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EC number: 939-498-8 | 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted July 21, 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- S 611411
- IUPAC Name:
- S 611411
- Details on test material:
- - Name of test material (as cited in study report): C-SAT 050084, DHW 80 (50%)
- Physical state: Liquid to solid, yellow to orange
- Composition of test material, percentage of components: approximately 50 % active substance, 49.3 % water
- Impurities (identity and concentrations): Ammonium-9,10-dihydroxystearat: ~ 35-40%, Polycondensationproducts: ~10-15%, NH4OH: <= 2%
- Lot/batch No.: CD53120004
- Expiration date of the lot/batch: 2006-11-08
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature
- Other: well soluble in water, test item was heated up to 50°C in order to obtain a homogenous solution
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: males mean value 32g (SD ± 2.2g), females mean value 29.7g (SD ± 1.89g)
- Assigned to test groups randomly: yes
- Housing: individual, on granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen) in Makrolon Type I cages with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
- Diet: pelleted standard diet (Harlan Winkelmann, D-33178 Borchen), ad libitum
- Water: tap water (Gemeindewerke, D-64380 Roßdorf), ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): artificial light 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: item is well soluble in water
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw
- Lot/batch no. (if required): 18.11.05 - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
at beginning of treatment animals were weighed and individual volume to be administered was adjusted to animal body weight - Duration of treatment / exposure:
- 24 and 48 hours
- Frequency of treatment:
- single exposure
- Post exposure period:
- 24 and 48 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500, 1000, 2000 mg/kg bw after 24 hours
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw after 48 hours
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide - Sigma-Aldrich Vertriebs GmbH, 82041 Deisenhofen
- Catalogue no.: C 0768 (purity: >98%)
- dissolved in: deionised water
- Route of administration: orally, once
- Doses / concentrations: 40 mg/kg bw (10 mL/kg bw administered)
Examinations
- Tissues and cell types examined:
- tissue: bone marrow
cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
a preliminary study on acute dose selection was performed with two animals per sex under identical conditions as the mutagenicity study; animals were treated orally and examined for acute toxicity symptoms at 1, 2-4, 6, 24, 30 and 48 h after administration
DETAILS OF SLIDE PREPARATION:
slides were air dried and stained with May-Grünwald (MERCK, D-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain), cover slips were mounted with EUKITT (KINDLER, D-79110 Freiburg)
METHOD OF ANALYSIS:
ten animals (5 males/5 females) were evaluated per test group, at least one slide was made from each bone marrow sample, evaluation was performed using NIKON microscopes with 100x oil immersion objectives, at least 2000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei, cytotoxicity was determined by ratio of polychromatic and normochromatic erythrocytes - Evaluation criteria:
- - test item is classified as mutagenic, if it induces a dose-related or a clear increase in number of micronucleated polychromatic erythrocytes in a single dose group
- primary point of consideration is the biological relevance of the results, if test item fails to produce biological relevant increase in number of micronucleated PCEs it is considered non-mutagenic in this system - Statistics:
- nonparametrix Mann-Whitney test was used as an aid in evaluating results
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- animals of all dose groups showed: reduction of spontaneous activity and ruffeled fur; animals of high dose group: difficulty breathing and one male/female animal died
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: vehicle control is negative control
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 100 - 2000 mg/kg bw
- Clinical signs of toxicity in test animals: reduction of spontaneous activity and ruffled fur in all dose groups; eyelid closure in 100 and 500 mg/kg bw group
- Harvest times: up to 48 hours after exposure
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): in comparison to vehicle controls there was no statistically significant or biologically relevant enhancement in the frequency of detected micronuclei at any preparation interval or dose level
- Ratio of PCE/NCE (for Micronucleus assay): no differences observed between treated groups and vehicle control groups
- Statistical evaluation: non-parametric Mann-Whitney test
(for details of toxicity and micronucleustest refer to tables1-4)
Any other information on results incl. tables
table1a-c: toxic symptoms in main experiment
Toxic reactions (a) 500 mg/kg bw |
Hours post-treatment male/female |
|||
1 h |
2-4 h |
6 h |
24 h |
|
Reduction of spontaneous activity |
2/3 |
4/5 |
0/0 |
0/0 |
Ruffeled fur |
4/3 |
4/5 |
0/0 |
0/0 |
Toxic reactions (b) 1000 mg/kg bw |
Hours post-treatment male/female |
|||
1 h |
2-4 h |
6 h |
24 h |
|
Reduction of spontaneous activity |
0/0 |
4/5 |
0/0 |
0/0 |
Ruffeled fur |
4/3 |
4/5 |
0/0 |
0/0 |
Toxic reactions (c) 2000 mg/kg bw |
Hours post-treatment male/female |
|||
1 h |
2-4 h |
6 h |
24 h |
|
Reduction of spontaneous activity |
5/4 |
12/12 |
0/0 |
0/0 |
Eyelid closure |
0/0 |
0/2 |
0/0 |
0/0 |
Ruffeled fur |
7/7 |
12/12 |
0/0 |
0/0 |
Difficulty in breathing |
0/0 |
0/0 |
0/0 |
0/0 |
Death |
0/0 |
0/0 |
0/0 |
1/1 |
table2: historical controls micronucleus test
|
Vehicle Controls |
Positive Controls (CPA) |
||||
|
Males |
Females |
Total |
Males |
Females |
Total |
Mean* ± SD |
0.078±0.04 |
0.058±0.033 |
0.069±0.028 |
1.867±0.57 |
1.368±0.497 |
1.632±0.468 |
Range** |
0.01±0.23 |
0.0±0.19 |
0.01±0.15 |
0.70±3.46 |
0.49±3.55 |
0.77±3.48 |
No. of experiments |
229 |
217 |
230 |
228 |
217 |
229 |
* mean value (percent micronucleated cells)
** range of the mean group values (percent micronucleated cells)
table3: summary of micronucleus test result
test group |
dose mg/kg bw |
Sampling time (h) |
PCEs with micronuclei (%) |
Range |
PCE per 2000 erythrocytes |
vehicle |
0 |
24 |
0.075 |
0 - 7 |
1188 |
test item |
500 |
24 |
0.120 |
1 - 4 |
1103 |
test item |
1000 |
24 |
0.090 |
0 - 5 |
1162 |
test item |
2000 |
24 |
0.100 |
0 - 5 |
1103 |
positive control |
40 |
24 |
2.770 |
32 – 91 |
1042 |
test item |
2000 |
48 |
0.100 |
0 - 5 |
1194 |
table4: biometry, statistical significance (p<0.05) evaluated by non-parametric Mann-whitney test
vehicle control versus test group |
Significance |
P |
500 mg/kg bw; 24 h |
no |
0.0684 |
1000 mg/kg bw; 24 h |
no |
0.3598 |
2000 mg/kg bw; 24 h |
no |
0.2185 |
40 mg/kg bw CPA; 24 h |
yes |
<0.0001 |
2000 mg/kg bw; 48 h |
no |
0.2809 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test in bone marrow cells of the mouse.
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