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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- 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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- , strain TA102 or E. coli is lacking (OECD TG 471, adopted 1997)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation 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
Constituent 1
Method
- Target gene:
- HIS
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from Aroclor1254-induced rats
- Test concentrations with justification for top dose:
- 25, 75, 225, 675 and 2025 µg per plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see details on test system and conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Each Petri dish contained: 1) approx. 20 mL of minimum agar (Agar, Difco Laboratories, Detroit, Michigan, U.S.A., plus salts (Vogel-Bonner Medium E) and glucose), 2) 0.1 mL of the solution of the test substance or the vehicle and 0.1 mL of a bacterial culture (in nutrient broth, Difco Laboratories, Detroit, Michigan, U.S.A., 0.8% plus 0.5% NaCl) in 2.0 mL of soft agar. The soft agar was composed of: 100 mL of 0.6% agar solution with 0.6% NaCl and 10 mL of a solution of l-histidine, 0.5 mM (Fluka, Buchs, Switzerland) and +biotin 0.5 mM (Fluka, Buchs, Switzerland). In the experiments in which the substance was metabolically activated, 0.5 mL of an activation mixture was added also. One mL activation mixture contained: 0.3 mL S9 fraction of liver from rats induced with Aroclor 1254 (Analabs., Inc., North Haven, Connecticut, U.S.A.) and 0.7 mL of a solution of co-factors.
DURATION
The plates were incubated for about 48 hours at 37°C in darkness.
NUMBER OF REPLICATIONS
3 plates per dose
DETERMINATION OF CYTOTOXICITY
No data
POSITIVE CONTROLS
TA 98: daunorubicin-HCl (5 and 10 µg/plate)
TA 100: 4-nitroquinoline-N-oxide (0.125 and 0.25 µg/plate)
TA 1535: N-Methyl-N'-nitro-N-nitrosoguanidine (3 and 5 µg/plate)
TA 1537: 9(5)aminoacridine hydrochloride monohydrate (50 and 100 µg/plate)
TA 1538: 2-nitrofluorene (5 and 10 µg/plate)
The activation mixture was tested with Strain TA 1535 and cyclophosphamide (250 µg/plate) - Evaluation criteria:
- When the colonies had been counted, the arithmetic mean was calculated. The test substance is generally considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 675 and 2025 µg/plate the substance precipitated in soft agar - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Number (arithmetic mean) of colonies of histidine-prototrophic back-mutants in experiments without microsomal activation.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
0 |
11 |
136 |
8 |
4 |
12 |
25 |
20 |
129 |
10 |
3 |
8 |
75 |
18 |
158 |
10 |
7 |
11 |
225 |
13 |
145 |
10 |
6 |
6 |
675 |
16 |
156 |
7 |
2 |
12 |
2025 |
17 |
159 |
7 |
6 |
9 |
Daunorubicin-HCl |
19 (control) |
|
|
|
|
5 |
134 |
|
|
|
|
10 |
293 |
|
|
|
|
4-NQO |
|
156 (control) |
|
|
|
0.125 |
|
650 |
|
|
|
0.250 |
|
>1000 |
|
|
|
N-methyl-N´-nitro-N-nitrosoguanidine |
|
|
8 (control) |
|
|
3 |
|
|
349 |
|
|
5 |
|
|
1470 |
|
|
9(5) Aminoacridine-HCl |
|
|
|
6 (control) |
|
50 |
|
|
|
85 |
|
100 |
|
|
|
520 |
|
2-Nitrofluorene |
|
|
|
|
11 (control) |
5 |
|
|
|
|
660 |
10 |
|
|
|
|
823 |
Table 2: Number (arithmetic mean) of colonies of histidine-prototrophic back-mutants in experiments with microsomal activation.
Concentration (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
0 |
26 |
141 |
4 |
3 |
15 |
25 |
24 |
136 |
7 |
4 |
15 |
75 |
21 |
141 |
12 |
5 |
19 |
225 |
26 |
128 |
7 |
5 |
16 |
675 |
24 |
112 |
7 |
3 |
16 |
2025 |
21 |
130 |
8 |
5 |
17 |
Cyclophosphamide |
|
|
|
|
|
0 |
|
|
13 |
|
|
250 |
|
|
214 |
|
|
Applicant's summary and conclusion
- Conclusions:
- The test substance showed no mutagenic potential in bacterial cells.
- Executive summary:
The mutagenic potential of the test material was assessed in an Ames assay with TA98, TA100, TA1535, TA1537 and TA1538 as tester strains. The bacteria were treated with 25, 75, 225, 675, and 2025 µg test substance per plate, with and without microsomal activation. Adequate positive controls and a solvent control were also applied. In the experiments performed with and without microsomal activation, comparison of the number of histidine-prototrophic mutants in the controls and after treatment with the test substance revealed no marked differences. The slight increase in the number of back-mutant colonies in the experiment on Strain TA 1535 with microsomal activation is attributed to variations in the rate of spontaneously occurring back-mutants.
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