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EC number: 250-264-8 | CAS number: 30618-84-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977-05-04 to 1979-03-07
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- only one dose of 2mL/kg; 30 minutes exposure; reporting deficits
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Mercaptoacetic acid, monoester with propane-1,2,3-triol
- EC Number:
- 250-264-8
- EC Name:
- Mercaptoacetic acid, monoester with propane-1,2,3-triol
- Cas Number:
- 30618-84-9
- Molecular formula:
- C5H10O4S
- IUPAC Name:
- 2,3-dihydroxypropyl 2-sulfanylacetate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Mixture of 22.3 parts of Glyceryl Mono Thioglycolate and 77.7 parts of Base Lotion #709-89-lC
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pel·Freez, Inc., USDA No. 7T-B-16, Rogers, Arkansas 72756
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.38 - 2.84 kg
- Housing: Each animal was housed individually in a suspended, galvanized steel wire cage with dimensions of 14" x 16" x Z4"
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 12 days
- Fasting period before study: 24 h
ENVIRONMENTAL CONDITIONS: No data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- In preparation of the test, the sides of the back of each rabbit were clipped using electric clippers. A 3-square-inch patch of hair was left above the dorsal midline. The clipped area of each animal constituted approximately 10 percent of the total body surface area. The animals were then returned to their cages and 24 hours allowed to elapse, before the first mixture application was made. The waiting period permitted the skin to recover from the slight disturbance of the stratum corneum caused by the clipping procedure and also permit the healing of any microscopic abrasions possibly produced during the process. The clipping procedure was repeated at least once a week, but more often if necessary. To prevent oral ingestion of the test material, each animal was fitted with a lightweight, flexible plastic collar which was worn throughout the investigational period.
A mixture of 22.3 parts of - Glyceryl Mono Thioglycolate and 77.7 parts of Part Il Base Lotion #709-B9-1C was evaluated. The test material was applied to the unoccluded partially clipped, 3-square-inch test skin sites at a dose level of 2.0 mL/kg.
REMOVAL OF TEST SUBSTANCE
- Washing: Warm tap water
- Time after start of exposure: 30 minutes - Details on analytical verification of doses or concentrations:
- Dose calculations were made weekly to adjust for changes in body weight.
- Duration of treatment / exposure:
- During the exposure period, the rabbits were placed in restrainers and subjected to a warm air flow from hair dryers installed above the rabbits. After
a 30 minute exposure period, the test sites were thoroughly rinsed with warm aerated tap water and then dried with towels and hair dryer. - Frequency of treatment:
- These dosing procedures were followed 5 days per week for 4 weeks for a total of 20 applications.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.0 mL/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Positive control:
- not examined
Examinations
- Observations and examinations performed and frequency:
- Mortality: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: days -12, -7, 14, 21, 28
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes / No / No data
- Time schedule for collection of blood: Prior to start of study and after 28 days
- Anaesthetic used for blood collection: No
- Animals fasted: Yes, 24 h
- How many animals: All
- Parameters checked: Total Leukocyte Count, Erythrocyte Count, Hemoglobin Concentration, Hematocrit Value, Differential Leukocyte Count (Pucent and Absolute), Cell Indices (MCV. MCH and MCHC)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Prior to start of study and after 28 days
- Anaesthetic used for blood collection: No
- Animals fasted: Yes, 24 h
- How many animals: All
- Parameters checked: Fasting Blood Glucose Concentration, Blood Urea Nitrogen Concentration (BUN), Serum Alkaline Phosphatase Activity (SAP), Serum Glutamic Pyruvic Transaminase Activity (SGPT), Serum Glutamic Oxalacetic Transaminase Activity (SGOT)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- At the conclusion of the investigational period, all rabbits were sacrificed. This was followed by a gross pathologic examination.
- Other examinations:
- The weights of the brain, liver, kidneys, spleen, heart, gonads, thyroid glands and adrenal glands were recorded.
- Statistics:
- Kruskal Wallis test and multiple comparison tests
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Mortality: One rabbit died. Rabbit 5-M from the untreated control group died during the 7th test day. The animal exhibited diarrhoea on test days 3, 4 and 5 and died two days later over the weekend. The immediate cause of death was not evident from the pathologic studies but was attributed to naturally occurring disease.
Reactions: No treament related pharmacotoxic symptoms were noted. The test animals exhibited severe hair loss upon repeated dermal exposure to the test material.
Effects on Body Weights: No adverse body weight effects were observed.
Hematology Studies and Clinical Blood Chemistry: No treatment related hematologic effects were noted.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 other: mL/kg bw/day
- Based on:
- test mat.
- Remarks:
- 22.3% GMT
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Summary of Local Skin Reactions
Group |
Local skin reactions after: |
|||
1 application |
3 applications |
5 applications |
7 applications |
|
untreated |
No skin reactions |
No skin reactions |
No skin reactions |
No skin reactions |
treated with test substance |
No skin reactions |
No skin reactions |
Noticeable hair loss 8/10 fissures 1/10 |
Noticeable hair loss 10/10 fissures 3/10 |
Table 2: Continued summary of Local Skin Reactions
Group |
Local skin reactions after: |
|||
10 applications |
12 applications |
15 applications |
20 applications |
|
untreated |
No skin reactions |
No skin reactions |
No skin reactions |
No skin reactions |
treated with test substance |
Noticeable hair
loss 10/10 fissures 1/10 |
Noticeable hair loss 6/10, severe hair loss 3/10, complete hair loss 1/10 |
Noticeable hair loss 4/10, severe hair loss 5/10, complete hair loss 1/10 |
Noticeable hair loss 2/10, severe hair loss 6/10, complete hair loss 2/10 |
Applicant's summary and conclusion
- Conclusions:
- At 2 mL/kg Glycerol Monothioglycolate 22.3 % showed no treatment related mortality, pharmacotoxic reactions, effects on body weight or hematologic effects. Because no dose finding preleminary studies are available here, these findings can only be used as supporting study.
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