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EC number: 940-223-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Glycine, N-coco acyl derivs., sodium salts
- EC Number:
- 291-350-5
- EC Name:
- Glycine, N-coco acyl derivs., sodium salts
- Cas Number:
- 90387-74-9
- Details on test material:
- - Name of test material (as cited in study report): Sodium cocoyl glycinate
- Physical state: liquid
- Analytical purity: 28% active
- Composition of test material, percentage of components: 28% active, sodium chloride, water
- Lot/batch No.: 970925
- Expiration date of the lot/batch: 1999
- Stability under test conditions: stable
- Storage condition of test material: refrigerated and shielded conditions
Constituent 1
- Specific details on test material used for the study:
- The test material is equivalent to the commercial product of the registration substance.
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 33.2 - 40.6 g
- Assigned to test groups randomly: yes
- Housing: aluminium box-type cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15 cycles per hour
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiological saline
- Justification for choice of solvent/vehicle: recommended vehicle
- Concentration of test material in vehicle: 0.5, 1, 2 and 4 % (w/v) - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- two intraperitoneal injections within a 24 hour interval
- Post exposure period:
- no post exposure period
Doses / concentrationsopen allclose all
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 50 mg/kg bw/day
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C
Examinations
- Tissues and cell types examined:
- bone marrow from right femur
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Doses were selected on the basis of a preliminary dose-range finder.
TREATMENT AND SAMPLING TIMES:
Treatment period was 24 hours. The test solutions were administered intraperitoneally, twice within this 24 hour time interval.
DETAILS OF SLIDE PREPARATION:
METHOD OF ANALYSIS:
OTHER:
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 250, 500, 1000, 2000 mg/kg body weight
- Solubility: yes
- Clinical signs of toxicity in test animals: yes
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no induction of micronuclei
- Appropriateness of dose levels and route: dose levels based on pre-test, intraperitoneal administration is a recommended route
- Statistical evaluation: yes
Any other information on results incl. tables
Results of micronucleus test in male CD-1 mice after introperitoneal administration of sodium N-cocoyl glycinate |
|||
Concentrations (mg/mL) |
No. of animals survived / No, of animals treated |
Frequency of MNPCE (%) |
PCE/RBC |
Solvent control |
6/6 |
0.07 ± 0.08 |
58.8 ± 2.68 |
50 x 2 |
6/6 |
0.18 ± 0.10 |
59.5 ± 7.45 |
100 x 2 |
6/6 |
0.07 ± 0.10 |
** 48.8 ± 5.83 |
200 x 2 |
5/6 |
0.08 ± 0.11 |
** 36.8 ± 4.61 |
400 x 2 |
2/6 |
0.10 |
* 50.6 ± 2.69 |
Positive control (MMC) |
6/6 |
4.77 ± 1.02 |
* 50.6 ± 2.69 |
PCE: polychromatic erythrocytes RBC: total erythrocytes MNPCE: micronucleated PCE MMC: mitomycin C * significantly different from solvent control (P< 0.05) ** significantly different from solvent control (P < 0.01) |
Applicant's summary and conclusion
- Conclusions:
- The in-vivo clastogenicity of Hostapon SG was investigated in micronucleus study in bone marrow in mice. No significant clastogenicity was found.
- Executive summary:
The in-vivo clastogenicity of Hostapon SG was investigated in micronucleus study in bone marrow in mice. Male mice were treated intraperitoneally at concentrations of 400, 200, 100 and 50 mg/kg bw, twice with a 24 hours interval. One death was observed in the 200 mg/kg body weight group (1/6 cases), and four deaths were observed in the 400 mg/kg body weight group (4/6 cases). The surviving animals were killed at 24 hours after the final treatment and the bone-marrow smears were prepared. The proportion of polychromatic erythrocytes (PCE) to total erythrocytes was lower in the 100 and 200 mg/kg bw groups, indicating toxic effect in the bone marrow tissue. The percentage of micronucleated polychromatic ethythrocytes (MNPCE) in the treated group was not significantly higher than that in the negative control group.
Hostapon SG is not clastogenic in in-vivo test system.
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