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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
propylene dinonanoate

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.