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EC number: 805-561-2 | CAS number: 350601-49-9
- 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:
- 28 December 2012 to 5 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: Variable coloured powder
- Storage conditions of the test material: Ambient (18 to 36 °C)
- pH: The pH of the test material as a 10 % aqueous solution was 5.05
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 8 months
- Weight at study initiation: 2.61 to 2.72 kg
- Fasting period before study: No
- Housing: The rabbits were housed individually in rabbit cages (size: approximately 65 cm long x 65 cm deep x 45 cm high) with a noryl shallow cage body and facilities for pelleted feed and drinking water. The litter collection trays (noryl waste tray) were changed daily (except on Sundays). A noryl perforated raised shelf was provided to the animals for enrichment.
- Diet (e.g. ad libitum): Rabbit feed was provided ad libitum in a stainless steel feed hopper.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in a water filter-cum-purifier was provided to animals ad libitum in 750 mL bottles with sipper tubes. The water in the bottles was replenished once daily and the water bottles were changed once a week.
- Acclimation period: Five days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 65 to 66 % (relative)
- Air changes (per hr): 12 to 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours of light and 12 hours of dark
IN-LIFE DATES: From: 28 December 2012 To: 05 January 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material was made into a paste with Milli-Q water
- Controls:
- other: The adjacent untreated skin of each animal served as the control site.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): The test material was made into a paste by moistening with 0.25 mL of Milli-Q water. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: An approximately 6 cm² intact test site was selected on each animal on the left dorsolateral trunk surface. Approximately 24 hours before treatment, the fur (about 14 x 19 cm) was clipped with an electric clipper and care taken to avoid abrading the skin. After clipping and prior to application, the test site was checked for any abnormalities according to the “Primary Skin Irritation Scoring System”; all the test sites were found to be normal.
- Type of wrap if used: The test material paste was applied on 6 ply cotton gauze (2 x 3 cm). The entire trunk of each animal was then wrapped with non-irritating semi-occlusive adhesive tape to avoid dislocation of the patch. Each rabbit was restrained using an Elizabethan collar for 4 hours post application of the test patch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test patches were removed and the test sites were washed with de-ionised water to remove any residual test material.
- Time after start of exposure: Following the 4 hour exposure period.
SCORING SYSTEM:
The test sites were examined for signs of erythema and oedema within 60 minutes and at intervals of approximately 24, 48 and 72 hours after test patch removal according to the "Primary Skin Irritation Scoring System" developed by Draize, et al. (1944).
OBSERVATIONS
- Clinical Observations: The rabbits were observed for clinical signs of toxicity and mortality 4 times (at hourly intervals) on the day of test material application and once daily thereafter until the end of the observation period.
- Body Weights: Body weights were recorded at the start of acclimatisation, day 1 of treatment (just before test material application) and at termination of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The erythema score was 0 at every time point for each animal
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The oedema score was 0 at every time point for each animal
- Irritant / corrosive response data:
- There were no skin reactions observed in all three rabbits at 1, 24, 48 and 72 hours post removal of the 4-hour test patch.
- Other effects:
- There were no clinical signs of toxicity observed, and none of the animals died, during the course of the study.
The body weight of all three rabbits increased throughout the observation period. See Table 1.
Any other information on results incl. tables
Table 1: Body Weight
Rabbit Number |
Body weight (kg) |
||
At start of acclimatisation |
At treatment |
At termination of observation |
|
RB9678 |
2.53 |
2.61 |
2.70 |
RB9679 |
2.63 |
2.70 |
2.73 |
RB9680 |
2.65 |
2.72 |
2.76 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material caused no irritation to the skin of male New Zealand White rabbits and requires no classification in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause skin irritation/corrosion in male New Zealand White rabbits was assessed in accordance with the standardised guidelines OECD 404 and US EPA OPPTS 870.2500 under GLP conditions.
0.5 g of the test material was made into a paste with 0.25 mL of Milli-Q water and applied to the clipped, intact skin of 3 animals in a semi-occlusive fashion for 4 hours.
The degree of irritation was evaluated and scored according to the Draize (1944) scale at 1, 24, 48 and 72 hours following removal of the test patch.
There were no clinical signs of toxicity or mortality and all animals gained weight. Neither erythema nor oedema was noted during the observation period under the conditions of the study.
Under the conditions of this study, the test material caused no irritation to the skin of male New Zealand White rabbits and requires no classification in accordance with EU criteria.
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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