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EC number: 204-815-4 | CAS number: 126-97-6
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Developmental Toxicity Evaluation of Sodium Thioglycolate Administered Topically to Sprague-Dawley (CD) Rats and New Zealand White Rabbits
- Author:
- Tyl RW, Price CJ, Marr MC, Myers BB, van Birgelen APJM and Jahnke GD
- Year:
- 2 003
- Bibliographic source:
- Birth Defects Research (Part B) 68:144-161
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium mercaptoacetate
- EC Number:
- 206-696-4
- EC Name:
- Sodium mercaptoacetate
- Cas Number:
- 367-51-1
- Molecular formula:
- C2H4O2S.Na
- IUPAC Name:
- sodium sulfanylacetate
- Details on test material:
- Test substance: Sodium thioglycolate
CAS No.: 367-51-1
Source: Sigma Chemical Company by Midwest Research Institute (Kansas City, MO)
Batch: No. 88H1166
Purity: 99% (identity confirmed by infrared spectrometry) Solvent: 95% ethanol:distilled water (1:1).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Test animals:
- Source: Charles River Laboratories (Raleigh, NC).
- Age: no data
- Weight at dosing: ca. 250 g
- Acclimation period: no data
- Diet: Purina Certified Rodent Chow (No. 5002), ad libitum
- Water: Tap water, ad libitum
- Housing: singly housed in solid-bottom polycarbonate cages with stainless steel wire lids with Sani-Chips certified hardwood bedding
Environmental conditions:
- Temperature: 70.0-72.81 F
- Humidity: 28.0-58 %
- Air changes: no data
- Photoperiod: Alternating 12-hour light and dark cycles
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: 95% ethanol:distilled water, 1:1
- Details on exposure:
- Treatment: 1.5 ml/kg of test material in vehicle or vehicle alone was applied directly to a 3x3 inch shaved area on the dorsum of the rat with a glass syringe fitted with a 16-gauge, stainless-steel, ball-tipped dosing needle. The formulation was allowed to remain on the animal for a minimum of 6 hr/treatment day. At the end of each 6-hr period, the application site was wiped with warmwater-soaked gauze to remove residual vehicle or sodium thioglycolate.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Prepared weekly based on stability information and were verified to be within 92.7-103.5 % of target.
- Duration of treatment / exposure:
- gestation days 6-19
- Frequency of treatment:
- daily
- Duration of test:
- necropsy on GD 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Pregnant Sprague Dawley derived (CD.) rats were topically exposed to sodium thioglycolate in vehicle (50, 100, and 200 mg/kg/day) or vehicle alone (95% ethanol:distilled water, 1:1) from gestational day (gd) 6 through 19.
Examinations
- Maternal examinations:
- Females were monitored at regular intervals throughout gestation for clinical signs (including dosing site condition), feed and water intake, and body weight. At necropsy on GD 20, the following were recorded: maternal clinical condition; body, liver and gravid uterine weights; and pregnancy status.
- Ovaries and uterine content:
- The number of ovarian corpora lutea and uterine implantations (resorbed, dead, or live fetuses) was recorded.
- Fetal examinations:
- All live foetuses were counted, weighed, and examined for external alterations, including cleft palate. Approximately 50% of the live foetuses per litter were sexed internally and examined for visceral alterations. These foetuses were decapitated and the heads fixed, decalcified, and examined for soft tissue craniofacial alterations. All foetal carcasses were eviscerated (and foetuses not scheduled for a visceral examination were sexed internally), macerated, and stained with alizarin red S and alcian blue. Intact foetuses (those not decapitated) were examined for ossified and cartilaginous skeletal alterations.
