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Diss Factsheets
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EC number: 920-912-0 | 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:
- 1/02/1999-21/02/1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Test material form:
- solid
- Details on test material:
- name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Constituent 1
- Specific details on test material used for the study:
- Container: plastic flask
Batch n° 98174300
Form: white wax flakes
Storage: dark, Room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals
Three male albino New Zealand rabbits were supplied by the Elevage Charles RIVER (76410 Saint-Aubin-Les-Elbeuf, France).
They were kept during a minimal 5-day acclimatisation period. The day before application of the substance, the weight was superior to 1.8 kg.
Housing
Each animal was kept in an individual box (60 cm x 45 cm x 32 cm) installed in conventional air conditioned.
The environmental conditions were:
- temperature : between 17°C and 23°C
- relative humidity : between 30% and 70%
- lighting time: 12 hours daily
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco delivered by COFNA (37018 TOURS, France)
Drinking: tap water distributed in polypropylene feeding-bottles with stainless steel teat. A sample of water is taken after each technical intervention from the pipes and every 6 months at least and sent for chemicophysical and bacteriological analysis to a specialized control organization.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The test item was applied on an undamaged skin area of one flank of each animal. On the opposite flank, an untreated area served as control.
- Amount / concentration applied:
- 0.5 g for each animal applied moistened with 0.2 ml of distileed water.
- Duration of treatment / exposure:
- during 4 hours
- Observation period:
- The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours and unitl 20 days after removal of the patch.
- Number of animals:
- 3 males
- Details on study design:
- Treatment
Approximately 24 hours before the test, the rabbits’ backs and flanks were shorn, so as to expose an area of skin about 6 cm2.
The test item was applied, as supplied, at 0.5 g, on an undamaged skin area of one flank of each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape.
Grading of reactions
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours until 20 days after removal of the patch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 20 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 20 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 20 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance Sepifeel One was classified among the substances corrosive to the skin.
- Executive summary:
Test product: Sepifeel One Batch 98174300
Principle of the study: The aim of the study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance after single skin application of 0.5 g of test substance previously moistened with distilled water, under semi-occlusive dressing for 4 hours, in 3 rabbits.
The skin irritation reactions (erythema and oedema) were scored 1, 24, 48, 72 hours and until 20 days after patch removal. The test substance was classified in accordance with the EEC 67/548 Directive and its amendments.
Dates of the study: from 01/02/1999 to 21/02/19999
Results:
Mean score 24h, 48h and 72h after application
Animals Erythema Oedema 7926 3.0 2.3 7927 2.7 2.0 7928 3.0 2.7
Conclusion: The test substance is classified among the substances corrosive to the skin.
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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