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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:
- April 25, 2007 - May 09, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study conform with Directive 2004/73/EC, B.4, OECD Guideline No. 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Test system: Young Adult New Zealand White Rabbit, SPF
Rationale: Recongnized by the international guidelines as the recommended test system.
Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands Postbus 6174, NL-5960 AD
Horst / The Netherlands
See also information below "Details on test animals"
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Test system: Young Adult New Zealand White Rabbit, SPF
- Number of animals per test: 3 (Animals of both sexes were used)
- Age at treatment: 13 weeks (male), 12, 14 weeks (females)
- Identification: By unique cage number and corresponding ear number.
- Acclimatization: Under laboratory conditions after health examination. only animals without any visual signs of illness were used for the study.
- Allocation: Male No. 61, Female Nos. 62, 63
- Weight at study initiation: No data
- Housing: Individual in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C (Air-conditioned)
- Humidity (%): 30-70% , 10-15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark
Music was played during the daytime light period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g/ animal
- Duration of treatment / exposure:
- 1-and 4 hours
- Observation period:
- 1, 24, 48 and 72 hours, as well as 7 days after exposure.
- Number of animals:
- 3 (Animals of both sexes were used)
- Details on study design:
- TREATMENT:
Four days before treatment, the left and /or right flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x
10 cm). The skin of the animals was examined one day prior to test item administration and re-grown fur was clipped on the selected application site.
On the day of treatment, 0.5 g of AES was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of
the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 1- and 4 hours, respectively. Then the dressing was removed and the skin was flushed with lukewarm tap water to
clean the application site so that any reactions (erythema) were clearly visible at that time.
OBSERVATIONS.
Viability/Mortality and Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SKIN OBSERVATION TIME POINTS AND TERMINATION:
The skin reaction was assessed at approximately 1, 24 , 48 and 72 hours, as well as 7 days after exposure (removal of the dressing, gauze patch and test item).
NECROPSY:
All rabbits were sacrificed by an intravenous injection of Pentobarbitone into the ear vein at a dose of at least 1 mL/kg body weight (equivalent to 16mg sodium pentobarbitone/kg body weight) and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4- hours exposure
- Score:
- 0 - 0.33
- Max. score:
- 0.67
- Reversibility:
- fully reversible
- Remarks on result:
- other: no longer evident 72 hours or 7 days after treatment.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4-hour exposure
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No abnormal findings were observed on the treated skin of any animal 7 days after treatment, the end of the observation time.
Neither alterations of the test item of the treated skin was observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed.
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Base upon the referred classification criteria (commission Directive 2001/59/EC of August 2001), AES is considered to be "Not Irritation" to rabbit
skin. - Executive summary:
The mean score was calculated across 3 scoring time for each animal for erythema/eschar grades and for oedema grades, seperately. The erythema / eschar score after 1- hour exposure in one animal was 1.00 and the oedema score was 0.00. The mean erythema/eschar score after a 4- hours exposure in the three animals was 0.33, 0.67 and 0.00, respectively and mean oedema score was 0.00 for each of the three animals.
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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