- Statistics:
- The unit for statistical measurement was the pregnant female or the litter. Quantitative continuous data (e.g., maternal body weights, foetal body weights, feed consumption, etc.) were compared among treatment groups, per species, by parametric statistical tests whenever Bartlett test for homogeneity of variance was not significant. General linear models (GLM) procedures were applied to the ANOVA and the tests for linear trend. Before GLM analysis, an arc sine-square root transformation was carried out on all litter-derived percentage data (e.g., % resorptions/litter, % malformations/litter, % variations/litter) (Snedecor and Cochran, 1967). For litter-derived percentage data, the ANOVA was weighted according to litter size. When a significant (p < 0.05) main effect for dose occurred, Dunnett's multiple comparison test (Dunnett, 1955, 1964) was used to compare each treatment group to the control group for that measure. A one-tailed (i.e., Dunnett's test) was used for all pairwise comparisons to the vehicle control group, except that a two-tailed test was used for maternal body and organ weight parameters, maternal feed consumption, fetal body weight, and percent males per litter.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- see below
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Details on results:
- Sodium thioglycolate treatment was associated with one maternal death at 200 mg/kg/day (only clinical observations at the dosing site preceded death). Other effects, dependent on dose and exposure duration, included body weight and weight gain reductions, changes in relative feed and water intake, and discolouration and slight erythema at the application site. Feed consumption in g/kg/day was significantly increased above the control at 50 (5.4%) and 100 (6.1%) mg/kg/day, but not at 200 mg/kg/day (2.2%). Maternal water consumption in g/kg/day was significantly increased at 200 mg/kg/day, (12.7%) and slightly (but not statistically significantly) increased at 50 (3.2%) and 100 (5.1%) mg/kg/day. Maternal body weights and body weight changes were decreased only at 200 mg/kg/day. At scheduled necropsy, there were no macroscopic indications of organ toxicity. In addition, organ weights and gravid uterine weights were equivalent across groups; maternal body weight was significantly reduced at 200 mg/kg/day.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- < 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- food consumption and compound intake
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- <= 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- food consumption and compound intake
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- effects observed, treatment-related
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Prenatal viability was unaffected by maternal exposure to sodium thioglycolate. The incidences of foetal external, visceral, and skeletal alterations were also unaffected. A significant, dose-related, upward trend was present for % foetuses with skeletal variations per litter, but there were no significant pairwise comparisons to the vehicle control group value. The historical data presented in the study report shown a range of 0.58 to 25.65 % for this parameter, with 9 out of 21 studies (43%) with a % higher than 15.1% (the highest value observed at 200 mg/kg bw/d). Accordingly, this effect was not considered as treatment-related. Body weights of male and female foetuses per litter at 200 mg/kg/day were significantly lower than control values.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- changes in litter size and weights
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- changes in litter size and weights
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Maternal Toxicity in CD Rats Exposed to Sodium Thioglycolate by Topical Application on Gestational Days 6 Through 19
Sodium thioglycolate (mg/kg/day, dermal) |
||||
0 |
50 |
100 |
200 |
|
Maternal pregnancy status |
||||
Treated, n |
25 |
25 |
25 |
25 |
Removed, n |
0 |
0 |
0 |
0 |
Dead or euthanized, n |
0 |
0 |
0 |
1a |
Pregnant at sacrifice, n(%) |
25(100) |
23(92) |
23(92) |
21(88)b |
Maternal body weight changes (g)c,d |
||||
Pretreatment wt. gain (GD 0–6) |
32.2±1.3h |
29.21±1 |
28.4±2.1 |
26.5±1.6 |
Gestation weight gain (GD 0–20) |
135.6±3.3i |
129.7±4.4 |
127.0±5.0 |
112.5±5.9k |
Treatment weight gain (GD 6–20) |
110.1±3.1i |
106.5±4.0 |
104.8±3.8 |
92.7±5.7j |
Corrected weight gaine |
49.6±1.8i |
45.6±2.4 |
43.9±3.3 |
34.8±2.8k |
Gravid uterine wt. |
86.0±3.2 |
84.1±3.1 |
83.0±3.1 |
77.6±4.9 |
Maternal organ weightsc,f |
||||
Liver Absolute (g) |
17.78±0.23 |
17.64±0.40 |
17.69v0.29 |
17.02±0.27 |
Relative (% sacrifice wt.)f |
4.53±0.04 |
4.56±0.07 |
4.62±0.05 |
4.65±0.08 |
Kidney Absolute (g) |
2.22±0.04 |
2.19±0.05 |
2.26±0.05 |
2.20±0.04 |
Relative (% sacrifice wt.)f |
0.57±0.01h |
0.57±0.01 |
0.59±0.01 |
0.60±70.01 |
Maternal feed consumptionc,g |
||||
Pretreatment period (gd 0–6) |
||||
Absolute (g/day) |
23.4±0.5 |
23.2±0.6 |
22.6±0.6 |
22.5±0.4 |
Relative (g/kg/day) |
85.0±1.4 |
84.6±1.7 |
83.3±2.0 |
83.6±1.3 |
Treatment period (GD 6–20) |
||||
Absolute (g/day) |
26.3±0.3 |
27.5±0.4 |
27.3±0.5 |
25.5±0.4 |
Relative (g/kg/day) |
77.1±0.5 |
81.3±0.9k |
81.8±0.8k |
78.8±0.8 |
Maternal water consumptionc,g |
||||
Pretreatment period (gd 0–6) |
||||
Absolute (g/day) |
35.7±1.2 |
34.2±0.9 |
32.4±1.1 |
34.1±0.9 |
Relative (g/kg/day) |
129.8v4.3 |
125.2v2.9 |
119.0±3.5 |
126.9±3.1 |
Treatment period (gd 6–20) |
||||
Absolute (g/day) |
43.6±1.3 |
44.1±1.3 |
44.4±1.1 |
46.2±1.2 |
Relative (g/kg/day) |
127.1±3.2i |
131.2±3.3 |
133.6±2.6 |
143.3v3.9k |
aDam 4 was found dead on the morning of gd 18.
