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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
Study period:
November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed equivalent to OECD 405 guideline. Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited details on animals and environmental conditions.
Principles of method if other than guideline:
The techniques of tests as published by the FDA of the US (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) are followed.
GLP compliance:
no
Remarks:
not present at the time of performance.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
EC Number:
255-138-6
EC Name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
Cas Number:
40910-49-4
Molecular formula:
C14H26O2
IUPAC Name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Elintaal F
- Description: Clear colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Adult animals
- Weight at study initiation: no data
- Housing: individually housed

ENVIRONMENTAL CONDITIONS
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
Single instillation on day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 24, 48 and 72 hours and 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
6
Details on study design:
STUDY DESIGN
0.1 mL of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): No

OBSERVATIONS
The eyes of each animal were examined approximately 24, 48 and 72 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, #2, #3, #4, #5 and #6
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2, #3, #4, #5 and #6
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs.
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #2 and #6
Time point:
other: 24, 48 and 72 hrs.
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #3, #4 and #5
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1, #2, #3, #4, #5 and #6
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritant / corrosive response data:
Elintaal F caused slight redness of the conjunctivae in 3 out of 6 rabbits. The effects were fully reversible after 7 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, Elintaal F caused slight redness of the conjunctivae in 3 out of 6 rabbits. The effects were fully reversible after 7 days.

Executive summary:

Elintaal F was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.

The test substance caused slight redness of the conjunctivae in 3 out of 6 rabbits. The effects were fully reversible after 7 days.

Based on the results, Elintaal F does not have to be classified and has no obligatory labelling requirement for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.