Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-04-23 to 2014-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to OECD TG 420 and EC B.1.bis guideline, in compliance with GLP. No deviations were noted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): XTA 823- Substance type: yellow slightly viscous liquid- Physical state: liquid- Purity (solids content): 49.8%- Purity test date: no data- Lot/batch No.: BLW060113- Expiration date of the lot/batch: not supplied- Stability under test conditions: no data- Storage condition of test material: at room temperature in the dark-Other: - Production date: 2014-10-02
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: 6 female Wistar strain rats, RccHan (TM):WIST; supplied by Harlan Laboratories UK Ltd., Oxon, UK- Age at study initiation: 8-12 weeks (nulliparous and non-pregnant)- Weight at start of study: 166 - 180 grams - Fasting period before study: overnight immediately before dosing until approximately 3 to 4 hours after dosing- Housing: in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.- Diet (e.g. ad libitum): ad libitum, 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK- Water (e.g. ad libitum): ad libitum- The diet, drinking water and bedding were routinely analyzed and were considered no to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study. - Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 25 °C- Humidity (%): 30 - 70%- Air changes (per hr): at least 15 changes per hour- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 30 mg/ml- Amount of vehicle (if gavage): 10 ml/kg- Justification for choice of vehicle: no data- Lot/batch no. (if required): no data- Purity: no dataMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg (dose of 300 mg/kg), 1.70 ml/kg (dose of 2000 mg/kg)DOSAGE PREPARATION (if unusual):- For the purpose of the 2000 mg/kg dose level the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. - For the purpose of the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in distilled water.- The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration. - No analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation. This exception is considered not to affect the purpose or integrity of the study.
- Doses:
- 300 - 2000 mg/kg (50% solution)
- No. of animals per sex per dose:
- 1 animal at 300 mg/kg5 animals at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: clinical observations: 1/2, 1, 2 and 4 hours after dosing and then daily for 14 days; morbidity and mortality: twice daily; individual body weights: recorded on day 0 (the day of dosing) and on days 7 and 14- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities recorded. No tissues were retained.
- Statistics:
- No statistical analysis performed.
Results and discussion
- Preliminary study:
- Dose level - 300 mg/kg:- Mortality: there was no mortality.- Clinical observations: no signs of systemic toxicity were noted during the observation period.- Body weight: the animal showed expected gains in body weight over the observation period.- Necropsy: no abnormalities were noted at necrospy.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (equivalent to greater than 1000 mg active ingredient/kg bw). Based on CLP Regulation, the substance is considered to not be classified.
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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