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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-047-0 | CAS number: 506-61-6
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 6 May 2022 to 23 December 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study has been performed in accordance with OECD test guideline and followed GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Potassium dicyanoargentate
- EC Number:
- 208-047-0
- EC Name:
- Potassium dicyanoargentate
- Cas Number:
- 506-61-6
- Molecular formula:
- C2AgN2.K
- IUPAC Name:
- Potassium silver(1+) cyanide (1:1:2)
- Test material form:
- solid: particulate/powder
- Remarks:
- white powder
- Details on test material:
- - Lot/batch No.: 311-21
- pH: 9.27 - 9.60
- Solubility in vehicle: 145 g/L in water
Constituent 1
- Specific details on test material used for the study:
- - Expiry date: 17 December 2026 (5 year expiry date applied)
- Storage condition: at room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI(Han)
- Details on species / strain selection:
- The Wistar Han rat was the species and strain of choice because it is readily available rodent, which is commonly used for genotoxicity testing, with documented susceptibility to a wide range of toxic materials. Moreover, historical control background data has been generated with this strain.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Animal sex: since there were no substantial differences in toxicity between sexes only in males were used in the main study.
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 6-9 weeks
- Weight at study initiation: within 20% of sex mean
- Assigned to test groups randomly: yes - the animals were allocated at random to treatment groups. Males and females were randomized separately. Animals in poor health or at extremes of body weight range were not assigned to groups. Females were nulliparous and non-pregnant.
- Identification: rats were identified with a unique number on the tail written with marker pen.
- Fasting period before study:
- Housing: Polycarbonate cages (Makrolon MIV type or 2000P Tecniplast) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. Up to 5 animals of the same sex and same dosing group were housed together.
- Cage identification: Colour-coded cage card indicating Test Facility Study No; group animal number(s).
- Animal Enrichment: Animals were socially housed for psychological/environmental enrichment and were provided with materials such as devices for hiding in, paper and/or objects for chewing, except when interrupted by study procedures/activities.
- Diet (e.g. ad libitum): SM R/M-Z from SSNIFF Spezialdiäten GmbH, Soest, Germany
- Type of diet: Pellets
- Frequency: Ad libitum, except during designed procedures
- Analysis: Results of analysis for nutritional components and environmental contaminants were provided by the supplier and are on file at the Test Facility. It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.
- Water (e.g. ad libitum): Municipal tap water
- Frequency: freely available to each animal via water bottles
- Analysis: Periodic analysis of the water was performed, and results of these analyses are on file at the Test Facility. it is considered that there were no known contaminants in the water that could interfere with the outcome of the study.
- Acclimation period: The animals were allowed to acclimate to the Test Facility toxicology accommodation for at least 5 days before the commencement of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): ten or more air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark (except during designed procedures)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: mili-Q water
- Concentration of test material in vehicle: 450mg/L - 900 mg/L - 1800 mg/L
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw meaning 1.75 mL per animal
Preparation of test material: No correction factor was made for the purity / composition of test material.
A solubility test was performed based on visual assessment. The test material was dissolved in Milli-Q Water (Millipore Corp., Bedford, MA., USA). The specific gravity of Mili-Q water is 1.0g/mL. Test material concentrations were vortexed until the test material is completely dissolved.
This resulted in colourless solutions for all formulations. Test material concentrations were dosed within 4 hours after preparation.
Sample collection and Analysis: Dose formulation samples were collected for analysis as indicated in the section "Any other information on Materials and Methods" - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test item formulations were prepared and subsequently dosed within 4 hours.
- Duration of treatment / exposure:
- 3 consecutive days
- Frequency of treatment:
- once per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 18 mg/kg bw/day
- Dose / conc.:
- 9 mg/kg bw/day
- Dose / conc.:
- 4.5 mg/kg bw/day
- No. of animals per sex per dose:
- In the dose range finding: 3 animal/dose/group (3 males and 3 females)
In the main study: 5 male rats per dose - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive control for micronucleus test was Cyclophosphamide (CP; CAS 6055-19-2)
- Route of administration: oral gavage
- Frequency: twice (once daily)
- Method: a limited quantity of food was supplied during the night before last dosing (approximately 7g/rat). The dose was given using a plastic feeding tube. The dosing volume was 10mL/kg bw.
