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EC number: 443-930-6 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-03-07 to 2006-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 443-930-6
- EC Name:
- -
- Cas Number:
- 866594-60-7
- Molecular formula:
- C7H10O4
- IUPAC Name:
- (3AS,4S,6AR)-4-METHOXYTETRAHYDROFURO[3,4- B]FURAN-2(3H)-ONE
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TIC2782 (T002907)
- Substance type: white solid
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: 00467090 (= Charge 05C0836)
- Expiration date of the lot/batch: 2006-05-04
- Stability of test item: stable under storage conditions
- Stability under test conditions: Unknown in PEG 300
- Storage condition of test material: At room temperature (range of 17-23°C),away from direct sunlight.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HanRcc:WIST (SPF) from RCC Ltd., Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 12 weeks
- Weight at day 1 treatment: 181.9-191.4g
- Fasting period before study: yes, for approximately 18 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
- Housing: Standard laboratory conditions, in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: ad libitum, Pelleted standard Provimi Kliba 3433 rat/mouse mainte-nance diet
- Water: ad libitum, community tap water from Füllinsdorf
- Acclimation period: 6 days, under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: music during daytime light period
IN-LIFE DATES: 2006-04-14 (group 1); 2006-04-16 (group 2)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 120471944705164
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ KG BODY WEIGHT;
DOSAGE PREPARATION (if unusual): dose levels are in terms of the test item as supplied. The dose formulations were made shortly before each dosing occasion using a magnetic stirrer, a spatula and an Ultra-Turraw as homogenizers. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- Single dosing
2000 mg/kg (2 groups) - No. of animals per sex per dose:
- 3 females/group
6 females in total - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Moratility / Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Clinical observations: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded; Body weight: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes, All surviving animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examina-tions were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- Slightly ruffled fur was observed in 5 of the treated animals on the day of testing from 30 minutes to 3 hours after dosing or 2−3 hours or 5 hours after dosing. A hunched posture was observed in two of the animals 3 hours after the treatment and persisted in one of the animals at the 5-hour reading. For the remaining days of the study no clinical signs were observed. One of the animals was absent of clinical signs thourhgout the study.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age with the exception of animal No. 3 in which a very minor (1.3%) body weight loss was observed during the second week of observation.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of TIC2782 (T002907) after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight. Therefore T002907 is not classified based on CLP Regulation.
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