Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 january 2003 to 29 january 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- as the tested product is not the registered substance.
- Justification for type of information:
- As an ingredient used in a medical device, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 fev 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 29 dec 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: guideline NF EN ISO 10993-10 Biological evaluation of medical devices
- Version / remarks:
- march 1996
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
- Molecular formula:
- Not relevant for a UVCB substance
- IUPAC Name:
- Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
- Test material form:
- liquid
- Details on test material:
- The mixture contains 94.4 % of corn oil oxidised (glycerides, C10-20 and C10-20 unsat, oxidised).
Constituent 1
- Specific details on test material used for the study:
- batch number 192
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 3 animals supplied by the Elevage de Gérome (Quartier Labaste 40260 Linxe - France).
They were kept during a minimal 5 day acclimatation period.During the test, animal weighed between 2.18 and 2.27 kg.
Kept in individual box at a temperature between 19°C and 22°C, and a relative humidity between 40% and 49%.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 1h, 24h, 48h, 72h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- the ocular reactions observed during the study remain slight and only recorded at the conjonctivae level :
- a slight redness 1hour after the instillation of the product and totally reversible between the 4th and the 5th day of the test,
- associated with a slight chemosis 1 hour after the distillation of the product and totally reversible between the 2nd and the 3rd day of the test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritant for the eyes. The classification H319 is not required.
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