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Diss Factsheets
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EC number: 465-100-2 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of animals and sex: 8 males and 8 females (range-finding and main study). Females were nulliparous and non-pregnant.
Age: Young adult animals, approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
Body weights: For each sex, body weight variation did not exceed ± 20 % of the mean.
Health conditions: A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
Hygienic status: Optimal hygienic conditions.
Room temperature: Average of 22 °C (continuous control and recording).
Relative humidity: Average of 54 % (continuous control and recording).
Air exchange: 12 per hour.
Light Artificial light: from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips, type "ABEDD", (Fa. ABEDD Dominik Mayr KEG,
A-8580 Köflach), autoclaved. Bedding material was changed weekly. Samples of the bedding material are checked periodically for contaminants by the supplier.
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material,
(same source and material as the bedding material), were offered to the animals once a week.
Feed Altromin 1324 forte, (Producer: Altromin GmbH, D-32791 Lage) gamma irradiated with 25 kGy 60Co, ad libitum. Random samples of the feed are analysed for contaminants by Altromin.
Water: Tap water from an automatic watering system, ad libitum. Random samples of the water are analysed to check, if the water fulfils the requirements for drinking water for humans (exception: the pH).
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acclimatisation: 5 days under laboratory conditions.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape. Patch and
- Details on dermal exposure:
- "STI571 F8", was administered once dermally on an area of approximately 6.5 cm x 8 cm on the dorsal thoracal region of 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg per kg body weight.
A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape. Patch and tape were covered with a semi-occlusive dressing The duration of the exposure was 24 hours. - Duration of exposure:
- 24 h
- Doses:
- The dose was 2000 mg per kg body weight.
- Control animals:
- no
- Details on study design:
- Investigations
• Body weights: before the administration, 7 and 14 days after the administration (p.a.).
• Clinical observations: at least once per day.
• Necropsy: A macroscopic examination was performed after terminal sacrifice
(14 days p.a.).
Observations were performed 0 - 0.5, > 0.5 - 1, > 1 - 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
No skin examination of the administration site was possible during the exposure period, while
it was covered by the patch and wrappings.
All animals were killed by inhalation of 80 % CO2 + 20 % O2 14 days p.a. and subjected to a
necropsy including a gross pathological examination.
Results and discussion
- Preliminary study:
- In a range finding study three groups of one male and one female each were dosed with 400,
894 or 2000 mg per kg body weight. All animals survived for 7 days p.a. Therefore a limit-test
with one dose of 2000 mg per kg body weight was performed.
Both animals, dosed with 2000 mg/kg in the preliminary test, were included into the main
study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
All animals survived until the scheduled termination of the study. - Clinical signs:
- other: Signs of toxicity related to dose levels: Three females showed a low weight gain during the first week of study and one of these continued to show a low weight gain during the second week of the study.
- Gross pathology:
- Effects on organs: No test substance related effects.
General findings: All animals were normal during the entire observation period.
Observations of skin condition: Exposed skin was not found to be altered by the test
substance.
All animals were normal at terminal necropsy.
No noteworthy sex difference in the response to the test substance was derived from clinical
observations or post-mortem findings. - Other findings:
- Signs of toxicity (local):
No test substance related effects.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Cat 5 for GHS, Not classified for CLP
- Conclusions:
- Acute dermal toxicity study in rats, animals were administered 2000 mg/kg of STI571 F8 in a single dermal administration performed by spreading the undiluted test substance on an area of at least 10 % of the estimated body surface. All animals were normal during the entire observation period. Observations of skin condition: Exposed skin was not found to be altered by the test
substance. All animals survived until the scheduled termination of the study.The LD50,dermal of "STI571 F8" is higher than 2000 mg/kg body weight in 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.
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