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EC number: 206-696-4 | CAS number: 367-51-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The weight of evidence suggests that NaTG is not genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine reversion
- Species / strain / cell type:
- S. typhimurium, other: Strains: TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat and hamster liver S9 induced with aroclor 1254
- Test concentrations with justification for top dose:
- 0, 10, 33, 100, 333 and 1000 µg/plate
- Vehicle / solvent:
- no data
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without activation : sodium azide (TA1535 and TA 100), 9-aminoacridine (TA 97), 4-nitro-o-phenylenediamine (TA98). With activation : 2-aminoanthracene (all strains).
- Details on test system and experimental conditions:
- In the Salmonella assay, a test tube containing a suspension of one strain of Salmonella typhimurium plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are also prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated for 48 hours and then counted. The substance was tested initially in a toxicity assay to determine the appropriate dose range.
The toxicity assay was performed by using TA 100. Toxic concentrations were those at which a decrease in the number of his+ colonies was seen or at which there was a clearing in the density of the background lawn.
- Test Design . Number of replicates : 3
- Description of follow up repeat study : same conditions than the initial experiment performed 1 week later - Evaluation criteria:
- The positive control plates are counted, and the number of mutant colonies appearing on them must be significantly increased over the spontaneous control number for the test to be considered valid. If no increase in mutant colonies is seen after testing several strains under several different culture conditions, the test chemical is considered to be non mutagenic in the Salmonella test.
- Statistics:
- None
- Species / strain:
- S. typhimurium, other: Strains: TA98, TA100, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Under these experimental conditions, sodium thioglycolate is considered as non-genotoxic
- Executive summary:
In a study performed according to the US NTP protocol, four S. typhimurium strains (TA 98, TA 100, TA 1535 and TA 1537) were exposed to sodium thioglycolate in a preincubation assay. Based on a preliminary toxicity assay, concentrations up to 1000 µg/plate were used with or without metabolic activation (rat and hamster S9) in all four strains. Sodium thioglycolate did not induce mutations in these studies. Positive and solvent controls gave the expected results.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- The read-across is a category approach based on the hypothesis that compounds in this category are transformed to a common compound. This approach serves to use existing data on genotoxicity, repeated-dose toxicity, and reproductive toxicity endpoints for substances in this category.
There are no relevant variations in properties among source substances and the same potency is predicted for all target substances. This is Scenario 5 of the RAAF11 . Substances ATG, MEATG, KTG, CaTG, and NaTG are different inorganic salts of a common acid, thioglycolic acid (TGA; synonym: 2- mercaptoacetic acid). They dissociate rapidly in aqueous media, e.g., the test organism, to the common thioglycolate anion and to their different counter ions (Figure 1). The water solubility of all category members is high, except for CaTG which is only moderately soluble in water.
In the repeated-dose toxicity studies with NaTG, specific toxicity is exerted via the well-investigated inhibition of mitochondrial fatty acid beta-oxidation by the thioglycolate (2-mercaptoacetate) anion 2,3,4. Inhibition of beta-oxidation leads to increased triglycerides and decreased acetyl-CoA in liver, and subsequently reduced gluconeogenesis. The latter presents as hypoglycaemia in NaTGtreated rats, which is aggravated by fasting (Grosdidier, 2011; Report No. 37043 TSR). This mode of action (MoA) is thought to mediate the acute oral toxicity in fasted rats observed with all category members (see Table 2).
It can be predicted with high confidence that the target substances will display the same MoA and lead to the same effects seen with NaTG. - Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 4-h experiment (+/-S9): > 1600 µg/ml / 24-h experiment (-S9): >= 800 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- By analogy to ATG, NaTG is considered negative for gene mutations in mammalian cells.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- The read-across is a category approach based on the hypothesis that compounds in this category are transformed to a common compound. This approach serves to use existing data on genotoxicity, repeated-dose toxicity, and reproductive toxicity endpoints for substances in this category.
There are no relevant variations in properties among source substances and the same potency is predicted for all target substances. This is Scenario 5 of the RAAF11 . Substances ATG, MEATG, KTG, CaTG, and NaTG are different inorganic salts of a common acid, thioglycolic acid (TGA; synonym: 2- mercaptoacetic acid). They dissociate rapidly in aqueous media, e.g., the test organism, to the common thioglycolate anion and to their different counter ions (Figure 1). The water solubility of all category members is high, except for CaTG which is only moderately soluble in water.
In the repeated-dose toxicity studies with NaTG, specific toxicity is exerted via the well-investigated inhibition of mitochondrial fatty acid beta-oxidation by the thioglycolate (2-mercaptoacetate) anion 2,3,4. Inhibition of beta-oxidation leads to increased triglycerides and decreased acetyl-CoA in liver, and subsequently reduced gluconeogenesis. The latter presents as hypoglycaemia in NaTGtreated rats, which is aggravated by fasting (Grosdidier, 2011; Report No. 37043 TSR). This mode of action (MoA) is thought to mediate the acute oral toxicity in fasted rats observed with all category members (see Table 2).