- Doses / concentrations: 19 mg/kg bw dissolved in physiological saline.
Examinations
- Tissues and cell types examined:
- 1. Isolation of Cells:
Approximately 3-4 hours after the third treatment with the test material bone marrow was isolated for the micronucleus test - Details of tissue and slide preparation:
- 1. Preparation of bone marrow smears:
The supernatant was removed with a Pasteur pipette. Approximately 500 µl serum was left on the pellet. The cells in the sediment were carefully mixed with the remaining serum. A drop of the cell suspension was placed on the end of a clean slide, which was previously immersed in a 1:1 mixture of 96% (v/v) ethanol and cleaned with a tissue. The slides were marked with the study identification number and the animal number. The drop was spread by moving a clean slide with round-whetted sides at an angle of approximately 45° over the slide with the drop of bone marrow suspension. The preparations were air-dried, fixed for 5 min in 100% methanol and air-dried overnight. At least two slides were prepared per animal.
2. Staining of the bone marrow smears:
The slides were automatically stained using the "wright-stain-procedure" in a HEMA-tek slide stainer. This staining is based on Giemsa. The dry slides were automatically mounted with a coverslip with an automated coverslipper.
3. Analysis of the bone marrow smears for micronuclei:
To prevent bias, all slides were randomly coded before examination. At first, the slides were screened at a magnification of 100 x for regions of suitable technical quality, i.e. where the cells were well spread, undamaged and well stained. Slides were scored at a magnification of 1000 x. The number of micronucleated polychromatic erythrocytes was counted in at least 4000 polychromatic erythrocytes (with a maximum deviation of 5%). The ratio of polychromatic to normochromatic erythrocytes was determined by counting and differentiating at least the first 500 erythrocytes at the same time. Micronuclei were only counted in polychromatic erythrocytes. Averages and standard deviations were calculated. Parts on the slides that contained mast cells that might interfere with the scoring of micronucleated polychromatic erythrocytes were not used for scoring - Evaluation criteria:
- Acceptance criteria:
A micronucleus test is considered acceptable if it meets the following criteria:
- The concurrent negative control data are considered acceptable when they are within the 95% control limits of the distribution of the historical negative control database.
- The concurrent positive controls should induce responses that are compatible with those generated in the historical positive control database.
- The positive control material induces a statistically significant increase in the frequency of micronucleated polychromatic erythrocytes. - Statistics:
- ToxRat Professional v 3.3.0 (ToxRat Solution GmbH, Germany) was used for statistical analysis of the data.
A test material is considered positive in the micronucleus test if all of the following criteria are met:
- at least one of the treatment groups exhibits a statistically significant (one-sides, p< 0.05) increase in the frequency of micronucleated polychromatic erythrocytes compared with the concurrent negative control.
- The increase is dose related when evaluated with a trend test
- Any of the results are outside the 95% control limits of the historical control data range.
A test material is considered negative in the micronucleus test if:
- None of the treatment groups exhibits a statistically significant increase in the frequency of micronucleated polychromatic erythrocytes compared with the concurrent negative control.
- There is no concentration-related increase when evaluated with a trend test.
- All results are within the 95% control limits of the negative historical control data range.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- All test item dosed in animals showed increased levels of the test item in the blood, confirming systemic exposure.
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Dose Formulation sample collection schedule
Interval | Concentration (M) | Homogeneity (TMB) | Sampling From |
Single Occasion | All groups 2x approximately 500mg | Groups 2 and 4 Approximately 500 mg | Dosing containing |
M= sample collected from approximately Middle; TMB = sample collected from approximately Top, Middle and Bottom
The homogeneity results obtained from top, middle and bottom for groups 2 and 4 was averaged and utilized as the concentration results.
Accuracy: a small response was observed in the vehicle. It was considered to possibly derive from the vehicle since the response was approximately double that of the analytical blanks. However, the maximum contribution to the samples was 0.16%, therefore, this observed small response is not considered to have impacted the outcome of the study.
The concentration analyzed in the dose formulation samples were in agreement with target concentrations (i.e. mean sample concentration results were within or equal to 90%-110%)
Homogeneity: The dose formulation samples wre homogeneous
Unscheduled deaths:
In the Dose-range finding, one animal dosed with 20 mg/kg bw was euthanized for humane reasons.
