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EC number: 211-750-5 | CAS number: 693-36-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- June 2018
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dioctadecyl 3,3'-thiodipropionate
- EC Number:
- 211-750-5
- EC Name:
- Dioctadecyl 3,3'-thiodipropionate
- Cas Number:
- 693-36-7
- Molecular formula:
- C42H82O4S
- IUPAC Name:
- dioctadecyl 3,3'-thiodipropionate
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI(Han)
- Details on species / strain selection:
- Rats are a generally accepted species for the type of study and for the specific strain, extensive experience and historical control data is available at the laboratory.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: at least 5-6 weeks
- Housing: Up to 5 animals of the same sex and same dosing group together. Polycarbonate cages (Makrolon type IV, height 18 cm or Makrolon type 2000P, height 21.5 cm) containing sterilized wooden fibers as bedding material (Safe S 8 15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. During locomotor activity monitoring, animals are housed individually in a Hi-temp polycarbonate cage (Ancare corp., USA; dimensions: 48.3 x 26.7 x 20.3 cm) without cage-enrichment, bedding material, food and water.
- Diet (e.g. ad libitum): SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany ad libitum. During motor activity measurements, animals will not have access to food for a maximum of 2 hours.
- Water (e.g. ad libitum): Municipal tap water ad libitum
- Acclimation period: ca. 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 17.08.2022 - 30.11.2022
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Gavage is a preferred administration method for the study conducted and was found to be well tolerated in preliminary studies.
- Vehicle:
- methylcellulose
- Remarks:
- 1% Methylcellulose
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The dosing formulations will be prepared at least weekly, filled out in daily portions and stored in the refrigerator protected from light. Dosing formulations will be removed from the refrigerator at least 30 minutes before dosing and will be stirred at room temperature.
No adjustment will be made for specific gravity of the test item and vehicle. No correction will be made for the purity/composition of the test item or vehicle.
VEHICLE
- Justification for use and choice of vehicle (if other than water): the test item is not soluble in water, 1% MC resulted in homogenous and stable dispersions which were well tolerated by the animals in a preliminary study.
- Concentration in vehicle: 0, 10, 30, 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration and homogeneity analysis.
Stability analyses performed previously in conjunction with the method development and validation demonstrated that the test material is stable in the vehicle when prepared and stored under the same conditions at concentrations bracketing those used in the present study. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected based on the results of a previous dose-range finding study. The highest dose selected represents the limit dose for the study design. Dose spacing was conducted with a factor of ca. 3 in accordance with the OECD guideline.
- Fasting period before blood sampling for clinical biochemistry: yes (overnight)
- Dose range finding studies: a 14-day dose range findings study was previously conducted.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Mortality check at least twice daily beginning upon arrival through termination/release. Cageside observations at least once daily; from Day 1 at 0 to 1 hours postdose.
Except on days of receipt and necropsy where frequency will be at least once daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once before the first administration of the test material and weekly during the Treatment Period.
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly; from at least Day 1 and throughout the study.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Water consumption is monitored on a regular basis by visual inspection of the water bottles.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Pre-treatment period (all main study animals); week 13 (control and high dose group, if treatment-related findings are noted, the other animals will also be examined.)
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of treatment
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all animals
- Parameters examined: White Blood Cell (WBC), Neutrophils (absolute), Lymphocytes (absolute), Monocytes (absolute), Eosinophils (absolute), Basophils (absolute), Large unstained cells (LUC) (absolute), Red Blood Cell (RBC), Reticulocytes (absolute), Red Blood Cell Distribution Width (RDW), Hemoglobin, Hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelets; Coagulation: Prothrombin time (PT), Activated partial thromboplastin time (APTT)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of treatment
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all animals
- Parameters examined: see table below.
PLASMA/SERUM HORMONES/LIPIDS: Yes
Time schedule for collection of blood: end of treatment
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all animals
- Parameters examined: see table below (clinical chemistry)
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Once during the Dosing Period. The first 5 animals per sex per group during Week 13.
- Battery of functions tested: see table below. Locomotor activity (1h recording period under normal laboratory light conditions, using a computerized monitoring system). - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; complete necropsy examination, which will include evaluation of the carcass and musculoskeletal system; all external surfaces and orifices; cranial cavity and external surfaces of the brain; and thoracic, abdominal, and pelvic cavities with their associated organs and tissues.
Organ weights: see table below
HISTOPATHOLOGY: Yes (see table)
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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