Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
No purity of test substance reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
not applicable
Qualifier:
according to guideline
Guideline:
other: Journal Officiel de la Republique Francaise 1971/1973
Deviations:
not specified
Principles of method if other than guideline:
Study was conducted prior to adoption of any OECD guidelines.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylene dinonanoate
EC Number:
255-350-9
EC Name:
Propylene dinonanoate
Cas Number:
41395-83-9
Molecular formula:
C21H40O4
IUPAC Name:
1-(nonanoyloxy)propan-2-yl nonanoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: about 2.5 kg at study start
Animals were vaccinated against myxomatosis and selected only if normal eye condition; any rabbits with ocular lesions were excluded.
- Housing: Individual cages (600x540x315 mm) or restraining devices
- Diet: 200 g commercial rabbit feed per day in the form of granules
- Water: ad libitum
- Climate: air conditioned

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, each animals untreated right eye served as control
Amount / concentration applied:
0.1 mL of undiluted test substance as supplied by sponsor was instilled to the left eye.
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Readings were after 1, 24, 48, 72 hours, and 4 and 7 days after administration
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
No rinsing of eyes was done.

SCORING SYSTEM:
Chemosis: Scores 0-4
Conjunctival enanthema: Scores 0-3
Iris: Scores 0-2
Corneal opacity: Scores 0-4

TOOL USED TO ASSESS SCORE: ophtalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal: #1, #3, #6
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #4, #5
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, 5#, #6
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #6
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3, #5, #6
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #4
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Other effects:
No mortality occurred during this study.

Any other information on results incl. tables

 

 

Animal #

 

 

 

 

 

 

Reading time [hour]

#1

#2

#3

#4

#5

#6

Chemosis

24

0

1

0

0

0

1

Chemosis

48

1

1

1

0

0

0

Chemosis

72

0

0

0

0

0

0

 

Individual mean

0.33

0.67

0.33

0.0

0.0

0.33

Redness conjunctivae

24

1

0

1

0

1

1

Redness conjunctivae

48

0

0

0

0

0

0

Redness conjunctivae

72

0

0

0

0

0

0

 

Individual mean

0.33

0.0

0.33

0.0

0.33

0.33

Iris

24

0

0

0

0

1

0

Iris

48

0

0

0

0

0

0

Iris

72

0

0

0

0

0

0

 

Individual mean

0.0

0.0

0.0

0.0

0.33

0.0

Cornea opacity

24

0

0

0

0

0

0

Cornea opacity

48

0

0

0

0

0

0

Cornea opacity

72

0

0

0

0

0

0

 

Individual mean

0.0

0.0

0.0

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.