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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Carried out to GLP standards and according to OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
SETAFIX X 11342
Molecular formula:
C22H26O6
IUPAC Name:
SETAFIX X 11342
Test material form:
solid: crystalline
Details on test material:
Yellowish solid
Batch: PP02
Purity: >95%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
Test substance (solid) was ground to a powder prior to weighing.
Controls:
not required
Amount / concentration applied:
72.0+/-0.3mg of test substance was applied.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instiallation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Number of animals or in vitro replicates:
Three animals
Details on study design:
The irritation was assessed according to a numerical scoring system for
Corneal Irritation - Opacity and area
Iris
Conjunctival irritation - redness, chemosis and discharge

Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an opthalmic examination lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours in one animal and 72 hours in the other animals
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
24 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 2 out of 3 animals had a max score of 1 at 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
48 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 2 out of 3 animals had a max score of 1 at 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Corrosion: There was no evidence of ocular corrosion.

Colouration: No staining of (peri) ocular tissues by the test substance was observed.

Remnants of the test substance were present in the eyes of all animals on day 1.

Toxicity/ mortality: No symptoms of sytemic toxicity were observed in the animals during the test period and no mortaility occured.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

Based on these results and according to the EC criteria for classification and labelling requirments for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.