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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
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Organisation for Economic Co-operation and Development (1979).
OECD Short-term and Long-term Toxicology Groups, Final Report:
Acute Eye Irritation/Corrosivity, 31 December, p. 40
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
EC Number:
402-990-3
EC Name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
Cas Number:
163702-01-0
Molecular formula:
C26H32O4
IUPAC Name:
Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
Test material form:
solid
Remarks:
Form specified in RSS.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: "Padre Antonio" Mariano breeding center
Weight: 2.000-3.000 Kg.
Quarantine: A week
Diet: Pellets
Water: water
Ad libitum. Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.

Preliminary selection: Animal health conditions are check 24 hours before the test. All animals with irritation or other eye defects are discarded

ENVIRONMENTAL CONDITIONS
Pressure: Atmospheric pressure
Humidity: 55 ± 15% relative humidity
Air changes (per hr): At least 8
Cages: Model 1472 stainless steel cages of the"Tecniplast" company ~ Gazzada - VA - Italy - with automatic washing cycle 10 seconds every 60 minutes

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g/animal applied once
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes of rabbits were examined at intervals of 1-24-48-72 hours from application. In the cases where corneal damage or irritation occurs persistent ocular examination, additional observations were conducted for the purpose of determining the reversibility or irreversibility of any injuries observed.
Number of animals or in vitro replicates:
One group of 6 animals
Details on study design:
The material under examination is instilled in the outer corner of the right eye of each rabbit slightly pushing the lower eyelid apart. After instillation the eyelids are closed and pressed lightly so as to avoid any loss of material. It is the untreated left eye that served as a control.

The eyes of the rabbits were examined in the following order: a) conjunctiva, b) iris, c) cornea. The lesions of the iris and cornea were exami ned either for direct observation and for lighting with ultraviolet lamp (365 nm) later fluorescein instillation.

The severity of injuries is expressed in points, according to the numerical scale illustrated in the annex table 1 (Draize, J. It., Woodward, G. and Calvary, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the skin and Mucous Membranes, J. Pharmacol. Exp. Ther. 82 377-390).

Any other injury not relevant to the cornea, iris or conjunctiva data was also recorded and reported.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance EC 402-990-3 is not classified as an eye irritant under CLP.
Executive summary:

In this guideline study, the substance (EC 402-990-3) is not sufficiently irritant to be classified under CLP criteria.