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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid Navy RN-2682
IUPAC Name:
Acid Navy RN-2682
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:
100 mg
Duration of treatment / exposure:
No rinse after application.
Observation period (in vivo):
1, 24, 48, 72 h after administration as well as 7 and 10 d.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 10 d
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 10 days
Other effects:
No clinical signs of systemic toxicity were observed and no mortality occurred.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Due to a moderate black staining of the test item, the cornea as well as the conjunctivae and the sclerae were not assessable 1 hour after instillation. When assessable, no local reactions
were observed in the cornea. However, a slight swelling (chemosis) was noted in two animals at the 1-hour evaluation which persisted up to the 24-hour reading in all three animals. A slight to moderate reddening of the conjunctivae was noted in the three animals 24 hours after treatment,
which persisted as slight up to the 48- or 72- hour reading or up to test day 7 in all animals, respectively.
Furthermore, all animals expressed a moderate reddening of the sclerae 24 hours post treatment which persisted as slight up to 48 or 72 hours in both females, respectively.
Moderate ocular discharge was noted in all animals 1 hour after instillation which persisted as slight up to the 24- hour reading in two animals. No abnormal findings were observed in the treated eye of any animal 10 days after treatment, the end of the observation period for all animals.

A moderate black staining produced by the test item was observed in all animals at the 1-hour evaluation and persisted as slight up to the 48 or 72 hours.

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

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)

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