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EC number: 229-765-0 | CAS number: 6713-03-7
- 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
Description of key information
The short-term repeated dose toxicity of 1-[(2-hydroxyethyl)thio]propan-2-ol via the oral route was investigated during a study performed using a method similar to OECD Test Guideline 407 (GLP) with deviations. The test substance was administered orally at doses of 20, 140 and 1000 mg/kg bw/day to Sprague-Dawley rats. Pure water was used as a vehicle and this was also used in the control group. Recovery animals were included for the control and highest dose, and observed for 14 days after the end of the treatment. Animals were observed daily for clinical signs. Body weights were recorded on the first day of the treatment then weekly. Haematology and clinical chemistry were investigated, and urinalysis performed. At the end of the treatment or of the recovery period, animals were sacrificed, and a gross pathology and histopathology performed. All the rats survived to the end of the studies. No clinical signs or effects on body weight were observed in any of the rats. Changes were detected in the haematology and clinical chemistry parameters, and during the urinalysis, organ weighting, and histopathology, but they were not considered as significant and treatment-related. It is concluded that no significant signs of toxicity were observed. The NOAEL was determined to be 1,000 mg/kg bw/day as it was the highest dose evaluated.
In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 13 July 1994 to 14 November 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Japanese Guidelines on Industrial Chemicals (1986)
- Deviations:
- yes
- Remarks:
- No FOB was performed, some recommended organs were not weighted and/or examined.
- GLP compliance:
- yes
- Remarks:
- Compliant with Japanese GLP Standards
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks old
- Weight at study initiation: Males: 142 - 175 g and Females: 116 - 144 g
Housing: Two rats of the same sex were housed in a single polycarbonate cage (256 mm W x 426 mm D x 200 mmH) from Tokiwa Kagaku Kikai Co., Ltd
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days
DETAILS OF FOOD AND WATER QUALITY:
A pellet diet (MF Oriental Yeast Co., Ltd) was provided and changes once a week. Ordinary tap water was filtered through a 5 - µm filter and disinfected by UV irradiation before being provided ad libitum to animals. Drinking water bottles were changed once a week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25- Humidity (%): 40 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Details on route of administration:
- The test substance was administered orally using a gastric tube
- Vehicle:
- water
- Remarks:
- pure water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dosing solution for the highest-dose group was prepared by dissolving the test substance in pure water. The dosing solutions for mid-dose and low-dose groups were prepared by diluting the higher-dose solution with pure water. The frequency of preparation was daily until 5-day stability was confirmed, once every 5 days until 10-day stability was confirmed, and once a week thereafter. The dosing solutions were stored in a refrigerator with tight containers.
DIET PREPARATION
- Rate of preparation of diet (frequency): once a week
- Storage temperature of food: Not specified
VEHICLE
- Concentration in vehicle: 1000 mg/kg, 140 mg/kg and 20 mg/kg
- Amount of vehicle (if gavage): dosing volume was 1.0 ml / 100 g bw (based on the most recent weight)
- Purity: pure water - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- The test substance was administered to each rat, every morning, once a day for 28 days.
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 140 mg/kg bw/day (nominal)
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6 animals / sex / dose
6 recovery animals / sex for the highest dose and the control - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: A preliminary 7-day study was carried out with doses of 500 and 1000 mg/kg bw with 3 male rats and 3 female rats per group. No abnormalities were observed.
- Rationale for animal assignment (if not random): Rats were grouped by the 'stratified-by-weight' randomised method - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All rats were observed daily for evidence of any systemic reactions to treatment or any other illnesses by assessing clinical signs and behaviour.
BODY WEIGHT: Yes
- Time schedule for examinations: All rats were weighed on the first day of treatment, and then once a week thereafter with an electronic balance
FOOD EFFICIENCY: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were obtained from the inferior vena cava of non-fasting rats under anesthesia at the scheduled sacrifice
- Anaesthetic used for blood collection: Yes (intraperitoneal thiopental sodium anesthesia - Ravonal, Tanabe Seiyaku Co., Ltd)
- Animals fasted: No
- How many animals: Not specified
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Same an haemotology tests occurred above
- Animals fasted: No
- How many animals: Not specified
URINALYSIS: Yes
- Time schedule for collection of urine: Fresh urine was collected from all rats at 26 days after the beginning of the treatment.
