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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-14 to 2015-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to OECD 402 and EU Method B.3 guideline, in compliance with GLP. No deviations were noted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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- Analytical purity: 50 %- Purity test date: no data- Lot/batch No.: BLW0010057- Expiration date of the lot/batch: 2015-12-01- Stability under test conditions: no data- Storage condition of test material: at approximately 4°C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: 5 male and 5 female Wistar strain rats, RccHan(TM): WIST, supplied by Harlan Laboratories UK Ltd., Oxon, UK. - Age at start of study: 8-12 weeks- Weight at start of the study (day 0): 234 - 272 grams for males, 207 - 223 grams for females - Fasting period before study: no data- Housing: in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. - 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, free access to mains drinking water- 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
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE- Area of exposure: back and flanks of the animals, clipped free of hair- % coverage: approximately 10% of total body surface area- Type of wrap if used: the test item was applied using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. REMOVAL OF TEST SUBSTANCE- Washing (if done): the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied (volume or weight with unit): 3.37 ml/kg- Concentration (if solution): no data- Constant volume or concentration used: yesVEHICLE- no vehicle used
- Duration of exposure:
- 24 hours
- Doses:
- 4000 mg/kg (equivalent to 2000 mg active ingredient/kg body weight)
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: mortality/overt signs: 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days; clinical signs: after removal of the dressings and subsequently once daily for 14 days. The test sites were examined for evidence of primary irritation (erythema and eschar formation and oedema formation). Any other skin reactions were also recorded; individual body weights were recorded prior to application of the test item on day 0 and on days 7 and 14.- Necropsy of survivors performed: yes, at the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necrposy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopical abnormalities was recorded. No tissues were retained.
- Statistics:
- No statistical analysis performed.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: equivalent to 2000 mg active ingredient/kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 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. There were no signs of dermal irritation.
- Body weight:
- Animals showed expected gains in body weight, except for two females which showed body weight loss during the first week but expected gain in body weight during the second week.
- 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 acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 4000 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). Based on the CLP Regulation, the test item is considered not to be classified for acute dermal toxicity.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Kuigi ECHA veebilehe paljud osad on sinu keeles olemas, on see leht osaliselt inglise keeles. Lisateave ECHA mitmekeelsuse kohta.
Tere tulemast Euroopa Kemikaaliameti (ECHA) veebilehele! Internet Explorer 7 (ja varasemad versioonid) ei toeta täielikult seda veebilehte. Uuendage oma Internet Exploreri versiooni.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Lisateave küpsiste kohta.