In the Main study, one animal from the highest dosed group (18 mg/kg bw) euthanized for humane reasons.
Animals were deeply anaesthetized using isoflurane and subsequently exsanguinated.
Dose Range finding results:
During the dose-range finding study, at a dose level of 20 mg/kg rough coat and lethargy was observed in 1 male and 1 female, and the female animal showed so severe clinical symptoms after the third dosing it was prematurely euthanized.
At a dose level of 15 mg/kg no clinical symptoms were observed in 1 male and 1 female.
At a dose level of 18 mg/kg 1 male and 1 female had diarrhea after dosing and a rough coat on day three.
Two additional males had a rough coat after the first dosing. With these low dose levels and the small dosing steps, and the quick onset of severe symptoms, 18 mg/kg bw is determined to be the MTD.
In a dose-range finding study 10 animals (group 1 and 2: 1 male and 1 female, group 3: 3 males and 3 females) were dosed via oral gavage with 20, 15 and 18 mg/kg bw (group 1, 2 and 3, respectively).
Mortality and Toxic Signs in the Dose-range Finding Study | ||||||||||
Toxic signs* | ||||||||||
Group | Sex | Animal Number | Dose mg/kg | Day 1 | Day 2 | Day 3 | Day4 | |||
Post-dose | Pre-dose | Post-dose | Pre-dose | Post-dose | Post-dose (additional observation) | |||||
1 | Male | 101 | 20 | F | B | F, N | F, N | F, N | F, N | B |
1 | Female | 102 | 20 | F, N | B | F, N | F, N | D, E, F, N, O, Q, X (1) | NA | NA |
2 | Male | 103 | 15 | B | B | B | B | B | 2) | B |
2 | Female | 104 | 15 | B | B | B | B | B | 2) | B |
3 | Male | 105 | 18 | N | B | N | B | N | 2) | 2) |
3 | Female | 106 | 18 | N | B | N | B | N | 2) | 2) |
3 | Male | 107 | 18 | N | B | B | B | B | 2) | 2) |
3 | Male | 108 | 18 | N | B | B | B | B | 2) | 2) |
3 | Female | 109 | 18 | B | B | B | B | B | 2) | 2) |
3 | Female | 110 | 18 | B | B | B | B | B | 2) | 2) |
* Legend "mortality and toxic signs"
NA= Not Applicable; B= showed no abnormalities; D= convulsions; E= tremors; F= lethargy; N= rough coat; O= pale skin; Q= quick breathing; X= pinched eyes
(1)= Sacrificed for humane reasons
2) Animal not observed
Main study:
Mean body weight per group recorded prior to dosing:
Group code | dose (mg/kg bw | Day 1 Body weight gram (Mean +/- S.D) | Day 2 Body weight gram (Mean +/-SD) | Day 3 Body weight gram (Mean +/- SD) |
1 | 0 | 176,4 +/- 4,2 | 180 +/- 4,4 | 173,2 +/- 3,1 |
2 | 4,5 | 173,8 +/- 10,5 | 175,2 +/- 13,0 | 171,6 +/- 8,7 |
3 | 9 | 176,4 +/- 11,6 | 175,8 +/- 15,7 | 172,6 +/- 13,5 |
4 | 18 | 179,1 +/- 9,3 | 184,9 +/-9,5 | 180,7 +/- 9,5 |
TK 1 | 0 | 178,3 +/- 6,4 | 182,7 +/- 3,5 | not dosed |
TK 4 | 18 | 171,7 +/- 16,2 | 174,3 +/- 15,9 | not dosed |
Group 1: control - Group 2: 4.5 mg/kg bw - Group 3: 9 mg/kg bw - Group 4: 18 mg/kg bw
Mortality and Toxic Signs after treatment in the main study
Mortality and Toxicity Signs after Treatment in the Main Study | ||||||||
Toxic signs | ||||||||
Group | Sex | Animal Number | Dose mg/kg | day 1 post-dose within | day 2 pre-dose | day 2 post-dose within | day 3 pre-dose | day 3 post-dose within |
1 | Male | 1 | 0 | B | B | B | B | B |
