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Diss Factsheets
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EC number: 439-020-3 | 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:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline conform study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 9-11 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH- 4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. The females received from the 24-OCT-2001 until the 30-OCT-2001 batch no. 73/01, then to the end of the study batch no. 74/01. The male rats received batch no. 74/01. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: 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
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Experimental starting date 21-NOV-2001
Experimental completion date 12-DEC-2001
Delivery of animals 21-NOV-2001 (males and females)
Acclimatization 21-NOV to 27-NOV-2001 (males and females)
Treatment 28-NOV-2001 (males and females , 2000 mg/kg)
Observation 28-NOVto12-DEC-2001
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: yes
- concentration in vehicle: 0.5 g/ml
VEHICLE
- Amount(s) applied: 4 ml/kg bw
- Lot/batch no. (if required): 02938667 - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: for mortality/viability: Daily during acclimatization and twice daily during days 1-15, for weighing: On test days 1 (pre-administration), 8 and 15, for clinical signs: Daily during acclimatization and at least four times (see table of Mortality/Clinical Signs) on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Slight erythema on the back was evident in three males and one female on test day 2 in an other female on test day 2 and 3. All other animals were without clinical signs.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight - Executive summary:
A group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (corn oil) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. Slight erythema on the back was evident in three males and one female on test day 2 additionally in an other female on test day 2 and 3. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
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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