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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/01/99-21/02/99
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals
One male albino New Zealand rabbit 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours and until 21 days following
treatment - Number of animals or in vitro replicates:
- One animal
Initially, a single animal was treated. After consideration of the ocular responses produced in the first
treated animal, two additional animals were not treated. - Details on study design:
- Grading of reactions
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment.
NOTE :
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional
observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Irritant / corrosive response data:
- Due to the serious eye damages caused to the first animal, the test was not extended on two other animals.
The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.
- Executive summary:
Test product: SEPIFEEL ONE
Principle of the study:
The aim of the study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after single application of 0.1 g of the test substance as such on eye in 1 rabbit.
The eye irritation reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72h until 21 days, after instillation.
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 21/02/1999
Results
Mean score 24h, 48h and 72h after instillation Conjonctivae Iris Cornea Animals Chemosis Redness 7926 4 3 1.3 2 Conclusion
The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.
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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