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EC number: 610-288-5 | CAS number: 462-20-4
- 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:
- 31.08.2000 - 10.10.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- Cas Number:
- 462-20-4
- Molecular formula:
- C8H16O2S2
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- EC Number:
- 610-288-5
- Cas Number:
- 462-20-4
- Molecular formula:
- C8H16O2S2
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Dihydrolipoic Acid
- Physical state: liquid
- Analytical purity: 96.3 % (HPLC)
- Lot/batch No.: 930001
- Storage condition of test material: room temperature, under nitrogen, in the dark
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Gene involved in histidine synthesis.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- n. a.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- n. a.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- Experiments I and II: 50; 150; 500; 1500; 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:The test item was dissolved in DMSO and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoantracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The test material may be considered positive in this test system if the following creiteria are met: The test material should have induced a reproducible, dose-related and statistically (see below) significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- The data were evaluated according to Dunnett's method of linear regression (Kirkland D J (Ed) (1989) Statistical Evaluation of Mutagenicity Test Data. UKEMS Subcommitee on Guidelines for Mutagenicity Testing, Report - Part III, Cambridge University Press.)
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
Any other information on results incl. tables
Table 1: Test Results of Experiment 1 (without and with metabolic activation).
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
- |
0 |
134 158 121 |
(138) 18.8# |
21 23 22 |
(22) 1.0 |
23 28 37 |
(29) 7.1 |
27 15 31 |
(24) 8.3 |
20 17 18 |
(18) 1.5 |
- |
50 |
116 132 134 |
(127) 9.9 |
19 25 32 |
(25) 6.5 |
26 22 33 |
(27) 5.6 |
22 26 20 |
(23) 3.1 |
14 25 24 |
(21) 6.1 |
- |
150 |
118 132 109 |
(120) 11.6 |
18 17 22 |
(19) 2.6 |
24 26 20 |
(23) 3.1 |
16 32 44 |
(31) 14.0 |
22 24 25 |
(24) 1.5 |
- |
500 |
119 132 131 |
(127) 7.2 |
15 23 9 |
(16) 7.0 |
28 29 41 |
(33) 7.2 |
37 31 38 |
(35) 3.8 |
16 28 25 |
(23) 6.2 |
- |
1500 |
103 134 121 |
(119) 15.6 |
14 21 29 |
(21) 7.5
|
17 19 20 |
(19) 1.5 |
25 19 24 |
(23) 3.2 |
20 24 16 |
(20) 4.0 |
- |
5000 |
80 110 128 |
(106) 24.2 |
21 13 26 |
(20) 6.6 |
22 17 28 |
(22) 5.5 |
18S 18S 12S |
(16) 3.5 |
11 12 12 |
(12) 0.6 |
Positive controls |
Name Concentration (µg/plate) |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 |
5 |
2 |
0.2 |
80 |
|||||||
S9-Mix - |
No. colonies per plate |
430 483 390 |
(434) 46.7 |
261 163 181 |
(202) 52.2 |
541 580 488 |
(536) 46.2 |
93 145 177 |
(138) 42.4 |
1408 1119 1083 |
(1203) 178.2 |
|
|
|
|
|
|
|
|
|
|
|
|
+ |
0 |
135 130 131 |
(132) 2.6# |
20 15 12 |
(16) 4.0 |
41 34 28 |
(34) 6.5 |
39 44 30 |
(38) 7.1 |
21 22 21 |
(21) 0.6 |
+ |
50 |
129 145 162 |
(145) 16.5 |
11 20 19 |
(17) 4.9 |
33 24 28 |
(28) 4.5 |
47 36 42 |
(42) 5.5 |
16 24 18 |
(19) 4.2 |
+ |
150 |
134 144 144 |
(141) 5.8 |
22 19 22 |
(21) 1.7 |
25 22 34 |
(27) 6.2 |
40 31 40 |
(37) 5.2 |
21 21 17 |
(20) 2.3 |
+ |
500 |
126 141 149 |
(139) 11.7 |
22 23 20 |
(22) 1.5 |
25 21 24 |
(23) 2.1 |
31 34 59 |
(41) 15.4 |
15 21 22 |
(19) 3.8 |
+ |
1500 |
119 157 116 |
(131) 22.9 |
14 12 11 |
(12) 1.5 |
30 29 27 |
(29) 1.5 |
38 39 39 |
(39) 0.6 |
25 14 18 |
(19) 5.6 |
+ |
5000 |
102 106 81 |
(96) 13.4 |
4S 11S 5S |
(7) 3.8 |
19 16 22 |
(19) 3.0 |
26 21 28 |
(25) 3.6 |
17 23 13 |
(18) 5.0 |
Positive controls |
Name Concentration (µg/plate) |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
S9-Mix + |
No. colonies per plate |
1 |
2 |
10 |
5 |
2 |
|||||
1983 1902 1988 |
(1958) 48.3 |
325 246 265 |
(279) 41.2 |
957 740 942 |
(880) 121.2 |
177 173 166 |
(172) 5.6 |
482 414 473 |
(456) 36.9 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4 -Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
2AA: 2-Aminoanthracene
BP: Benzo(a)pyrene
S: Sparse bacterial background lawn
#: Standard deviation
Table 2: Test Result of Experiment 2 (without and with metabolic activation).
