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Diss Factsheets
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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-10-08 to 2014-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
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)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- other: liquid
- Details on test material:
- Characteristics: Slightly yellowish liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: CRL:(WI) rats
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age: young adult rats
-Weight: between 213 - 240g
- Controls: no
- Diet: ad libitum, ssniff® SM R/M "complete diet for rats and mice" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany
- Water: ad libitum, tab water
- Acclimation period: 6 days
- Housing: individual caging
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 24.9°C
- Humidity (%): 49 - 63 %
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
- Ventilation: 15-20 air exchanges/hour
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - Method of administration:
The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment.
The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24-hour exposure period.
Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and
secured with adhesive plaster strips on the application site for 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- - 2000 mg/kg bw, the test item was administered as a single dose as supplied by the Sponsor without using any vehicle
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- EXAMINATIONS:
- Clinical signs: on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations
included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity
and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Skin irritation: daily
- Body weights: days 0, 7, and 14
- Post dose observation period: 14 days
- Macroscopic examination: day 14 - Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortalities
- Mortality:
- Test item did not cause mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- No dermal signs were observed after treatment with the test item during the 14-day observation period.
No clinical signs were observed after the treatment with the test item during the 14 day observation period - Body weight:
- There were no effects on body weight in any animal during the study.
- Gross pathology:
- There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw at necropsy.
- Other findings:
- No other findings
Any other information on results incl. tables
No further information
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg body weight in
male and female CRL:(WI) rats. - Executive summary:
An acute dermal toxicity study was performed with the test item in CRL:(WI) rats, in compliance with OECD Guideline No.: 402.
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter.
Body weight was measured prior to dosing on Day 0 and on Days 7 and 14.
Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows.
Mortality: Test item did not cause mortality at the dose level of 2000 mg/kg bw.
Systemic clinical signs : No clinical signs were observed after the treatment with the test item during the 14 day observation period.
Local dermal signs: No dermal signs were observed after treatment with the test item during the 14-day observation period.
Body weight: There were no effects on body weight in any animal during the study.
Necropsy: There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw at necropsy.
Conclusions
The acute dermal median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg body weight in male and female CRL:(WI) rats.
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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