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EC number: 291-350-5 | CAS number: 90387-74-9
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
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
- Molecular formula:
- Molecular formula for this UVCB is not available.
- IUPAC Name:
- Glycine, N-coco acyl derivs., sodium salts
Constituent 1
- Specific details on test material used for the study:
- Sodium cocoyl glycinate (clear liquid, Lot No. 970925, purity: 28.0% w/w) provided by Ajinomoto Co., Inc.
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- For this test 7-week-old male ICR (Crj: CD-1) SPF mice were purchased from Japan Biomaterial Center. The mice were produced by Charles River Japan, Inc.. The animals were kept in the laboratory for eight days for quarantine and acclimatization. Following physical examination, the mice were used in the tests with an age of 8 weeks. The range of body weights at the first administration was 34.5 to 39.1 g in the dose-finding test and 33.2 to 40.6 g in the main test. The animals were stratified with the body weight on the final day of the acclimatization period, and then randomly assigned to one of the test groups using random numbers produced by a computer. Six mice were assigned to each group in both the dose-finding test and the main test. A total of 36 male mice were used in each test. Six mice (the whole group) were kept in one cage.
The animals were kept in aluminum box-type cages. The temperature was set at 20 to 26°C, and relative humidity was set at 40 to 70%. The lighting period was set to 12 hours and the ventilation cycle was set at 10 to 15 cycles per hour.
Autoclaved floor chips were placed on the floor of the cage.
The animals had free access to commercially available radiation-sterilized solid food and tap water from a water bottle.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiol. saline
- Details on exposure:
- The required amount of the test item was weighed out and diluted with physiological saline to prepare 400, 200, 100 and 50 mg/kg solutions (4, 2, 1 and 0.5 % [w/v]) for use in the main test.
- Duration of treatment / exposure:
- The animals received intraperitoneal administration twice (24-hour interval)
- Frequency of treatment:
- see above
- Post exposure period:
- see below
Doses / concentrations
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Remarks:
- 50-400 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Positive control(s):
- The animals in the positive control group received a single intraperitoneal administration of mitomycin C at 2 mg/kg bw and were put down 24 hours following administration. The dose and time at which they were put down were based on the historical control data.
Examinations
- Tissues and cell types examined:
- micronuclei / bone-marrow smears
- Details of tissue and slide preparation:
- Preparation of bone-marrow smears
The mice that were alive at the completion of the treatment period were put down humanely by dislocating the neck bone. The right femur was removed and bone marrow cells were washed out using a small volume (0.5 to 1.0 mL/femur) of fetal bovine serum. The bone marrow cells were centrifuged at 1000 rpm for five minutes. The supernatant was removed and the bone marrow cells in the test tube were mixed well using a Pasteur pipette to prepare a suspension of even consistency. One drop of the suspension was placed on a slide, and a cover glass was used to prepare a bone-marrow smear. The smear was dried at room temperature, fixed using methanol for five minutes, and stained using Giemsa’s staining solution for 30 minutes. Next, the smear was washed with Sörensen phosphate buffer and placed in a 0.004% citric acid solution for several seconds. The smear was washed with distilled water and dried naturally. Two smears were prepared per mouse, and the code number was written on each smear.
Observation of micronuclei
The bone-marrow smear were observed using a 100× oil immersion objective lens and a 10× ocular lens (total: 1000×), and in the order of the code. Information on the test solution for each bone-marrow smear was concealed (blind observation). Erythrocytes were classified as either polychromatic erythrocytes (PCE) or normochromatic erythrocytes (NCE). One thousand PCE were observed per bone-marrow smear and the percentage of micronucleated PCE (MNPCE) was calculated. One thousand erythrocytes (PCE and NCE [total erythrocytes]) were observed per animal (smear) and the proportion of the PCE to total erythrocytes was calculated to examine the cytostatic effect of the test solution on erythroblasts. - Evaluation criteria:
- The percentages of MNPCE in the negative control group and the positive control group were compared with historical control data for the negative control. If the following criteria were met, this study was regarded as valid:
The number of MNPCE in the negative control group in this study does not exceed the number of MNPCE estimated on the basis of the historical control data.
The number of MNPCE in the positive control group in this study exceeds the number of MNPCE estimated on the basis of the historical control data. - Statistics:
- The test results were assessed using the Kastenbaum and Bowman assessment table. In addition, in order to examine the cytostatic effect of the test item on bone marrow cells, the proportions of PCE to total erythrocytes in the test item and positive control groups were each compared to that in the negative control group using Statistic Library 1, Statistical Analysis Version 5. When three or more groups were compared, the comparisons were carried out in the following manner. Bartlett’s test for homogeneity was conducted for distribution among the groups. If the distribution in the groups was equivalent, one-way analysis of variance (ANOVA) was carried out. If ANOVA revealed a significant difference among the groups, a Dunnett’s test was performed to compare the mean values of the negative control and the test article (or positive control) groups. If the distribution was not equivalent, a Kruskal-Wallis rank-test was performed. If the rank-test revealed a significant difference, a Dunnett’s test (a comparison of the mean values of the negative control and the test article or positive control groups) was performed.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test item was shown to inhibit the growth of erythroblasts at dose levels of >= 100 mg/kg bw, but does not have the potency of eliciting micronuclei in vivo.
- Executive summary:
An in vivo micronucleus study using the bone marrow of male CD-1 mice was conducted, where groups of 6 mice received doses of 400, 200, 100 or 50 mg/kg bw via intraperitoneal injections (twice with 24 -hour interval). The bone-marrow smears were prepared 24 hours following the final administration. Four deaths were observed in the 400 mg/kg bw group and one death in the 200 mg/kg bw group. A decrease in locomotor activity and bradypnea were observed at >= 50 mg/kg bw, piloerection was observed at >= 100 mg/kg bw and hypothermia, lacrimation and prone position at >= 200 mg/kg bw. A decrease in body weight was observed at >= 100 mg/kg bw one day following the first administration and onwards. The percentage of MNPCE in the MMC (positive control) group 24 hours following single intraperitoneal administration was 4.77%, which is clearly higher than that in the negative control group, 0.07%. The number of MNPCE was 286, which was assessed as positive and exceeded the number of MNPCE estimated on the basis of the historical control data. The number of MNPCE in the negative control group was within the range estimated on the basis of the historical control data. Thus, it was judged that this study was valid.
The percentage of MNPCE in the 400, 200, 100 and 50 mg/kg bw groups 24 hours following the final administration of the test item was 0.10, 0.08, 0.07 and 0.18%, respectively. These values were within the range estimated on the basis of the historical control data for the negative control. The result of the Kastenbaum and Bowman assessment was negative. The proportion of PCE to total erythrocytes was significantly lower in the 100 and 200 mg/kg bw groups than that in the negative control group.
Based on these results it can be concluded that the test item inhibits the growth of erythroblasts at >= 100 mg/kg bw, but does not have the potency of eliciting micronuclei in vivo.
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