bDam 31 had only one implantation site, and no live fetuses on gd 20.
cIncludes all dams pregnant at sacrifice; mean 7 SEM; gd, gestational day.
dBody weights were recorded in the morning of each designated gestational day.
eWeight change during gestation minus gravid uterine weight.
fCalculated using body weight at the time of sacrifice on gd 20.
gRelative feed and water consumption (g/kg/day) were calculated using appropriate body weights.
hp<0.05; Test for linear trend.
ip<0.01; Test for linear trend.
jp<0.05; Dunnett’s test
k p<0.01; Dunnett’s test.
Developmental Toxicity in CDsRat Fetuses Following Maternal Exposure to Sodium Thioglycolate by Topical. Application on Gestational Days 6 Through 19
Sodium Thioglycolate (mg/kg/day, dermal) |
||||
0 |
50 |
100 |
200 |
|
All littersa,b |
25 |
23 |
23 |
21 |
No. corpora lutea/dam |
17.5±0.4 |
16.7±0.5 |
16.4±0.5 |
16.8±0.7 |
No. implantation sites/litter |
15.6±0.5 |
15.1±0.6 |
14.7±0.7 |
15.4±v0.8 |
% preimplantation loss/litter |
11.2±2.7 |
10.3±2.4 |
11.6±3.6 |
10.5±4.1 |
% resorptions/litter |
3.9±1.3 |
4.6±1.4 |
3.0±0.9 |
11.2±5.1 |
% litters with resorptions |
40 |
48 |
35 |
52 |
% late fetal deaths/litter |
0.0±0.0 |
0.3±0.3 |
0.0±0.0 |
0.0±0.0 |
% litters with late fetal deaths |
0 |
4 |
0 |
0 |
Live littersb,c |
25 |
23 |
23 |
20d |
No. live fetuses/litter |
15.0±0.6 |
14.4±0.6 |
14.2±0.6 |
15.1±0.6 |
Avg. male fetal body wt./litter (g) |
3.73±0.06f |
3.70±0.05 |
3.75±0.08 |
3.42±0.08g |
Avg. female fetal body wt./litter (g) |
3.50±0.05e |
3.56±0.05 |
3.61±0.10 |
3.2570.08g |
% male fetuses/litter |
45.173.6 |
52.373.5 |
50.673.2 |
52.5±2.3 |
% externally malformed fetuses/litter |
0.0±0.0 |
0.0±0.0 |
0.9±0.7 |
0.3±0.3 |
% viscerally malformed fetuses/litter |
0.0±0.0 |
0.5±0.5 |
0.0±0.0 |
2.2±1.7 |
% skeletally malformed fetuses/litter |
2.3±1.8 |
2.2±1.0 |
1.2±0.8 |
4.5±2.6 |
% malformed fetuses/litter |
1.1±0.9 |
1.4±0.6 |
1.5±0.7 |
3.4±2.2 |
% fetuses with external variations/litter |
0.5±0.5 |
0.5±0.4 |
0.0±0.0 |
0.3±0.3 |
% fetuses with visceral variations/litter |
3.3±1.3 |
5.0±1.5 |
3.7±1.7 |
3.7±2.2 |
% fetuses with skeletal variations/litter |
3.9±1.3f |
6.4±2.3 |
11.2±3.0 |
15.1±4.2 |
% fetuses with variations/litter |
4.1±1.0 |
6.3±1.4 |
7.3±1.7 |
9.9±2.6 |
aIncludes all dams pregnant at sacrifice; litter size¼no. implantation sites per dam.
