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EC number: 245-442-7 | CAS number: 23128-74-7
- 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 cell study: DNA damage and/or repair
- 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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.5915 (In Vivo Sister Chromatid Exchange Assay)
- Version / remarks:
- (1998)
- Deviations:
- yes
- Remarks:
- (4 animals per sex and dose)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.5915 (In Vivo Sister Chromatid Exchange Assay)
- Deviations:
- yes
- Remarks:
- (4 animals per sex and dose)
- Principles of method if other than guideline:
- Procedure according to Perry et al. (1974), Goto et al. (1978), Allen et al. (1977), Perry et al. (1975), Marquardt et al. (1978)
PERRY, P. and S. WOLFF Nature 251 , 156-158 (1974).
GOTO, K., S. MAEDA, Y. KANO and T. SUGIYAMA Chromosoma (Berl.) 66, 351-359 (1978).
ALLEN, J.W., C F . SHULER, R.W. MENDES and S.A. LATT
Cytogenet. Cell Genet. 18, 231-237 (1977).
PERRY, P. and H.J. EVANS Nature 258, 121-125 (1975).
MARQUARDT, H. and U. BAYER Mutation Res. 56, 169-176 (1978). - GLP compliance:
- no
- Type of assay:
- sister chromatid exchange assay
Test material
- Reference substance name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
- EC Number:
- 245-442-7
- EC Name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
- Cas Number:
- 23128-74-7
- Molecular formula:
- C40H64N2O4
- IUPAC Name:
- N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]
- Details on test material:
- - Physical state: solid
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: 20-28 g (females), 25-30 g (males)
- Diet (e.g. ad libitum): NAFAG No. 924
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22- 24
- Humidity (%): 54-62
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.7% aqueous solution of CMC (carboxymethyl cellulose)
- Amount of vehicle (if gavage or dermal): 20 mL/kg bw - Details on exposure:
- Two hrs before application of test or control substance each animal is applied with 5 -bromodeoxyuridine (BUdR) (45 mg tab as subcutaneous implantation in the neck (Fa. Heinrich Mack, D-Illertissen, Germany)). Twenty-four hours after administration of test substance and 2hrs after intraperitoneal injection with colcemide animals were sacrificed.
- Duration of treatment / exposure:
- 24 hrs
- Frequency of treatment:
- single dose
- Post exposure period:
- 24 hrs (test substance)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 3 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 6 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 4 (only chromatides of 2 animals per group and sex examined)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 7,12-dimethylbenzanthracene
- Route of administration: oral, gavage
- Doses / concentrations: 100 mg/kg bw in 0.7% aqueous solution of sodium-carboxymethylcellulose (CMC)
Examinations
- Tissues and cell types examined:
- Bone marrow, 25 cells per animal in metaphase
- Details of tissue and slide preparation:
- Bone marrow from the shafts of both femurs was suspended in balanced salt solution and diluted to hypotonicity with distilled water, kept in a waterbath at 4 to 6°C for 23 min and then centrifuged for 10 min at 200 x g. The pellets were then fixed in methanol-acetic acid 3:1 for a period of 30 min, resuspended, centrifuged for 5 min at 150 x g, and stored in renewed fixative overnight at 4°C. Finally the pellets again were centrifuged for 5 min at 150 x g, and resuspended in some 0.5 mL fixative.
These specimens were pipetted onto wet slides and air-dried. The air-dried slides then were treated with a solution of bisbenzimide for 15 min, rinsed in McIlvaine-buffer pH 8.0 and irradiated in this buffer at 50°C with UV-light of 350 nm. Following the development of the fluorochrome-UV-light reaction in 60°C 2 x SSC (standard sodium citrate) for 90 min, the slides were stained in 40% Giemsa for 20-40 min, well rinsed, cleared in Xylol and mounted in Eukitt.
The slides of two female and two male animals each of the treatment groups and of the control groups were examined. Twenty-five differently stained metaphases of the second cell-cycle with 5-bromodeoxyuridine (BUdR)-substitution were analysed. - Evaluation criteria:
- Analyze of Sister Chromatide Exchanges (SCE's) according to Marquardt et al. (1978)
MARQUARDT, H. and BAYER, U. Mutation Res. 56, 169-176 (1978). - Statistics:
- Significance of differences between treatment and control group was assessed by the t-test (p < 0.01)
Results and discussion
Test results
- 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:
- When comparing the number of SCE’s between negative control and the test groups (1500, 3000 and 6000 mg/kg bw test substance) no statistical difference between treated groups and control could be seen. In contrast, the positive control group showed a highly significant increase of SCE's per cell (12.8) in comparison with the negative control (5.28 SCE's/cell).
Any other information on results incl. tables
Table 1: The effect of test substance on bone marrow cells of chinese hamster
Group |
Dose [mg/kg] |
overall no of animals |
group mean no. |
standard- |
t-value |
Control (0.7% CMC in water) |
|
2m +2f |
5.28 |
2.95 |
|
Control (DMBA) |
100 |
2m +2f |
12.79 |
6.25 |
10.88* |
Test substance |
1500 |
2m +2f |
6.02 |
3.16 |
1.72 |
Test substance |
3000 |
2m +2f |
4.81 |
2.37 |
1.24 |
Test substance |
6000 |
2m +2f |
4.88 |
3.91 |
0.82 |
* p≤ 0.01 DMBA= 7,12 Dimethylbenzanthracene |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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