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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(isodecyloxy)propiononitrile
EC Number:
264-840-1
EC Name:
3-(isodecyloxy)propiononitrile
Cas Number:
64354-92-3
Molecular formula:
C13H25NO
IUPAC Name:
3-(decylalkyl-(branched)oxy)-propiononitrile

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: New Zealand albino rabbit
Origin: Chartes River Deutschland GmbH; Stolzenseeweg 32 - 36; 88353 Kißlegg
Number of animals: 3
Body weight at start of the study: 3.1 - 3.9 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20 ±3°C
Relative humidity: 50±20 %
Lighting time: 12 hours daily
Acelimatization: 1 week under study eonditions
Food: ssniff' K-H (V2333), ad libitum and hay (approx. 15g daily)
Water: water from automatie water dispensers, ad libitum
Animal identifieation: numbered ear tags

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml per eye
Duration of treatment / exposure:
24h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

0.1 ml Isodecylethernitril was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for cornealiesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in comea, iris or conjunctivae were graded numerically.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour after application the conjunctivae the animals showed a diffuse crimson red up to a diffuse beefy red colour and very slight swellings. Additionally, clear·colourless eye discharge was noted. 24 hours after application a diffuse crimson colour of the cunjuntivae were observed in two anima/so 48 hours after application all signs of irritation were reversible.

Based on the individual scores after 24, 48 and 72 hours, the following mean values
were calculated:
Opacity of cornea all animals 0.0 Iris all animals 0.0
animal 39 0.0 animal 39 0.0
animal 83 0.0 animal 83 0.0
animal 87 0.0 animal 87 0.0
Redness of conjunctiva all animals 0.44 Chemosis of conjunctiva all animals 0.0
animal 39 0.00 animal 39 0.0
animal 83 0.66 animal 83 0.0
animal 87 0.66 animal 87 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing of Isodecylethernitril for primary eye irritation in the rabbit showed, that the substance is practically not irritating to eye.
Executive summary:

Testing of Isodecylethernitril for primary eye irritation in the rabbit showed, that the substance is practically not irritating to eye.