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EC number: 224-166-0 | CAS number: 4221-80-1
- 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
- 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:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- other: micronucleus assay
Test material
- Reference substance name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- EC Number:
- 224-166-0
- EC Name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- Cas Number:
- 4221-80-1
- Molecular formula:
- C29H42O3
- IUPAC Name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Cricetulus griseus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Kept in an air-conditioned room
- Diet (e.g. ad libitum): NAFAG No. 196
- Water: Tap water ad libitum.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature: 23 °C +/- 1 °C
- Humidity: 55 % +/- 5 %
- Photoperiod: The room was illuminated for 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: Sesame oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The preparation was administered orally to groups of 6 female and 6 male animals each.
- Test substance: 500, 1000 and 2000 mg/kg in 20 mL/kg sesame oil.
- Cyclophosphamide (ENDOXAN ): 128 mg/kg in 20 mL/kg sesame oil (positive control).
- 20 mL sesame oil/kg (negative control).
DIET PREPARATION
- Rate of preparation of diet (frequency): daily one application on 2 consecutive days - Duration of treatment / exposure:
- 48 hours
- Frequency of treatment:
- daily one application on 2 consecutive days
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Positive control(s):
- - Cyclophosphomamide
- Route of administration: orally
- Doses / concentrations: 128 mg/kg
Examinations
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES:
Treatment consisted of daily one application on 2 consecutive days. 24 h after the second application the animals were sacrificed.
DETAILS OF SLIDE PREPARATION:
Bone marrow was harvested from the shafts of both femurs. In a siliconized pipette filled with 0.5 yl 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. At the next day the slides were stained in undiluted May-Grunwald solution for 2 min then in May-Griinwald 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 are left immersed in water for approx. 2 min. After rinsing with distilled water and airdrying the slides were cleared in Xylol and mounted in Eukitt.
METHOD OF ANALYSIS:
The slides of three female and three male animals per group were examined. 1000 bone marrow cells each were scored per animal and the following anomalies were registered: Single Jolly bodies, fragments of nuclei in erythrocytes, micronuclei in erythroblasts, micronuclei in leucopoietic cells, polyploid cells. - Statistics:
- The significance of difference was assessed by X^2 test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- 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) yielded a marked increase of -the percentage of cells with anomalies. Here the mean percentage of anomalies was 5.17, whereas the negative control yielded a percentage of 0.083. The difference is highly significant (p<0.05).
Any other information on results incl. tables
|
Number of animals |
Sex of animals |
Single Jolly bodies |
Fragments of nuclei |
Micronuclei in |
Micronuclei in |
Polyploid cells |
Total |
Control |
1 |
f |
|
|
|
|
|
0.0 |
(Sesame oil) |
2 |
f |
0.2 |
|
|
|
|
0.2 |
|
3 |
f |
|
|
|
|
|
0.0 |
|
4 |
m |
0.1 |
|
|
|
|
0.1 |
|
5 |
m |
|
|
|
|
0.1 |
0.1 |
|
6 |
m |
|
|
|
|
0.1 |
0.1 |
Cyclophosphamide |
1 |
f |
4.8 |
1.1 |
0.1 |
0.1 |
0.3 |
6.4 |
(128 mg/kg) |
2 |
f |
3.7 |
0.8 |
0.2 |
|
0.3 |
5.0 |
|
3 |
f |
2.9 |
0.4 |
0.3 |
0.1 |
0.2 |
3.9 |
|
4 |
m |
3.3 |
0.6 |
0.2 |
0.1 |
0.4 |
4.6 |
|
5 |
m |
1.8 |
0.1 |
0.1 |
|
1.7 |
3.7 |
6 |
m |
4.3 |
2.2 |
0.3 |
0.2 |
0.4 |
7.4 |
|
Test item |
1 |
f |
0.2 |
|
|
|
|
0.2 |
(500 mg/kg) |
2 |
f |
|
|
|
|
0.1 |
0.1 |
|
3 |
f |
|
|
|
|
0.1 |
0.1 |
|
4 |
m |
|
|
|
|
|
0.0 |
|
5 |
m |
0.1 |
|
|
|
|
0.1 |
Test item |
6 |
m |
|
|
|
|
|
0.0 |
(1000 mg/kg) |
1 |
f |
|
|
|
|
0.2 |
0.2 |
|
2 |
f |
|
|
|
0.1 |
0.1 |
0.2 |
|
3 |
f |
0.3 |
|
|
|
0.1 |
0.4 |
|
4 |
m |
|
|
|
|
0.1 |
0.1 |
|
5 |
m |
|
|
|
|
|
0.0 |
|
6 |
m |
|
|
|
|
|
0.0 |
Test item |
1 |
f |
0.3 |
|
|
|
|
0.3 |
(2000 mg/kg) |
2 |
f |
0.1 |
|
|
|
|
0.1 |
|
3 |
f |
0.1 |
|
|
|
0.1 |
0.2 |
|
4 |
m |
|
|
|
|
0.2 |
0.2 |
|
5 |
m |
0.1 |
|
|
|
|
0.1 |
|
6 |
m |
|
|
|
|
|
0.0 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with preparations of the test article.
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