition.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that LZ937 was very weakly mutagenic with Escherichia coli only (in the presence of S9 mix) and not the Salmonella typhimurium strains
when tested in dimethylsulphoxide up to a predetermined maximum limit. - Executive summary:
A study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) was carried out in year 1999. Tested up to 5000 ug/plate without and with metabolic activation with five tester strains (TA 1535; TA 1537; TA 98; TA 100 and E coli WP2uvrA).
In the first mutation assay, no mutagenic activity was observed in any of the 5 bacterial strains, in either activation condition.
In the second mutation assay, mutagenic activity was observed with Escherichia coli only and in the presence of S9 mix from 500 microg per plate, after incubation for
20 min in the pre-incubation method of treatment. No response was observed with E. coli in the absence of S9 mix or with the Salmonella typhimurium strains
in the presence or absence of S9 mix.
No precipitation of the test material was observed.
It was concluded that LZ937 was very weakly mutagenic with Escherichia coli only (in the presence of 59 mix only) and not the Salmonella typhimurium strains,
when tested in dimethylsulphoxide up to a predetermined maximum limit.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies