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EC number: 251-156-3 | CAS number: 32687-78-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- 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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- 1000 instead of 2000 cells scored per animal
- Principles of method if other than guideline:
- Treatment consisted of one daily dose (gavage) of 1250, 2500 or 5000 mg/kg on each of two consecutive days. The animals were sacrificed 24 h after the second application. From the bone marrow smears were made and interphase cells were analyzed for nucleus anomalies resulting from chromosomal damage.
- GLP compliance:
- no
- Remarks:
- but QAU statment included.
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- EC Number:
- 251-156-3
- EC Name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- Cas Number:
- 32687-78-8
- Molecular formula:
- C34H52N2O4
- IUPAC Name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N'-[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]propanehydrazide
- Details on test material:
- - Physical state: white powder
- Analytical purity: 100%
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: random outbred strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Tierfarm, Sisseln
- Age at study initiation: 6-10 weeks (females), 4-9 weeks (males)
- Weight at study initiation: 20-27 g (females), 22-30 g (males)
- Housing: single housing
- Diet: Standard diet: NAFAG No.924, ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 49-60
- Photoperiod: 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Arachid oil (20 mL/kg bw)
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- Once daily for two consecutive days
- Post exposure period:
- 24 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide: 128 mg/kg bw in 20 ml/kg Arachid oil.
Examinations
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The oral LD50 was found to be >5000 mg/kg bw in Chinese hamsters of either sex (cf. Lab.Report: GU 2, dated March 15, 1983)
TREATMENT AND SAMPLING TIMES:
Single daily dosing of animals for 2 days. 24 h after last dosing, the bone marrow was prepared.
DETAILS OF SLIDE PREPARATION:
Bone marrow was harvested from the shafts of both femurs. In a siliconized pipette filled with approx. 0.5 mL rat serum the bone marrow was drawn up. In order to receive a homogeneous suspension the content of pipette was aspirated gently about three times. Small drops of the mixture were transferred on the end of a slide, spread out by pulling it behind a polished cover glass and the preparations were air-dried. Three hours later, the slides were stained in undiluted May-Gruenwald solution for 2 min then in May-Gruenwald solution/water 1/1 for 2 min and then in Giemsa's, 40% for 20 min. After being rinsed in methanol 55% for 5-8 sec and washed off twice in water, they were left immersed in water for approx. 2 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylol and mounted in Eukitt.
METHOD OF ANALYSIS:
The slides of three female and three male animals each of the negative control group, the positive control group and of the groups treated with various doses of test substance were examined microscopically. 1000 bone marrow cells each were scored per animal and the following anomalies were registered:
a) Single Jolly bodies, b) fragments of nuclei in erythrocytes, c) micronuclei in erythroblasts, d) micronuclei in leucopoietic cells, e) polyploid cells. - Evaluation criteria:
- Statistic significant difference of examined cell types in control and test group.
- Statistics:
- The significance of difference was assessed by CHI-Square test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In all dosage groups the percentage of cells displaying anomalies of nuclei did not differ significantly from the negative control. By contrast, the positive control (cyclophosphamide, 128 mg/kg bw) yielded a marked increase of the percentage of cells with anomalies. Here the mean percentage of anomalies was 7.2, whereas the negative control yielded a percentage of 0.17. The difference is highly significant (p<0.05).
Any other information on results incl. tables
Table 1: Percent of cells with anomalies of nuclei, 24 h after second application of test substance.
|
Number of animal |
Sex of animals |
Single Jolly-Bodies |
Fragments of nuclei in erythrocytes |
Micronuclei in erythroblasts |
Micronuclei in leucopoietic cells |
Polyploid cells |
Totals |
|
Vehicle control |
1 |
F |
0.2 |
|
|
|
|
0.2 |
|
|
2 |
F |
0.2 |
|
|
|
|
0.2 |
|
|
3 |
F |
0.1 |
|
|
|
|
0.1 |
|
|
4 |
M |
|
|
|
|
|
0.0 |
|
|
5 |
M |
0.2 |
|
|
|
|
0.2 |
|
|
6 |
M |
0.3 |
|
|
|
|
0.3 |
|
Cyclophosphamide, 128 mg/kg bw |
1 |
F |
7.7 |
0.3 |
1 |
0.3 |
|
9.3 |
|
|
2 |
F |
6.5 |
0.2 |
1.5 |
0.8 |
0.1 |
9.1 |
|
|
3 |
F |
7.9 |
0.7 |
0.3 |
0.1 |
|
9.0 |
|
|
4 |
M |
4.9 |
0.2 |
0.7 |
0.1 |
0.1 |
6.0 |
|
|
5 |
M |
3.9 |
|
0.4 |
0.4 |
|
4.7 |
|
|
6 |
M |
4.6 |
0.2 |
0.3 |
0.1 |
|
5.2 |
|
Test substance, 1250 mg/kg bw |
1 |
F |
|
|
|
|
0.0 |
||
|
2 |
F |
0.1 |
|
|
|
|
0.1 |
|
|
3 |
F |
0.1 |
|
|
|
|
0.1 |
|
|
4 |
M |
|
|
0.1 |
|
0.1 |
||
|
5 |
M |
|
|
|
|
0.0 |
||
|
6 |
M |
0.1 |
|
|
|
|
0.1 |
|
Test substance,2500 mg/kg bw | 1 | F | 0.1 | 0.1 | |||||
2 | F | 0.0 | |||||||
3 | F | 0.0 | |||||||
4 | M | 0.1 | 0.1 | ||||||
5 | M | 0.0 | |||||||
6 | M | 0.0 | |||||||
Test substance, 5000 mg/kg bw | 1 | F | 0.1 | 0.1 | |||||
2 | F | 0.0 | |||||||
3 | F | 0.2 | 0.2 | ||||||
4 | M | 0.0 | |||||||
5 | M | 0.1 | 0.1 | ||||||
6 | M | 0.1 | 0.1 |
Applicant's summary and conclusion
- Conclusions:
- The test substance did not show any genotoxic potential under the test conditions chosen.
- Executive summary:
The test article's clastogenic potential was determined in a nucleus anomaly test in Chinese hamsters. The test substance was administered by gavage to 6 male and female Chinese hamsters. Treatment consisted of one daily dose of 1250, 2500 or 5000 mg/kg bw on each of two consecutive days. The animals were sacrificed 24 h after the second application. From the bone marrow smears were made and interphase cells were observed for anomalies. In all dosage groups the percentage of cells displaying anomalies of nuclei did not differ significantly from the negative control. Thus, the test substance did not show any genotoxic potential under the test conditions chosen.
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