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Diss Factsheets
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EC number: 452-810-2 | 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:
- 2003-08-26 to 2003-09-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP compliant study, performed according to OECD guideline 423 and EU method B1 tris. No deviations were recorded.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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
- Details on test material:
- - Name of test material (as cited in study report): T002251
- Substance type: brown powder
- Physical state: solid
- Analytical purity: 96%
- Purity test date: no data
- Lot/batch No.: 00410155
- Expiration date of the lot/batch: 2004-05-05
- Stability under test conditions: unknown in PEG300
- Storage condition of test material: in the original container, at room temperature (range of 20+/-3°C), away from direct sunlight
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HanBrl:Wist (SPF) from RDD Ltd., Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 12 weeks
- Weight at treatment (day 1): 180.8-189.3g
- Fasting period before study: for approx 17 to 18 hours (access to water was permitted). Food was provided again 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 maintenance diet
- Water: ad libitum, community tap water from Füllinsdorf
- Acclimation period: at least 6 days, under laboratory conditions, after health examination. Only animals without 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 the light period
IN-LIFE DATES: From: 2003-09-02 (group 1), 2003-09-04 (group 2)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:0.2 g/ml
- Amount of vehicle (if gavage): 10ml/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 448174/1 21203148
- Purity: not known
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg bw
DOSAGE PREPARATION:
Dose levels are in terms of the test item as supplied by the sponsor. The dose formulations were made shortly before each dosing occasion using a magnetic stirrer as homogenizer. The test item was weighter 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 durig 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: mortality/viability: Daily during acclimatization and twice daily during days 1-15. Weighing: On test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
All 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 sodim pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
clinical signs: Daily during acclimatization and at approximately 0, 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalilties were recorded. - Statistics:
- No statistical analyses were 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 occured during the study.
- Clinical signs:
- Slightly ruffled fur was observed in two animals at the 1- and 2-hour reading and in four animals form the 0-hour to the 5-hour reading and persisted in three animals up to test day 5. Hunched posture was noted in three animals form the 2- or 3-hour to the 5-hour reading. Three animals showed ventral recumbency from the 0-hour to the 1- or 2-hour reading and one animal was seen with slight sedation from the 0-hour to the 3-hour reading.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No marcoscopic findings were recored at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of T002251 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 T002251 is not classified based on CLP regulation.
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.
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