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Bartlett's test was used first, then groups were compared by analysis of variance when group variance was determined to be homogeneous. Dunnett's multiple range test or Scheffé's test was used when intergroup differences were significant. Comparisons were done by the Kruskal-Wallis test when Bartlett's test indicated heterogeneous group variance. When intergroup differences were significant, Dunnett's rank sum test or Scheffé's test was used. Urinalysis data was analysed by Armitage's x(2) test.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No changes were noted in any animals during the treatment or recovery periods
- Mortality:
- no mortality observed
- Description (incidence):
- No animals died during the treatment and recovery periods
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weight of all treated groups showed a similar increase to the body weight of the control group
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The control group and treated group had a similar food consumption
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No changes due to the test substance was detected in either the treated or recovery periods. At the end of the treatment period, the hematocrit increased in male rats of the 140 mg/kg group, this was not found in the 1000 mg/kg therefore was not ascribed to the test substance. At the end of recovery period the reticulocyte count was increased in females and the MCHC was increased in males, the percentage of lymphocytes in the WBC count was decreased in females. However these changes were not due to the test substance, because they were slight and not found at the end of the treatment period.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At the end of the treatment period, the glucose level was increased and the A/G ratio was decreased in female rats exposed to 140 mg/kg. These changes were not ascribed to the test substance because no changes were observed in the 1000 mg/kg group. At the end of the recovery period, glucose levels was increased in males, however this was not due to the test substance because it was not found at the end of the treatment period.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The level of ketones was increased in female rats exposed to 20 mg/kg. This change was not due to the test substance, because it was not found in the group exposed to 140 mg/kg or 1000 mg/kg exposed groups.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At the end of the treatment period, the absolute ovarian weight was decreased and the relative brain weight was increased in female test subjects exposed to 1000 mg/kg. These changes were slight and were considered to be within the normal range. At the end of the recovery period, the total adrenal weight in males was decreased and the absolute and relative testicular weights were increased. However, these changes were not associated with the test substance as no such changes were found at the end of the treatment period.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At the end of the treatment period, thickening of the right femur was found in one control male and hepatodiaphragmatic nodule was found in one control female. These changes were considered to be incidental and not related to the test substance.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Basophilic change of the renal tubular epithelium and cystic dilation of the renal tubules, focal necrosis, and focal myocardial degeneration were found in rats of the control and groups exposed to 1000 mg/kg. However, these lesions were considered to be incidental findings or spontaneous changes as they showed a similar incidence in the two groups. The thickened femur of the control male showed no histological abnormalities.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Hepatic microgranuloma were found in rats of the control and groups exposed to 1000 mg/kg. However, these lesions were considered to be incidental findings or spontaneous changes as they showed a similar incidence in the two groups.
- Other effects:
- not examined
- Details on results:
- Body weight, food consumption, hematology tests, clinical chemistry tests, urinalysis and pathological examinations revealed no evidence of toxicity.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- Critical effects observed:
- no
- Conclusions:
- The NOAEL for the test substance was found to be greater than 1,000 mg/kg bw/day in the test animals. No significant adverse effects were observed.
- Executive summary:
A 28 -day repeat dose toxicity study was performed on the registered substance using a method similar to OECD Test Guideline 407 (GLP) with deviations. The test substance was administered orally at doses of 20, 140 and 1000 mg/kg bw/day to Sprague-Dawley rats. Pure water was used as a vehicle and this was also used in the control group. Recovery animals were included for the control and highest dose, and observed for 14 days after the end of the treatment.
Animals were observed daily for clinical signs. Body weights were recorded on the first day of the treatment then weekly. Haematology and clinical chemistry were investigated, and urinalysis performed. At the end of the treatment or of the recovery period, animals were sacrificed, and a gross pathology and histopathology performed. All the rats survived to the end of the studies. No clinical signs or effects on body weight were observed in any of the rats. Changes were detected in the haematology and clinical chemistry parameters, and during the urinalysis, organ weighting, and histopathology, but they were not considered as significant and treatment-related.
It is concluded that no significant signs of toxicity were observed. The NOAEL was determined to be 1,000 mg/kg bw/day as it was the highest dose evaluated.
Reference
See attached report for all graphs and tables.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A GLP-compliant study was performed according to a method similar to the OECD Testing Guideline 407.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
A GLP-compliant short-term repeated-dose toxicity study was performed on rats via the oral route using a method similar to the OECD Testing Guideline 407. When tested up to 1,000 mg/kg bw/d for 28 days, 1-[(2-hydroxyethyl)thio]propan-2-ol did not induce any significant treatment-related effects.
In accordance with Annex VIII of REACH, Column 2, no repeated-dose toxicity testing of 1-[(2-hydroxyethyl)thio]propan-2-ol via the inhalation and dermal routes was performed as exposure to humans by these routes is unlikely.
Based on the available information on repeated-dose toxicity 1-[(2-hydroxyethyl)thio]propan-2-ol does not meet the criteria for classification according to Regulation (EC) N° 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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