bReported as the mean 7 SEM.
cIncludes only dams with live fetuses; litter size¼no. live fetuses per dam.
dOne female at 200 mg/kg/day had a fully resorbed litter at scheduled necropsy.
ep<0.05; Test for linear trend.
fp<0.01; Test for linear trend.
gp<0.05; Dunnett’s test.
Applicant's summary and conclusion
- Conclusions:
- Topically applied sodium thioglycolate resulted in toxicity to the dam at 200 mg/kg/day (expressed as reduced body weights and weight gain, increased relative water consumption, observations at the dosing site and one death). Treatment-related increases in feed consumption (and observations at the application site) were also present at 50 and 100 mg/kg/day, in the absence of increased body weights or body weight change. This is an uncommon finding and has been previously observed in rats exposed to sodium thioglycolate, attributed to a block in fatty acid metabolism. Sodium thioglycolate at 200 mg/kg/day also resulted in significantly decreased male and female foetal body weights per litter, with no other evidence of embryofoetal toxicity and no evidence of treatment-related teratogenicity. Based on the study findings, a no observed adverse effect level (NOAEL) could not be identified for maternal toxicity while for developmental toxicity, 100 mg/kg/day was the NOAEL.
- Executive summary:
The developmental toxicity of sodium thioglycolate was evaluated in pregnant rats in a study performed according to a method comparable to the OECD guideline # 414. Pregnant Sprague-Dawley rats were exposed topically, 6 hr/day, to sodium thioglycolate (99% pure) in vehicle (95% ethanol:distilled water, 1:1) from gestational day (gd) 6 through 19 at dose levels of 0, 50, 100, and 200 mg/kg bw/d. Twenty-five timed-mated female rats were assigned to each group and monitored at regular intervals throughout gestation for clinical signs (including dosing site condition), feed and water intake, and body weight. At necropsy on gestational day 20; the following were recorded: maternal clinical condition; body, liver and gravid uterine weights; and pregnancy status. The number of ovarian corpora lutea and uterine implantations (resorbed, dead, or live foetuses) was recorded. All live foetuses were counted, weighed, and examined for external alterations, including cleft palate. Approximately 50% of the live rat foetuses per litter were sexed internally and examined for visceral alterations. These foetuses were decapitated and the heads fixed, decalcified, and examined for soft tissue craniofacial alterations. All foetal carcasses were eviscerated (and rat foetuses not scheduled for a visceral examination were sexed internally), macerated, and stained with alizarin red S and alcian blue. Intact rat foetuses (those not decapitated) were examined for ossified and cartilaginous skeletal alterations.
Sodium thioglycolate treatment was associated with one maternal death at 200 mg/kg/d (only clinical observations at the dosing site preceded death). Other effects, dependent on dose and exposure duration, included body weight and weight gain reductions, changes in relative feed and water intake, and discoloration and slight erythema at the application site. Feed consumption was significantly increased above the control at 50 (5.4%) and 100 (6.1%) mg/kg bw/d, but not at 200 mg/kg bw/d (2.2%). Maternal water consumption was significantly increased at 200 mg/kg bw/d (12.7%) and slightly (but not statistically significantly) increased at 50 (3.2%) and 100 (5.1%) mg/kg bw/d. Maternal body weights and body weight changes were decreased only at 200 mg/kg bw/d. At scheduled necropsy, there were no macroscopic indications of organ toxicity. In addition, organ weights and gravid uterine weights were equivalent across groups; maternal body weight was significantly reduced at 200 mg/kg/d. Prenatal viability was unaffected by maternal exposure to sodium thioglycolate. The incidences of foetal external, visceral, and skeletal alterations were also unaffected. A significant, dose-related, upward trend was present for % foetuses with skeletal variations per litter, but there were no significant pairwise comparisons to the vehicle control group value and the % were in the range of the historical control data . Body weights of male and female foetuses per litter at 200 mg/kg bw/d were significantly lower than control values. The maternal NOAEL could not be identified.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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