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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:
From July 2nd to July 29th, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted February 24th, 1987
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Yellow 6314-PPT
IUPAC Name:
Yellow 6314-PPT
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g into one eye
Duration of treatment / exposure:
Due to the severity of the ocular reactions observed at the 24-hour examination, all treated eyes were rinsed with 0.9 % saline.
Observation period (in vivo):
1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application.
Number of animals or in vitro replicates:
3 animals (1 male and 2 females).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Corneal opacity, changes in the iris, conjunctivae redness and chemosis were fully reversible within 14 days. Slight to moderate redness of the sclerae was fully reversible within 21 days.
Other effects:
VIABILITY/MORTALITY AND CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

COLORATION
No staining of the treated eyes by the test item was observed.

CORROSION
No corrosion of the cornea was observed at any of the reading times.

BODY WEIGHTS
One of the animals showed a slight body weight loss (4.4 %) during the acclimatization period. There was no obvious reason for this weight loss and it is considered to be incidental. The body weights of all other rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: eye irritant (Category 2), according to the CLP Regulation (EC 1272/2008)
Conclusions:
Eye irritant.