Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-874-3 | CAS number: 111-48-8
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- OECD Guideline 407 adopted 1981; also according to Guideline of the EEC Commission 84/449 of April 1984.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Thiodiglycol
- EC Number:
- 203-874-3
- EC Name:
- Thiodiglycol
- Cas Number:
- 111-48-8
- Molecular formula:
- C4H10O2S
- IUPAC Name:
- 2-[(2-hydroxyethyl)sulfanyl]ethan-1-ol
- Details on test material:
- - Purity >= 98.4%
- Storage condition of test material: room temperature
- test substance, stability of the test substance, and solution of the test substance (stability, homogeneity) were analysed
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - 38 days old Wistar rats received from Karl Thomae, Biberach, Germany
- acclimatization period 4 days
HOUSING AND DIET
- rats singly housed
- temperature 20-24°C, relative humidity 30-70%, day/night rythm 12h/12h
- room desinfected before use
- food (Kliba 343 feed) and water ad libitum
ANALYSIS
- food and drinking water analysed, no contamination
TEST ORGANISMS at initiation of experiment
- Age: 42 days
- Weight at study initiation: males 164-169 g, females 138-155 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: bidistilled water
- Details on oral exposure:
- - Vehicle:
bidistilled water
- Concentration in vehicle:
0 or 100 mg/ml
- Volume applied:
all animals received 10 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - test substance, stability of the test substance, and solution of the test substance (stability, homogeneity) were analysed by GC methods
- analytical check confirmed the correct concentration and stability/homogeneity - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 or 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 3 days
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CLINICAL EXAMINATIONS:
- Clinical signs and mortality checked twice daily
- Body weight determined on day 0 and then in weekly intervals
- Food consumption determined weekly (over a period of 7 d)
- Samples for hematology and clinical chemistry: Blood sampling on day 31 (sampling in a randomized sequence) from retroorbital venous plexus
- Hematological parameters: leukocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, differential blood count, blood clotting analysis
- Clinical chemistry parameters: Enzymes: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum-gamma-glutamyltransferase; blood chemistry: Na, K, Cl, Ca, Mg, inorganic phosphate, urea, creatinine, glucose, total bilirubin, total protein, albumin, globulins, triglycerides, cholesterol; hormones: total triiodothyronine (T3), total thyroxine (T4) - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- according to OECD guideline 407 (1981) - Other examinations:
- no
- Statistics:
- - for clinical examinations, hematology and clinical chemistry analysis done via the MANN-WHITNEY-U-Test, marked level of significance p < 0.05
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- TOXIC RESPONSE/EFFECTS
- No significant effects were observed (exceptions see below) at any parameter listed in Materials and Methods.
- Exceptions: a) in males significant decrease in red blood cell counts, hemoglobin level and hematocrit; effect within the range of variation, values in control males unusually high; effect considered to be incidental b) in males significant decrease in bilirubin and albumin concentrations; effect within the range of variation (laboratory historical control), clinical and histopathological examinations revealed no findings in accordance with these changes; effects considered to be of no toxicological significance
- Pathology: no changes related to the treatment
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: general toxicity
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a sub-acute oral study (limit test) no changes were observed related to the test substance administered. NOAEL = 1000 mg/kg bw/day.
- Executive summary:
GLP guideline study.
In a subacute study Wistar rats (n=5 per dose per sex) received once daily (5 days per week) for 28 days 0 or 1000 mg/kg bw (limit test). Rats were sacrificed 3 days after the end of the exposure period. No clinical signs were detected and no effects on body weight gain or food consumption. Hematology and clinical chemistry (blood sampling 3 days after termination of the exposure period) did not show any treatment related effects. No effects were detected at necropsy including organ weights. No treatment related effects at histopathological examinations.
Conclusion: In a sub-acute oral study (limit test) no changes were observed related to the test substance administered. NOAEL = 1000 mg/kg bw/day.
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.
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.