It can be predicted with high confidence that the target substances will display the same MoA and lead to the same effects seen with NaTG. - Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: With S9 : 1000 µg/ml. Without S9 : 300 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: Human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- By analogy to TGA, NaTG is considered negative for chromosomal aberrations in vitro.
Referenceopen allclose all
Chemical Name: |
Sodium thioglycolate |
CAS Number: |
367-51-1 |
Study Type: |
Salmonella |
Study ID: |
471613 |
Study Result: |
Negative |
Year Completed: |
1979 |
Vehicle Control: |
Water |
Protocol: |
Preincubation |
Individual strain data is presented as mean ± standard error. |
Abbreviations are noted at bottom of page. |
Trial summary calls are shown in parentheses. |
Strain: TA1535 |
|||||||||||
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
||||||
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
|||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
|
0 |
7 |
0.7 |
7 |
0.6 |
6 |
0.9 |
7 |
2.6 |
7 |
0.7 |
|
10 |
6 |
1 |
6 |
0.9 |
5 |
0.9 |
6 |
2 |
8 |
1.2 |
|
33 |
5 |
1.5 |
6 |
0.9 |
7 |
1.5 |
9 |
1.2 |
6 |
1.3 |
|
100 |
8 |
3.5 |
9 |
1.3 |
7 |
0.6 |
9 |
0.7 |
6 |
0.9 |
|
333 |
6 |
0.6 |
6 |
0.9 |
5 |
1.2 |
7 |
1.5 |
8 |
1.2 |
|
1000 |
5 |
1.2 |
8 |
2 |
5 |
0.3 |
8 |
1.2 |
8 |
0.9 |
|
Positive Control |
288 |
32.3 |
251 |
40.8 |
106 |
16 |
43 |
4.1 |
135 |
9.7 |
Strain: TA100 |
|||||||||||||
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
|||||||
(Negative) |
(Negative) |
(Negative) |
(Equivocal) |
(Negative) |
(Negative) |
||||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
|
0 |
100 |
5 |
110 |
5.8 |
185 |
26.5 |
179 |
11.7 |
175 |
27.8 |
189 |
8.7 |
|
10 |
95 |
5 |
126 |
11.4 |
160 |
18 |
164 |
6.2 |
140 |
30.4 |
204 |
37.7 |
|
33 |
105 |
31.2 |
129 |
7.5 |
195 |
30 |
174 |
7.6 |
170 |
40.9 |
189 |
3.5 |
|
100 |
115 |
10 |
121 |
3.8 |
220 |
18 |
221 |
4.2 |
145 |
18 |
175 |
9 |
|
333 |
125 |
13.2 |
122 |
8.5 |
160 |
5 |
173 |
10.1 |
135 |
8.7 |
221 |
8.1 |
|
1000 |
120 |
30 |
124 |
8.8 |
215 |
13.2 |
202 |
4.3 |
155 |
35 |
181 |
18.1 |
|
Positive Control |
430 |
27.8 |
599 |
36.4 |
558 |
5.9 |
836 |
172.5 |
300 |
11.1 |
430 |
70.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The weight of evidence suggests that NaTG is not genotoxic.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- other: Micronucleus assay on mouse bone marrow
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Animals .
. Source: Harlan Winkelmann GmbH D-33178 Borchen
. Number of Animals: 72 (36 males/36 females), 6 males and 6 females per group
. Initial Age at Start of Acclimatisation: 8-10 weeks
. Acclimatisation: minimum 5 days
. Initial Body Weight at Start of Treatment: males mean value 37.1 g (SD ± 2.9 g) females mean value 31.5 g (SD ± 1.9 g)
- Environmental conditions
. Housing: single Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
. Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
. Temperature 22 ± 3 °C
. Relative humidity 30 - 70 %
. Artificial light 6.00 a.m. - 6.00 p.m.
- Food and water
. Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
. Water: tap water, ad libitum, (Gemeindewerke, D-64380 Roßdorf) - Route of administration:
- oral: gavage
- Vehicle:
- Name: deionised water
Route and Frequency of Administration: orally, once
Volume Administered: 10 mL/kg b.w. - Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- single
- Post exposure period:
- 24 and 48 hours
- Remarks:
- Doses / Concentrations:
0, 62.5, 125 and 250 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Name: CPA; Cyclophosphamide
Dissolved in: deionised water
Dosing: 40 mg/kg b.w.
Route and frequency of administration: orally, once
Volume administered: 10 mL/kg b.w. - Tissues and cell types examined:
- Bonne marrow
- Details of tissue and slide preparation:
- - Preparation of the bone marrow smears
Ten animals (5 males, 5 females) per test group (all groups after 24 hours and only the high dose group after 48 hours) were killed by CO2 inhalation, following by bleeding. The femurs of the animals were removed and the bone marrow was flushed out using foetal calf serum. After centrifugation, the supernatant was removed and the cells in the sediment were resuspended by shaking. A drop of this cell suspension was placed and spread on a slide. The slides were air dried and stained with May-Grünwald. The slides were coded so that the scorer is unaware of the treatment group of the slide under evaluation ("blind" scoring).
