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Diss Factsheets
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EC number: 939-180-9 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Reference substance name:
- Reaction products of imine and acrylate
- Molecular formula:
- Not applicable. UVCB substance
- IUPAC Name:
- Reaction products of imine and acrylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Age at study initiation: Five 8-week-old males and five 10-week-old females were used in the experiment.
- Weight at study initiation: Five males with the average body weight of 292.6 g and five females with the average body weight of 268.4 g were used in the experiment.
- Housing: The rats will be kept in cages with a plastic bottom and wire bar lids. The dimensions of the cages will be as follow: (length x width x height) 58 x 37 x 21 cm. UV-sterilized wood shavings will be used as bedding. Following the administration of the test material on the animals’ skin, each one will be kept individually in one cage. After the removal of the test material from the animals’ skin, i. e. on the following days of the experiment, the rats will be kept at five per cage, each sex separately.
- Diet (e.g. ad libitum): standard granulated fodder “Murigran", ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): 40 – 70%
- Air changes (per hr): 12 hours light – 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30-45cm2
- % coverage: 10%
- Type of wrap if used: The test item will be applied evenly to gauze patches moistened with a few drops of water and then laid on the prepared skin. The gauze patches will be covered with PVC foil and then, an elastic bandage will be used to make a circular band protecting the patch and the test item.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The residual test item will be removed using water.
- Time after start of exposure: The test item will be in contact with skin for 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The evaluation of a general condition of the animals, i.e. the observation of all animals for mortality and morbidity will be conducted twice a day and once a day (on days off). After the administration of the test item, detailed clinical observations will be performed at hourly intervals on the administration day (day 0) up to the 5th hour. From the 1st to the 14th day of the observation period detailed clinical observations will be performed once a day. The observations will comprise: changes in the skin, hair, eyes and mucous membranes, respiratory system, circulatory system, autonomic and central nervous system, somatic activity, and behavior.
Body weight of the animals will be determined individually for each animal directly before the administration of the test item (day 0) and then on the 7th and the 14th day before killing the animals.
- Necropsy of survivors performed: yes
The rats which die spontaneously during the experiment will be subjected to a gross necropsy. All rats which survive the period of the experiment will be humanely killed after a 14-day observation period by a peritoneal administration of morbital at a dose of 200 mg/kg b.w. and subjected to a post mortem examination. A detailed gross examination of the external body surfaces, all apertures, cranial, thoracic and abdominal cavities with their content will be performed at necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the period of the experiment.
- Clinical signs:
- other: Following a single application of the test item, the animals did not show any general clinical signs.
- Gross pathology:
- During the gross examination no pathological changes were observed in the animals.
- Other findings:
- No pathological changes on the animals’ skin in the site of the test item application were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value was determined to be greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity study will be conducted in compliance with the OECD Guideline for the Testing of Chemicals No. 402 (1987): Acute dermal toxicity and the EU Method B.3.: Acute toxicity (dermal).
A group of five Sprague-Dawley male and female rats was exposed dermally to a dose level of 2000 mg/kg bw. All animals survived the period of the experiment.
The dermal LD50 value was determined to be greater than 2000 mg/kg bw.
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