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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-911-1 | CAS number: 61698-32-6
- 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
- Ames test: Negative (OECD 471, GLP, K, rel.1)
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:
- 05 Aug 2021 - April 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to the OECD TG 471 without any deviation affecting the reliability of the assay.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted July 21st, 1997 corrected 26.06.2020
- Deviations:
- yes
- Remarks:
- The deviations neither affected the overall interpretation of study findings nor compromised the integrity of the study. See 'additional information on methods' for details.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- S. typhimurium: Histidine gene | E. coli: Tryptophan gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- WP2 (uvr A ̄) (pKM101)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: MOLTOX (S9 Moltox-11101-5-4244 validated on 21.08.2020 – expiry date: 28.04.2022).
- method of preparation of S9 mix: prepared from Sprague Dawley rat liver homogenate,
- concentration or volume of S9 mix and S9 in the final culture medium: 10 % (v/v), 500 µL per plate
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): MOLTOX quality control and production certificate 28 Apr 2020 - Test concentrations with justification for top dose:
- Cytotoxicity assessment: 5000 μg /plate, 1500 μg /plate, 500 μg /plate, 150 μg /plate, 50 μg /plate | No cytotoxicity was observed to the highest dose, so the same doses were used for the main experiment.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: commonly used vehicle in which the test item was partially soluble (precipitate confirmed not to interfere with scoring) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other:
- Remarks:
- See Table 1 for details / strain. Solvent used to solubilize positive controls: Acetone, DMSO, NaCl 0.15 M
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration : triplicate
- Number of independent experiments: two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1-9 x10E9 bacteria/mL
- Test substance added in medium; in agar (plate incorporation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 30min (preincubation assays only)
- Exposure duration/duration of treatment: incubation at 37° over a 48-72-hour period
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: relative survival (RS)
- Any supplementary information relevant to cytotoxicity: In case bacteriostatic activity is detected, the highest concentration to be retained is that exhibiting a bacteriostatic activity of 75 % or less.
METHODS FOR MEASUREMENTS OF GENOTOXICITY: dose-related increase in the number of revertant colonies compared to the solvent control - Rationale for test conditions:
- Dose levels were selected based on the result of the bacteriostatic activity control test.
- Evaluation criteria:
- The result of the test is considered as negative if the revertant number is below three fold the number of spontaneous reversions, for TA 1535 and TA 1537 strains, and below two fold the number of spontaneous reversions for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101) strains without and with metabolic activation.
The result of the test is considered positive if a dose-response relationship between concentration and number of revertants is obtained in one, or several of the 5 strains, without and/or with metabolic activation. A mutagenic effect being taken into account for a given dilution of test item if the number of revertant colonies is at least two-fold that of spontaneous revertant colonies for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101), and three-fold for TA 1535 and TA 1537.
All results must be confirmed in an independent experiment. - Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: n.a.
- Data on osmolality: n.a.
- Possibility of evaporation from medium: n.a.
- Water solubility: n.a.
- Precipitation and time of the determination: none reported
- Definition of acceptable cells for analysis: n.a.
- Other confounding effects: none reported
RANGE-FINDING/SCREENING STUDIES (if applicable):
Results of the bacteriostatic activity control test showed no toxicity in presence of the test item. Therefore, the test item was tested at the following doses: 5 000, 1 500, 500, 150 and 50 µg/plate.
STUDY RESULTS
- Concurrent vehicle negative and positive control data:
- Signs of toxicity: none reported
- Individual plate counts: cf. Table of Results 'Attachments')
- Mean number of revertant colonies per plate and standard deviation: cf. Table of Results ('Attachments')
There is no evidence of any increase in the number of revertant colonies in the presence of the test item without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 strains and Escherichia coli WP2(uvr A¯)(pKM101) strain
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: cf. Table of Results 'Attachments')
- Negative (solvent/vehicle) historical control data: cf. Table of Results 'Attachments')
There is no difference between the number of spontaneous reversions, the number of reversions obtained for the positive controls (without and with metabolic activation), and the mean of corresponding experimental historical values obtained in the laboratory - Conclusions:
- Under the assay conditions, the test item did not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 strains and Escherichia coli WP2(uvr A ̄)(pKM101) strain without, or with metabolic activation, according to the OECD Guideline n° 471.
- Executive summary:
Suspensions obtained from CUREZOL 2PHZ-PW (the test item) have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2(uvr A ̄)(pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out.
For assay n° 1, various concentrations of test item were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2, various concentrations of test item were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental “historical” values obtained in the laboratory.
There is no evidence of any increase in the number of revertant colonies in the presence of the various concentrations of the test item (5 000, 1 500, 500, 150 and 50 μg/plate), without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA ̄) (pKM 101).
These results validate the two tests.
Conclusion:
Under the assay conditions the test item did not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 strains and Escherichia coli WP2(uvr A ̄)(pKM101) strain without, or with metabolic activation, according to the OECD Guideline n° 471.
Reference
Results tables and HCD are included in attachment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Table 7.6.1/1 : Summary of genotoxicity tests:
Test n° | Test Guideline / Reliability | Focus | Strains / cells tested | Metabolic activation | Test concentration | Statement |
1 (2022) | Ames Test (OECD 471, GLP) K, rel.1 | Gene mutation | S. typhimurium TA 1535, TA 1537, TA 98, TA 100, E. coli WP2(uvrA-) | -S9 +S9 | Tested up to recommended limit concentrations | -S9: not mutagenic + S9: not mutagenic |
Gene mutation Assay (Test n° 1)
A bacterial reverse mutation assay (Ames test) was performed with the substance (Test n°1). This study was used to conclude on the potential of the substance to induce gene mutation in bacteria.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains with any dose of test material, either in the presence or absence of metabolic activation. The test indicate that the substance does not induce gene mutations in bacteria whereas all positive control chemicals (with and without metabolic activation) induced significant increase of colonies. The substance is therefore considered as non-mutagenic according to the Ames test.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information, no additional classification is proposed according to the CLP and the GHS.
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.