- Microscopic examination of the slides
For each animal, the number of the micronucleated polychromatic erythrocytes (MPE) was counted in 2000 polychromatic erythrocytes; the polychromatic (PE) and normochromatic (NE) erythrocyte ratio was established by scoring a total of 1000 erythrocytes (PE + NE). - Evaluation criteria:
- The study was considered valid as the following criteria are met:
- the negative controls are in the range of our historical control data.
- the positive controls are in the range of our historical control data.
- at least 4 animals per group and sex can be evaluated
- PCE to erythrocyte ratio should not be less than 20 % of the negative control.
A test item is classified as mutagenic if it induces either a dose-related increase or a clear increase in the number of micronucleated polychromatic erythrocytes in a single dose group. - Statistics:
- Statistical methods (nonparametric Mann-Whitney test (8)) will be used as an aid in evaluating the results. However, the primary point of consideration is the biological relevance of the results. A test item that fails to produce a biological relevant increase in the number of micronucleated polychromatic erythrocytes is considered non-mutagenic in this system.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- clinical signs
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- As estimated by a pre-experiment 250 mg Sodium Thioglycolate 98%, Pure per kg b.w. was suitable.
The mean number of polychromatic erythrocytes was not decreased after treatment with the test item as compared to the mean value of PCEs of the vehicle control indicating that Sodium Thioglycolate 98%, Pure had no cytotoxic properties in the bone marrow. In comparison to the corresponding vehicle controls there was no statistically significant or biologically relevant enhancement in the frequency of the detected micronuclei at any preparation interval and dose level after administration of the test item.
The mean values of micronuclei observed after treatment with Sodium Thioglycolate 98%, Pure were below or near to the value of the vehicle control group.
40 mg/kg b.w. cyclophosphamide administered orally was used as positive control which showed a statistically significant increase of induced micronucleus frequency. - Conclusions:
- Interpretation of results (migrated information): negative
Sodium Thioglycolate 98%, Pure is considered to be non-mutagenic in this micronucleus assay. - Executive summary:
The clastogenic potential of sodium thioglycolate was evaluated in a micronucleus assay on mouse bone marrow performed according to the OECD guideline # 474.Sodium thioglycolate was administered by single gavage to three groups of five male and five female NMRI mice at dose-levels of 0, 62.5, 125 and 250 mg/kg bw. The positive control was the cyclophosphamide administered orally. The polychromatic erythrocytes/normochromatic erythrocytesratios (PE/NE) in the treated groups were equivalent to those of the control groups. However, systemic exposure was confirmed by the clinical signs observed in males and females receiving 250 mg/kg bw of sodium thioglycolate. No increase of the frequency of the micronucleated polychromatic erythrocytes was observed in the bone marrow harvested 24 or 48 hours after the treatment. Positive and vehicle controls gave the expected results.
Reference
Summary of Micronucleus Test Results
test group |
dose (mg/kg b.w) |
sampling time (h) |
PCEs with micronuclei (%) |
range |
PCE per 2000 erythocytes |
vehicle |
0 |
24 |
0.050 |
0 - 2 |
1098 |
test item |
62.5 |
24 |
0.060 |
0 - 2 |
1124 |
test item |
125 |
24 |
0.025 |
0 - 1 |
1123 |
test item |
250 |
24 |
0.055 |
0 - 3 |
1100 |
Positive control |
40 |
24 |
1.500 |
10 -43 |
1099 |
test item |
250 |
48 |
0.095 |
0 - 6 |
1123 |
Historical Controls (1999 – 2004)
Vehicle Controls |
Positive Controls (CPA) |
|||||
Males |
Females |
Total |
Males |
Females |
Total |
|
Mean*±SD |
0.078±0.04 |
0.058±0.033 |
0.069±0.028 |
1.867±0.57 |
1.368±0.497 |
1.632±0.468 |
Range** |
0.01 - 0.23 |
0.0 - 0.19 |
0.01 - 0.15 |
0.70 -3.46 |
0.49 -3.55 |
0.77 - 3.48 |
No. of Experiments |
229 |
217 |
230 |
228 |
217 |
229 |
*: mean value (percent micronucleated cells)
**: range of the mean group values (percent micronucleated cells)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic
toxicity in vivo:
Several in vitro and in vivo genotoxicity studies were performed with thioglycolic acid and its salts. The conducted genotoxicity studies on thioglycolic acid or its salts described in this chapter can be bridged to each other, because in aquous solutions only the organic thioglycolate anion may have the potential to cause genotoxic effects in vitro or in vivo. All genotoxicity studies conducted to date have either negative results or are of doubtful significance. Therefore, the weight of evidence suggests that thioglycolic acid and its salts are non-genotoxic.
Justification for classification or non-classification
Conclusive, but not sufficient for classification.
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