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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1983-03-26)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation 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]
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 98: rfa-, uvrB-, R-factor; TA 100: rfa-, uvrB-, R-factor; TA 1535: rfa-, uvrB-; TA 1537: rfa-, uvrB
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix) prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity test: concentrations ranging from 0.08 to 5000 µg/plate.
First test (with and without microsomal activation) 20, 78, 313, 1250, 5000 µg/plate
Second test (with and without microsomal activation): 500, 1000, 2000, 40000, 8000 µg/plate - Vehicle / solvent:
- ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: for details see below
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hrs
NUMBER OF REPLICATIONS: triplicates per strain and dose each in 2 independent experiments
POSITIVE CONTROLS:
Without S9 mix:
TA 98: daunorubicin-HCl, 5 and 10 µg/0.1 ml phosphate buffer;
TA 100: 4-nitroquinoline-N-oxide, 0.125 and 0.25 µg/0.1 ml phosphate buffer
TA 1535: sodium azide, 2.5 and 5.0 µg/0.1 ml bidistilled water
TA 1537: 9(5)-aminoacridine hydrochloride monohydrate, 50 and 100 µg/0.1 ml dimethylsulfoxide
With S9 mix:
TA 98, TA 100 and TA 1537: 2-aminoanthracene, 5 µg/0.1 ml dimethylsulfoxide
TA 1535: cyclophosphamide, 250 µg/0.1 ml bidistilled water - Evaluation criteria:
- A substance is to be considered as mutagenic when one or both of the following criteria are fulfilled:
1.) doubling of spontaneous mutation rate for strains TA 98, TA 1535 and TA 1537
2.) a mutation rate of at least 1.5 for strain TA 100
a dose response-relationship should be demonstrable
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At concentrations of 313 µg/plate and above substance precipitates in soft agar
RANGE-FINDING/SCREENING STUDIES:
- 5000 µg/plate was selected at highest dose from cytotoxicity experiments. Up to 5000 µg/plate no cyctotoxic effect was seen in pretest - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of plate incorporation test (test 1) with and without metabolic activation
|
Plate Incorporation test 1 |
|||||
Substance |
With/ or without |
Test substance |
Mean number of revertant colonies per plate |
|||
|
|
|
Salmonella typhymurium |
|||
|
|
|
Base-pair substitution type |
Frameshift type |
||
|
|
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
vehicle only |
- |
0 |
16 |
116 |
4 |
31 |
test substance |
- |
20 |
13 |
99 |
6 |
33 |
test substance |
- |
78 |
13 |
103 |
4 |
28 |
test substance |
- |
313 |
11 |
107 |
5 |
29 |
test substance |
- |
1250 |
18 |
99 |
5 |
26 |
test substance |
- |
5000 |
11 |
85 |
6 |
19 |
|
|
|
|
|
|
|
Sodium Azide |
- |
2.5 |
548 |
|
|
|
Sodium Azide |
|
5 |
788 |
|
|
|
Daunorubicin |
- |
5 |
|
|
|
536 |
Daunorubicin |
|
10 |
|
|
|
189 |
4-Nitroquinoline- |
- |
0.125 |
|
593 |
|
|
4-Nitroquinoline- |
|
0.25 |
|
1000 |
|
|
9-Aminoacridine- |
- |
50 |
|
|
110 |
|
9-Aminoacridine- |
- |
100 |
|
|
977 |
|
|
|
|
|
|
|
|
vehicle only |
+ |
0 |
25 |
110 |
14 |
42 |
test substance |
+ |
20 |
16 |
115 |
15 |
57 |
test substance |
+ |
78 |
34 |
120 |
15 |
60 |
test substance |
+ |
313 |
25 |
106 |
12 |
44 |
test substance |
+ |
1250 |
28 |
127 |
12 |
63 |
test substance |
+ |
5000 |
20 |
119 |
15 |
47 |
Cylophosphamide |
+ |
250 |
597 |
|
|
|
2-Aminoanthracene |
|
606 |
161 |
1250 |
Table 2: Results of plate- incorporation test with and without metabolic activation
|
Plate Incorporation test 2 |
|||||
Substance |
With/ or without |
Test substance |
Mean number of revertant colonies per plate |
|||
|
|
|
Salmonella typhymurium |
|||
|
|
|
Base-pair substitution type |
Frameshift type |
||
|
|
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
vehicle |
- |
0 |
18 |
135 |
9 |
27 |
test substance |
- |
500 |
14 |
109 |
7 |
29 |
test substance |
- |
1000 |
13 |
129 |
5 |
26 |
test substance |
- |
2000 |
12 |
132 |
6 |
26 |
test substance |
- |
4000 |
22 |
118 |
7 |
24 |
test substance |
- |
8000 |
16 |
105 |
9 |
22 |
Sodium Azide |
- |
2.5 |
461 |
|
|
|
Sodium Azide |
- |
5 |
699 |
|
|
|
4-Nitroquinoline- |
- |
0.125 |
|
683 |
|
|
4-Nitroquinoline- |
- |
0.25 |
|
1184 |
|
|
9-Aminoacridine- |
- |
50 |
|
|
1553 |
|
9-Aminoacridine- |
- |
100 |
|
|
2608 |
|
Daunorubicin- |
- |
5 |
|
|
|
160 |
|
|
|
|
|
|
|
vehicle |
+ |
0 |
20 |
145 |
19 |
45 |
test substance |
+ |
500 |
16 |
127 |
17 |
42 |
test substance |
+ |
1000 |
20 |
113 |
20 |
40 |
test substance |
+ |
2000 |
18 |
123 |
19 |
34 |
test substance |
+ |
4000 |
19 |
117 |
20 |
41 |
test substance |
+ |
8000 |
25 |
96 |
20 |
54 |
2-Aminoanthracene |
+ |
5 |
|
586 |
165 |
1171 |
Cyclophosphamid |
|
250 |
983 |
|
|
|
Applicant's summary and conclusion
- Executive summary:
A test of bacterial gene mutagenicity for the substance following the OECD guideline 471(1983) was conducted. Following strains were tested: TA 98, TA 100, TA 1535 and TA 1537. Test concentrations ranged from 20 to 8000 μg/ plate. Two experiments were conducted both in absence and presence of S9-mix. For the first experiment, the test concentration ranged from 20 to 5000 µg/plate. For the second experiment, the test concentration was in the range of 500 to 8000 µg/plate. No increase in revertant colonies was noticed, thus the test substance did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used with or without metabolic activation. Consequently the substance is considered to be nonmutagenic in this bacterial reverse mutation assay.
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