1 | Male | 2 | 0 | B | B | B | B | B |
1 | Male | 3 | 0 | B | B | B | B | B |
1 | Male | 4 | 0 | B | B | B | B | B |
1 | Male | 5 | 0 | B | B | B | B | B |
2 | Male | 6 | 4,5 | B | B | B | B | B |
2 | Male | 7 | 4,5 | B | B | B | B | B |
2 | Male | 8 | 4,5 | B | B | B | B | B |
2 | Male | 9 | 4,5 | B | B | B | B | B |
2 | Male | 10 | 4,5 | B | B | B | B | B |
3 | Male | 11 | 9 | B | B | B | B | B |
3 | Male | 12 | 9 | B | B | B | B | B |
3 | Male | 13 | 9 | B | B | B | B | B |
3 | Male | 14 | 9 | B | B | B | B | B |
3 | Male | 15 | 9 | B | B | B | B | B |
4 | Male | 16 | 18 | B | B | B | B | B |
4 | Male | 17 | 18 | B | B | B | B | B |
4 | Male | 18 | 18 | B | B | B | B | B |
4 | Male | 19 | 18 | B | B | B | B | B |
4 | Male | 20 | 18 | B | B | B | B | B |
4 | Male | 21 | 18 | B | B | B | B | B |
4 | Male | 22 | 18 | B | B | B | B | B |
4 | Male | 23 | 18 | D, E, F, G, O | NA | NA | NA | NA |
TK 1 | Male | 27 | 0 | B | B | B | B | B |
TK 1 | Male | 28 | 0 | B | B | B | B | B |
TK 1 | Male | 29 | 0 | B | B | B | B | B |
TK 4 | Male | 30 | 18 | B | B | F | B | B |
TK 4 | Male | 31 | 18 | B | B | F | B | B |
TK 4 | Male | 32 | 18 | B | B | F | B | B |
Mean Number of Micronucleated Polychromatic Erythrocytes and Ratio of Polychromatic/Normochromatic Erythrocytes
Group | Treatment | Number of Animals | Dose (mg/kg bw/day) | Number of micronucleated polychromatic erythrocytes (mean +/-SD) | Ration polychromatic/normochromatic erythrocytes (mean +/-SD) |
1 | vehicle control | 5 | 0 | 4,2 +/- 2,5 | 0,94 +/- 0,07 |
2 | test item | 5 | 4,5 | 2,8 +/- 0,8 | 0,94 +/- 0,06 |
3 | test item | 5 | 9 | 1,6 +/- 0,5 | 0,95 +/- 0,02 |
4 | test item | 5 | 18 | 2 +/- 1,2 | 0,97 +/- 0,03 |
5 | CP | 3 | 19 | 71 +/- 14,8 | 0,28 +/- 0,01 |
Individual Data Micronucleus Assay
Group | Animal number | Number of polychromatic erythrocytes | Number of normochromatic erythrocytes | Ratio polychromatic/normochromatic erythrocytes | Number of micronucleated polychromatic erythrocytes | Number of polychromatic erythrocytes scored for micronuclei |
1 | 1 | 498 | 503 | 0,99 | 2 | 4005 |
1 | 2 | 499 | 505 | 0,99 | 5 | 4010 |
1 | 3 | 451 | 553 | 0,82 | 4 | 4014 |
1 | 4 | 497 | 509 | 0,98 | 2 | 4001 |
1 | 5 | 494 | 528 | 0,94 | 8 | 4000 |
2 | 6 | 483 | 518 | 0,93 | 4 | 4001 |
2 | 7 | 498 | 503 | 0,99 | 3 | 4006 |
2 | 8 | 468 | 550 | 0,85 | 2 | 4008 |
2 | 9 | 492 | 513 | 0,96 | 2 | 4000 |
2 | 10 | 497 | 507 | 0,98 | 3 | 4020 |
3 | 11 | 486 | 518 | 0,94 | 1 | 4000 |
3 | 12 | 492 | 526 | 0,94 | 2 | 4006 |
3 | 13 | 493 | 507 | 0,97 | 2 | 4026 |
3 | 14 | 496 | 509 | 0,97 | 1 | 4004 |
3 | 15 | 491 | 516 | 0,95 | 2 | 4013 |
4 | 16 | 496 | 506 | 0,97 | 1 | 4002 |
4 | 17 | 499 | 501 | 1 | 4 | 4010 |
4 | 18 | 484 | 522 | 0,93 | 2 | 4027 |
4 | 19 | 498 | 506 | 0,98 | 1 | 4005 |
4 | 20 | 493 | 507 | 0,97 | 2 | 4004 |
(2) | 113 | 223 | 778 | 0,29 | 78 | 4000 |
(2) | 114 | 208 | 792 | 0,26 | 81 | 4000 |
(2) | 115 | 218 | 789 | 0,28 | 54 | 4000 |
(2) Positive control slides taken from male animals previously dosed with CP were added to the study slides for evaluation as scoring controls.
