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Diss Factsheets
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EC number: 944-552-9 | 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)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.04.04 - 2000.07.04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Storage temperature of samples, the humidity in the animal holding room, and the time of recording the dermal reactions deviated from what stated in the protocol. None of the deviation is considered to have affected the study outcome.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Storage temperature of samples, the humidity in the animal holding room, and the time of recording the dermal reactions deviated from what stated in the protocol. None of the deviation is considered to have affected the study outcome.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Storage temperature of samples, the humidity in the animal holding room, and the time of recording the dermal reactions deviated from what stated in the protocol. None of the deviation is considered to have affected the study outcome.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: Cream powder (84% w/w)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (MI3 dried)
- Source and lot/batch No.of test material: C202483
- Expiration date of the lot/batch: 2001.05.31
- Purity: 98.4%
- Purity test date: 2001.05.31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < -10 degrees Celcius
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in vehicle (water)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Purified water (Elgastat purifier used)
- Final preparation of a solid: 100mg/ml MI3 in water, pH of 8.0.
FORM AS APPLIED IN THE TEST (if different from that of starting material): solid dissolved in purified water.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabbit (New Zealand White rabbit)
- Sex: male and female
- Age at study initiation: 10 - 14 weeks.
- Weight at study initiation: 2.35 - 2.41 kg
- Housing: Single housed in floor-pens with wood chips bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40 – 80 %
- Air changes (per hr): at least 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: To: at least 10 - 13 days
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of MI3 moistened with water (paste)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- one hour, 24, 48 and 72 hours after removal of patch and dressing.
- Number of animals:
- 3 ( one male and two females)
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm
- % coverage: NA
- Type of wrap if used: Dense elastic gauze bandage (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Light brushing and swabbing with moistened cotton wool
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) one hour, 24, 48 and 72 hours after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No indication of irritation or corrosive response. Individual and group mean values for dermal changes ( Erythema and Oedema) in the tested animals were zero at 0, 24, 48 and 72 hours.
- Other effects:
- No other effects observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the irritation caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of MI3. The study was designed in accordance with OECD guideline method 404. One male and two female rabbits were exposed to a single dose of 0.5mL MI3 applied to 30 x 20 mm area.All animals were killed by an intravenous injection of an overdose of barbiturate at day 4. No reactions were observed following a single semi-occluded, topical application of MI3 to intact rabbit skin for four hours.
- Executive summary:
The Study was conducted to determine the irritation caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of MI3. The study was designed in accordance with OECD guideline method 404, the commission directive 92/69/EEC, Method B4, and the US EPA Health effects test Guidelines OPPTS 870.2500. A single dose of 0.5 mL MI3 that was applied to a 30 x 20 mm area on the clipped dorsum of each of three rabbits, one male and two females. The treated area of skin was covered by a semi- occlusive bandage for 4 hours and assessed for dermal reaction the following three days. All animals were killed by an intravenous injection of an overdose of barbiturate at day 4.
In conclusion, no dermal reactions were observed following a single semi-occluded, topical application of MI3 to intact rabbit skin for four hours.
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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