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
- |
0 |
C 97 99 |
(98) 1.4# |
22 24 22 |
(23) 1.2 |
24 29 31 |
(28) 3.6 |
22 32 17 |
(24) 7.6 |
22 18 26 |
(22) 4.0 |
- |
50 |
102 96 94 |
(97) 4.2 |
18 18 21 |
(19) 1.7 |
21 26 27 |
(25) 3.2 |
22 21 21 |
(21) 0.6 |
13 16 14 |
(14) 1.5 |
- |
150 |
88 112 92 |
(97) 12.9 |
17 8 15 |
(13) 4.7 |
17 15 19 |
(17) 2.0 |
24 19 22 |
(22) 2.5 |
22 20 28 |
(23) 4.2 |
- |
500 |
88 98 106 |
(97) 9.0 |
21 20 22 |
(21) 1.0 |
23 21 24 |
(23) 1.5 |
23 29 22 |
(25) 3.8 |
20 21 25 |
(22) 2.6 |
- |
1500 |
71 77 81 |
(76) 5.0 |
17 18 11 |
(15) 3.8 |
25 36 22 |
(28) 7.4 |
18 31 22 |
(24) 6.7 |
17 19 21 |
(19) 2.0 |
- |
5000 |
70 48 62 |
(60) 11.1 |
14 20 19 |
(18) 3.2 |
25 28 16 |
(23) 6.2 |
30 21 22 |
(24) 4.9 |
8 10 12 |
(10) 2.0 |
Positive controls |
Name Concentration (µg/plate) |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 |
5 |
2 |
0.2 |
80 |
|||||||
S9-Mix - |
No. colonies per plate |
430 440 413 |
(428) 13.7 |
128 101 156 |
(128) 27.5 |
623 637 579 |
(613) 30.3 |
79 98 103 |
(93) 12.7 |
1018 912 1008 |
(979) 58.5 |
|
|
|
|
|
|
|
|
|
|
|
|
+ |
0 |
119 102 107 |
(109) 8.7# |
19 17 19 |
(18) 1.2 |
31 37 29 |
(32) 4.2 |
39 36 44 |
(40) 4.0 |
21 25 19 |
(22) 3.1 |
+ |
50 |
118 104 108 |
(110) 7.2 |
20 22 25 |
(22) 2.5 |
31 23 38 |
(31) 7.5 |
34 38 32 |
(35) 3.1 |
25 22 17 |
(21) 4.0 |
+ |
150 |
126 103 113 |
(114) 11.5 |
11 12 17 |
(13) 3.2 |
22 29 22 |
(24) 4.0 |
42 32 35 |
(36) 5.1 |
27 20 14 |
(20) 6.5 |
+ |
500 |
96 144 102 |
(114) 26.2 |
9 9 13 |
(10) 2.3 |
30 25 16 |
(24) 7.1 |
37 35 32 |
(35) 2.5 |
23 17 24 |
(21) 3.8 |
+ |
1500 |
104 107 101 |
(104) 3.0 |
29 17 18 |
(21) 6.7 |
23 30 39 |
(31) 8.0 |
33 29 30 |
(31) 2.1
|
23 14 17 |
(18) 4.6 |
+ |
5000 |
94 103 78 |
(92) 12.7 |
6 10 12 |
(9) 3.1 |
25 36 19 |
(27) 8.6 |
21 29 30 |
(27) 4.9 |
19 12 11 |
(14) 4.4 |
Positive controls |
Name Concentration (µg/plate) |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
S9-Mix + |
No. colonies per plate |
1 |
2 |
10 |
5 |
2 |
|||||
1026 850 1018 |
(965) 99.4 |
201 158 192 |
(184) 22.7 |
479 493 434 |
(469) 30.8 |
395 413 331 |
(380) 43.1 |
392 433 492 |
(439) 50.3 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4 NQO: 4-Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
2AA: 2 -Aminoanthracene
BP: Benzo(a)pyrene
C: Contaminated
#: Standard deviation
Applicant's summary and conclusion
- Executive summary:
In a study according to OECD 471 and EU Method B.14 the Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and the Escherichia coli strain WP2uvrA- were treated with suspensions of Dihydrolipoic Acid using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10 % liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate in the first experiment. The experiment was repeated using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations.
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay of the S9-mix were validated.
The test material caused eighter an intermittet but visible reduction in the growth of the bacterial backround lawn and/or a significant decrease in the frequency of revertant colonies in the majority of the tester strains, both with and without metabolic activation at 5000 µg/plate. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. No test material precipitate was observed on the plates at any of the doses tested in eighter the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, eighter with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
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