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Diss Factsheets

Administrative data

Endpoint:
eye irritation
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:
2004
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

Constituent 1
Reference substance name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
EC Number:
946-247-6
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic 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).
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.