Historical Positive control data for Micronucleus | |||
Male | |||
Mean Number of micronucleated cells per 4000 cells | 34,6 | ||
SD | 23,6 | ||
n | 55 | ||
Lower control limit (95% control limit) | -12 | ||
Upper control limit (95% control limit) | 81 | ||
SD: standard deviation | |||
n= number of observations | |||
HCD from experiments in May 2019 to May 2022 |
Micronucleated Polychromatic Erythrocytes:
No increase in the mean frequency of micronucleated polychromatic erythrocytes was observed in the bone marrow of test item treated animals compared to the vehicle treated animals.
The incidence of micronucleated polychromatic erythrocytes in the bone marrow of all negative control animals was within the 95% control limites of the distribution of the historical negative control database.
Cyclophosphamide, the positive control material, induced a statistically significant increase in the number of micronucleated polychromatic erythrocytes. In addition, the number of micronucleated polychromatic erythrocytes found in the positive control animals was within the 95% control limits of the distribution of the historical positive control database.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item is not clastogenic or aneugenic in the bone marrow micronucleus test of male rats up to a dose of 18 mg/kg bw (MTD) under the experimental conditions.
All criteria for an acceptable assay were met. - Executive summary:
The test item was administered to Wistar Han rat (male) at the maximum recommended dose in accordance with OECD 474 guideline and followed GLP principles. The potential genotoxicity was assessed by measuring the increase in the number of micronucleated polychromatic erythrocytes per 4000 polychromatic erythrocytes in rat bone marrow..
Based on the results of the dose-range finding study test concentrations of 18 mg/kg bw/day for male animals was selected as maximum tolerated dose for the main test. The test item was dissolved in Milli-Q water.
In the main study male animals were dosed three times by oral gavage with vehicle or with 4.5, 9 and 18 mg test material per kg body weight for three consecutive days. A positive control group slides from male animals previously dosed with 19 mg cyclophosphamide were added to this study for evaluation as scoring controls. In total 5 treatment groups were used, each consisting of 5 animals with exception of positive control and TK animals and high dose group (8 animals).
Clinical signs of toxicity were limited to the high dose groupo and included lethargy. Only one animal showed signs of toxicity and included convulsions, tremors, lethargy, no reaction to stimulus and pale skin.
Approximately 3-4 hours after the last dose the animals were sacrified by abdominal aorta bleeding under isoflurane anesthesia. Bone marrow smears were prepared for micronucleus analysis.
No increase in the mean frequency of micronucleated polychromatic erythrocytes was observed in the bone marrow of animals treated with the test item compared to the vehicle treated animals. The incidence of micronucleated polychromic erythrocytes in the bone marrow of all negative control animals was within the 95% control limits of the distribution of the historical negative control database. Cyclophosphamide, the positive control material, induced a statistically significant increase in the number of micronuclei. In addition, the number of micronuclei found in the positive control animals was within 95% control limits of the distribution of the historical positive control database. hence, all criteria for an acceptable assay were met.
The groups that were treated with the test item showed no decrease in the ratio of polychromatic to normochromatic erythrocytes compared to the concurrent vehicle control group, indicating a lack of toxic effects of this test item on erythropoiesis. The group that was treated with cyclophosphamide showed an expected decrease in the ratio of polychromatic to normochromatic erythrocytes compared to the vehicle control, demonstrating toxic effect on erythropoiesis.
In conclusion, the test item is not clastogenic or aneugenic in the bone marrow micronucleus test of male rats up to a dose of 18 mg/kg bw (MTD) under the experimental conditions.
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.