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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 27 Feb 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147 (2000)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals: New Zealand White rabbits
Source: Inhouse Bred (Outbred) New Zealand White rabbits Toxicology Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, INDIA
Number and sex: 3 Male rabbits
Age at treatment: 6-7 months
Date of birth: 30 July 2010
Body weight range at treatment: 2.77 to 2.94 kg
Accl imatization: One rabbit (RB8764) was acclimatized for five days while the other two (RB8765 and RB8766) rabbits were accl imatized for six days under laboratory conditions after physical examination.
Conditions
Animals were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (12-15 air changes/hour). Environment: temperature 21 - 23°C, relative humidity 65 - 67%, with a 12 hour light and 12 hour dark cycle. The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings.
Housing
The rabbits were housed in dividually in rabbit cages (approx. size: L 65 x B 65 x H 45 cm) with Noryl shallow cage body and facilities for pelleted food (Stainless steel feed hopper) and drinking water (750 mL markrolon bottle fitted with sipper tube). The litter collection tray (noryl waste tray) were washed daily with water (except on Sundays). Water was replenished daily. The water bottles and feed hoppers were changed once a week.
Diet: ad libitum
The animals were offered rabbit feed manufactured by Pranav agro Industries Ltd, Sangli.
Specific contaminants (heavy metals organochlorines and organophosphates) in the diet are analysed periodically and the reports are included in the raw data file.
Water: ad libitum
The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cumpurifier manufactured by Eureka Forbes Ltd. , Mumbai - 400 00 I, India. The water bottles were replenished once daiIy and the water bottles changed once a week.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: each rabbit also served as it's own control with untreated areas of the skin.
- Amount / concentration applied:
- Sample preparation
A quantity of 0.5 g of test substance as received was made into paste by adding sufficient volume of water and mixed with a glass rod.
Preparation of Test Animals
Approximately 24 hours prior to treatment, the fur on the left side of the dorsolateral trunk surface [about 14 x 19 cm] was clipped with an electric clipper -Aesculap® - Germany. Care was taken to avoid abrading the skin. After clipping and prior to application, the animal 's skin (test site) was checked for any abnormalities according to the "Primary Skin Irritation Scoring System", and the test site was found to be normal. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days: skin reactions were evaluated 1 hour and then 24, 48 and 72 hours after removal of the patch
- Number of animals:
- 3
- Details on study design:
- Testing Option
The study was initiated in a stepwise procedure (1 + 2 Rabbits).
Test substance Application
Preparation of Dose Site
Approximately 6 cm2 intact test site was selected on each animal. The adjacent untreated skin of each animal served as the control site.
Application of Test Substance
A quantity of 0.5 g of test substance as received was made into paste by adding sufficient volume of water and mixed with a glass rod. The test substance was applied directly to the skin of the test site and covered with a gauze pad. The entire trunk of each animal was then wrapped with non-irritating semiocclusive adhesive tape to avoid dislocation of the patch.
Exposure of Animals
In a stepwise manner (1 +2 rabbits) all the three rabbits were exposed to the test substance each with one test patch only for a four hour exposure period. The rabbits were restrained using Elizabethan collar for 72 hours post application of the test patch.
Toxic Signs and Pre-Terminal Deaths
Rabbits were observed for toxic signs and pre-terminal deaths for the first four hours (at hourly intervals) on the day of test substance application and once daily thereafter till the end of the observation period.
Body Weights
Individual body weights of the rabbits were recorded at the start of acclimatization, day 1 of treatment (just before test substance application) and
at the termination of observation.
Skin Scoring
Following the exposure period, test patches were removed and the application sites were washed with water and clean towels to remove any residual test substance. The 4 hour dose sites were examined for signs of erythema and edema within 60 minutes and at intervals of approximately 24, 48 and 72 hours after test patch removal accord ing to the "Primary Skin Irritation Scoring System" developed by Draize.
Individual skin scores were recorded for each rabbit.
Grading of skin reactions
The skin reaction was assessed according to the numerical scoring system of Draize et.al (1944).
1. ERYTHEMA AND ESCHAR FORMATION
No erythema.................... . ...................................................................................................................................................................... 0
Very slight erythema (barely perceptible)........................................................................................................................................... 1
Well-defined erythema........................................................................................................................................................................... 2
Moderate to severe erythema.......... .................................................................................................................................................... 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) .......................................................................... 4
MAXIMUM POSSIBLE SCORE - 4
2. EDEMA FORMATION
No edema.................................................................................................................................................................................................. 0
Very sl ight edema (barely perceptible) .............................................................................................................................................. 1
Slight edema (edges of area well defined by definite raising) ......................................................................................................... 2
Moderate edema (raised approximately 1 millimetre).... .................................................................................................................. 3
Severe edema (raised more than 1 millimetre and extending beyond area of exposure)........................................................... 4
MAXIMUM POSSIBLE SCORE - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There were no skin reactions observed In any of the rabbits through the observation period.
- Other effects:
- There were no toxic signs and pre-terminal deaths during the course of the experiment. The body weights of all the rabbits increased through the observation period.
Any other information on results incl. tables
Erythema and edema scores at 1, 24, 48 and 72 hours were 0 for each of the three animals tested.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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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