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EC number: 226-540-9 | CAS number: 5421-46-5
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of the study was to investigate the influence of the pH (pH 6, 7, 8) on the percutaneous absorption of thioglycolic acid
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium mercaptoacetate
- EC Number:
- 226-540-9
- EC Name:
- Ammonium mercaptoacetate
- Cas Number:
- 5421-46-5
- Molecular formula:
- C2H4O2S.H3N
- IUPAC Name:
- ammonium 2-sulfanylacetate
- Details on test material:
- Thioglycolic acid titrated with ammonia to give solutions of pH 6, 7 and 8.
A solution of 14C-thioglycolic acid (Batch: 2675-291, radiochemical purity: 97.55 %) was gradually neutralized with a 25 % solution of ammonia resulting in three final solutions of 11 % ammonium 14C-thioglycolate with pH 6, pH 7 and pH 8, respectively (concentration calculated as thioglycolic acid).
Radioactive test substance:
Labelling: 14C
Preparation: synthesis by NEN, 549 Albany Street, Boston, USA
Supplier: NEN-DU PONT WIEN, A-1020, Lasallestr. 2/20, Austria
Radiochemical purity: 97.69 %
Storage: in the freezer at about -25 °C under nitrogen
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-labelled thioglycolate anion
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS:
Supplier: Forschnugsinstitut für Versuchstierzucht, A-2325 Himberg, Austria.
Weight: approx. 200 g
Age: male ca. 6-7weeks, females ca. 9-10 weeks
Housing: Single caging in metabolism cages (UNO B.V., Zevenaar, Holland)
Diet: ad libitum Altromin 1321ff
Water: ad libitum tap water
Acclimatization: 1 week
CONDITIONS:
Temperature: average 23°C
Relative humidity: average 75%
Air changes: 12/hour
Light-Dark cycle: 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Duration of exposure:
- 30 min
- Doses:
- 165 mg/kg bw
- No. of animals per group:
- 5
- Control animals:
- no
- Details on study design:
- Groups of 5 male and 5 female Sprague-Dawley rats were used to investigate the dermal bioavailability and excretion of ammonium thioglycolate.
Approx. 300 mg of the solutions (equivalent to 165 mg/kg bw) were applied to the clipped dorsal skin of the rats for 30 min and then washed off. The treatment was followed by a neutralization step where 0.3 ml of a "Natural styling solution" containing 2.1 % hydrogen peroxide was applied for 10 min and then washed off. The treated area was then covered with 4 layers of gauze fixed by adhesive tape and the animals were subsequently placed into metabolism cages for 72 hours.
The concentration of the test material (11 %), the time of exposure (30 min), the area of exposure (ratio application site to body surface: 0.026) and the neutralization step were chosen to mimic human exposure during the application of hair waiving products.
Solutions from the two rinsings were united. Urine and faeces were collected daily.
The animals were killed after 72 hours.
The application area plus some surrounding skin was excised and dissolved in Soluene-350 for analysis of radioactivity.
The radioactivity of the carcass was determined after removal of the remaining skin to avoid false 14C concentrations in the carcass due to skin, possibly contaminated e.g. by urine.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- yes
- Remarks:
- small focal redness appeared on the treated skin during application and remained at least until the area was covered
- Absorption in different matrices:
- Most of the 14C was removed from the rat skin during washing of the test material and neutralization solution (mean 96.1 - 96.8%). The mean 14C recovered in urine and faeces in the pH 6, pH 7, and pH 8 exposure groups was 0.139%, 0.119%, and 0.137%, respectively. The mean 14C-content of the skin at the application site for the pH 6, pH 7, and pH 8 exposure groups was 0.82%, 0.57%, and 0.60%, respectively. The mean cutaneous absorption for 11% Ammonium 14C-thioglycolate at pH 6, pH 7, and pH 8 was 1.09%, 0.81%, and 0.86%, respectively. Cutaneous absorption and 14C concentrations in urine, feces, and carcasses were higher in males than females, but it was determined that this was not statistically significant
- Total recovery:
- Total mean (sd) recovery was 97.9% (1.1), 97.5% (2.1) and 97.0% (1.5) at pH 6, 7 and 8, respectively.
Percutaneous absorption
- Key result
- Dose:
- 165 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 1 %
- Remarks on result:
- other: rinsing after 30 min
Any other information on results incl. tables
Recovery of the radioactivity after dermal administration of ammonium14C-thioglycolate to rats
Analysed sample |
14C-activity in % of applied dose, |
||
pH 6 |
pH 7 |
pH 8 |
|
Rinsings |
96.8 (1.2) |
96.7 (2.1) |
96.1 (1.4) |
Adsorption |
0.82 (0.43) |
0.57 (0.24) |
0.60 (0.34) |
Urine (0-72 h) |
0.11 (0.12) |
0.091 (0.073) |
0.11 (0.11) |
Faeces (0-72 h) |
0.029 (0.032) |
0.028 (0.025) |
0.027 (0.025) |
Carcass |
0.126 (0.087) |
0.116 (0.076) |
0.121 (0.089) |
Total recovery* |
97.9 (1.1) |
97.5 (2.1) |
97.0 (1.5) |
Cutaneous absorption |
1.09 |
0.81 |
0.86 |
*Total of urine, faeces, adsorption at the application site and carcass14C recovery.
Applicant's summary and conclusion
- Conclusions:
- The mean cutaneous absorption for 11% ammonium thioglycolate at pH 6, pH 7, and pH 8 was 1.09%, 0.81%, and 0.86%, respectively.
- Executive summary:
Three groups of rats (5/sex; ~200 g) received on the clipped dorsal skin approximately 300 mg of ammonium14C-thioglycolate (radiochemical purity 97.6%) as an 11% solution (equivalent to 165 mg a.i./kg bw or 133 mg/kg bw as thioglycolic acid) at pH 6, pH 7, and pH 8 for 30 minutes followed by a washing of the site. The test site was then neutralized with 0.3 ml of a “natural styling solution” containing 2.1% hydrogen peroxide for 10 minutes followed by a washing of the site. These applications were to mimic human exposure to hair waving products. After the second wash, the test sites were covered with four layers of gauze and the rats were placed into metabolism cages for 72 hours. Following the observation period, the animals were sacrificed. The test sites and surrounding skin were excised and dissolved in Soluene-350 for radioactivity analysis. The radioactivity of the waste wash water, urine, and feces as well as the carcasses was also measured.
Most of the14C was removed from the rat skin during washing of the test material and neutralization solution (mean 96.1 - 96.8%). The mean14C recovered in urine and faeces in the pH 6, pH 7, and pH 8 exposure groups was 0.139%, 0.119%, and 0.137%, respectively. The mean14C-content of the skin at the application site for the pH 6, pH 7, and pH 8 exposure groups was 0.82%, 0.57%, and 0.60%, respectively. The mean cutaneous absorption for 11% Ammonium14C-thioglycolate at pH 6, pH 7, and pH 8 was 1.09%, 0.81%, and 0.86%, respectively. Cutaneous absorption and14C concentrations in urine, feces, and carcasses were higher in males than females, but it was determined that this was not statistically significant.
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