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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 906-521-8 | CAS number: -
- 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:
- weight of evidence
- Study period:
- Mar to May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate
- EC Number:
- 906-521-8
- Cas Number:
- 85391-60-2
- Molecular formula:
- C8H16N2O6
- IUPAC Name:
- Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: P2D5000133
- Purity: 100 %
- Expiration date of the lot/batch: 2015-06-12
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 50, 160, 500, 1600, 5000 µg/plate (without and with S9 mix)
- Vehicle / solvent:
- Solvents used: demineralized water (test substance), deionized water (mitomycin C), DMSO (sodium azide, cumene hydroperoxide, 2-nitrofluorene, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA 100, TA 1535), 2-nitrofluorene (TA 98), 4-nitro-1,2-phenylene diamine (TA 1537), mitomycin C (TA 102, plate incorp.), cumene hyd (TA 102, preincub. trials), 2-aminoanthracene (all strains)
- Remarks:
- The positive controls sodium azide, 2-nitrofluorene, 4-nitro-1,2-phenylene diamine, mitomycin C and cumene hydroperoxide were only used without S9 mix; the positive control 2-aminoanthracene was only used with S9 mix.
- Details on test system and experimental conditions:
- METHOD: Standard plate test and preincubation test
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 1537, TA 100 and TA 98 this increase should be about twice that of negative controls. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these criteria may be overruled by good scientific judgment. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
- Statistics:
- not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 102, TA 1535, 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 102, 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- 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
- Remarks on result:
- other: plate incorporation test
Any other information on results incl. tables
Table 1: Summary of results from the Salmonella mutagenicity assay (plate incorporation test) with KGD 1409 (mean values of revertants per plate)
Dose (µg per plate) |
Without metabolic activation |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
Vehicle control (demin. water) |
13 |
110 |
5 |
16 |
205 |
50 |
10 |
104 |
4 |
16 |
210 |
160 |
10 |
91 |
6 |
12 |
218 |
500 |
9 |
97 |
5 |
14 |
200 |
1600 |
10 |
92 |
6 |
15 |
201 |
5000 |
15 |
111 |
4 |
18 |
203 |
Positive control |
660 |
1395 |
39 |
1167 |
782 |
Dose (µg per plate ) |
With metabolic activation (liver S9 mix) |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
|
Vehicle control (demin. water) |
12 |
154 |
9 |
28 |
296 |
50 |
11 |
139 |
9 |
29 |
329 |
160 |
11 |
164 |
10 |
26 |
321 |
500 |
13 |
134 |
8 |
31 |
301 |
1600 |
15 |
148 |
8 |
25 |
300 |
5000 |
20 |
144 |
8 |
26 |
272 |
Positive control |
132 |
2980 |
279 |
2791 |
1158 |
Table 2: Summary of results from the Salmonella mutagenicity assay (independent preincubation test) with KGD 1409 (mean values of revertants per plate)
Dose (µg per plate) |
Without metabolic activation |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
Vehicle control (demin. water) |
10 |
114 |
6 |
16 |
240 |
50 |
10 |
114 |
7 |
21 |
245 |
160 |
8 |
111 |
7 |
20 |
261 |
500 |
10 |
105 |
6 |
13 |
253 |
1600 |
8 |
109 |
7 |
16 |
259 |
5000 |
20 |
118 |
8 |
17 |
265 |
Positive control |
656 |
842 |
37 |
1101 |
550 |
Dose (µg per plate) |
With metabolic activation (liver S9 mix) |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
|
Vehicle control (demin. water) |
10 |
156 |
10 |
27 |
334 |
50 |
10 |
150 |
8 |
28 |
343 |
160 |
11 |
162 |
9 |
27 |
341 |
500 |
9 |
164 |
9 |
28 |
339 |
1600 |
15 |
162 |
8 |
26 |
359 |
5000 |
25 |
178 |
8 |
28 |
337 |
Positive control |
239 |
2204 |
382 |
2251 |
1013 |
Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects or precipitations.
Evidence of mutagenic activity of the test item was seen. On Salmonella typhimurium TA1535, a biologically relevant increase was found in the mutant count compared to the corresponding solvent control when using the preincubation method. Both with and without S9 mix, there was a positive response. The lowest reproducible effective dose was 5000 µg per plate for Salmonella typhimurium TA1535. The Salmonella/microsome test thus showed the test item to have a mutagenic effect.
In both experiments the positive controls sodium azide, 4-nitro-1,2-phenylene diamine, 2-nitrofluoren, mitomycin C, cumene hydroperoxide and 2-aminoanthracene increased mutant counts to well over those of the solvent controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.
Applicant's summary and conclusion
- Conclusions:
- positive
- Executive summary:
The mutagenic potential of KGD 1409 was evaluated in a Salmonella/microsome test (plate incorporation test and preincubation methood) with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471.
Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects or precipitations.
Evidence of mutagenic activity of the test item was seen. On Salmonella typhimurium TA1535, a biologically relevant increase was found in the mutant count compared to the corresponding solvent control when using the preincubation method. Both with and without S9 mix, there was a positive response. The lowest reproducible effective dose was 5000 µg per plate for Salmonella typhimurium TA1535.
Therefore, the test item was considered to be mutagenic without and with S9 mix in the preincubation modification of the Salmonella/microsome test.
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.