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EC number: 253-039-2 | CAS number: 36443-68-2
- 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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
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
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- EC Number:
- 253-039-2
- EC Name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- Cas Number:
- 36443-68-2
- Molecular formula:
- C34H50O8
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Females weighed 21-28 g and males weighed 21-30 g.
- Housing: Individual caging.
- Diet (e.g. ad libitum): Standard diet (NAFAG No.924) ad libitum.
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23 °C.
- Humidity (%): 54-57%.
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose) plus Tween 80.
- Amount of vehicle (if gavage or dermal): 20 mL CMC plus Tween 80/kg body weight.
- Vehicle(s)/solvent(s) used: Sodium CMC (carboxymethyl cellulose) plus Tween 80.
- Concentration of test material in vehicle: 750, 1,500, and 3,000 mg/kg body weight in 20 mL/kg body weight of 0.5% aqueous solution of sodium CMC containing 0.1% Tween 80. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: No details.
- Duration of treatment / exposure:
- The preparation was administered orally to groups of 6 female and 6 male animals each. Treatment consisted of daily one gavage administration on 2 consecutive days.
- Frequency of treatment:
- Once/day.
- Post exposure period:
- 24 h after the second application, the animals were sacrificed by dislocation of the cervical vertebrae.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 3 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6 Males and 6 females.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: Oral (gavage).
- Doses/concentrations: 128 mg/kg body weight in 20 mL/kg body weight.
Examinations
- Tissues and cell types examined:
- Bone marrow was harvested from the shafts of both femurs.
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
In a siliconized pipette filled with approx. 0.5 µL rat serum the bone marrow was drawn up. In order to receive a homogeneous suspension the content of pipette was aspirated gently about 3 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. 3 Hours later, the slides were stained in undiluted May-Grünwald solution for 2 minutes then in May-Grünwald solution:water 1:1 for 2 minutes and then in Giemsa's (40%) for 20 minutes. After being rinsed in methanol (55%) for 5-8 seconds and washed off twice in water, they were left immersed in water for approximately 2 minutes. After rinsing with distilled water and air-drying, the slides were cleared in Xylol and mounted in Eukitt. - Evaluation criteria:
- The slides of 3 female and 3 male animals each of the negative control group, the positive control group and of the groups treated with various dose were examined. 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; and
e) polyploid cells. - Statistics:
- The significance of difference was assessed by chi-square test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- 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 body weight) yielded a marked increase of the percentage of cells with anomalies. Here the mean percentage of anomalies was 9.68, whereas the negative control yielded a percentage of 0.10. The difference is highly significant (p<0.05).
Any other information on results incl. tables
EXPERIMENTAL RESULTS
percent of cells with anomalies of nuclei | ||||||||
number of animal | sex of animal | single jolly bodies | frasgments of nuclei in erythrocytes | micronuclei in erythroblasts | micronuclei in leucopoietic cells | polyploid cells | total | |
Control (0.5% CMC + 0.1% Tween 80) |
1 | f | 0.1 | 0.1 | ||||
2 | f | 0.1 | 0.1 | |||||
3 | f | 0.2 | 0.1 | 0.3 | ||||
4 | m | 0.0 | ||||||
5 | m | 0.0 | ||||||
6 | m | 0.1 | 0.1 | |||||
Cyclophosphamide (128 mg/kg) |
1 | f | 5.5 | 0.9 | 2.1 | 0.6 | 9.1 | |
2 | f | 10.9 | 1.7 | 1.7 | 0.4 | 14.7 | ||
3 | f | 6.0 | 0.2 | 2.4 | 0.1 | 0.1 | 8.8 | |
4 | m | 5.1 | 0.6 | 0.8 | 0.2 | 6.7 | ||
5 | m | 5.7 | 1.6 | 1.4 | 0.3 | 0.1 | 9.1 | |
6 | m | 8.2 | 0.9 | 0.2 | 0.4 | 9.7 | ||
test article (750 mg/kg) | 1 | f | 0.0 | |||||
2 | f | 0.2 | 0.2 | |||||
3 | f | 0.2 | 0.2 | |||||
4 | m | 0.2 | 0.2 | |||||
5 | m | 0.0 | ||||||
6 | m | 0.0 | ||||||
test article (1500 mg/kg) | 1 | f | 0.1 | 0.1 | ||||
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 article (3000 mg/kg) | 1 | f | 0.1 | 0.1 | ||||
2 | f | 0.2 | 0.1 | 0.1 | 0.4 | |||
3 | f | 0.1 | 0.1 | 0.2 | ||||
4 | m | 0.0 | ||||||
5 | m | 0.0 | ||||||
6 | m | 0.1 | 0.1 |
Applicant's summary and conclusion
- Conclusions:
- It was concluded that, under the conditions of this experiment, no evidence of mutagenic effects were noted in Chinese hamsters treated with the test substance.
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