Registration Dossier

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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test conducted prior to the GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: FDA of the United States
Version / remarks:
FDA of the United States (Fed. Reg .28 (119), 5582 1963)
Qualifier:
according to guideline
Guideline:
other: Draize and Kelley
Version / remarks:
Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
GLP compliance:
no
Remarks:
Test conducted prior to the GLP guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethyloct-7-en-2-yl acetate
EC Number:
258-751-7
EC Name:
2,6-dimethyloct-7-en-2-yl acetate
Cas Number:
53767-93-4
Molecular formula:
C12H22O2
IUPAC Name:
2,6-dimethyloct-7-en-2-yl acetate
Test material form:
liquid
Specific details on test material used for the study:
Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand White albino rabbits are used for each test substance. The animals are cages individually and receive no hay or other extraneous materials that might enter the eyes.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 ml of undiluted test material
Duration of treatment / exposure:
instillation
Observation period (in vivo):
The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Duration of post- treatment incubation (in vitro):
none
Number of animals or in vitro replicates:
Six New Zealand White albino rabbits

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:
4
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
mean of 2 animals
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hr scored
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritant / corrosive response data:
DHMA caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up.

Any other information on results incl. tables

An animal is considered as giving a positive reaction if there is, at any of the reading, discernible opacity of the cornea or inflammation of the iris (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection) or if such susbtance produces in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with the partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale is used.

Applicant's summary and conclusion

Interpretation of results:
other: not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.
Executive summary:

The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter 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 the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.

Categories Display