Registration Dossier

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: GLP study according to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch 939-76

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
animal: 9529
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
animal: 9537
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
animal: 9533
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 9529
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 9537
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 9533
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal: 9529
Time point:
other: 24, 48, 72 hour reading
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal: 9537
Time point:
other: 24, 48, 72 hour reading
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal: 9533
Time point:
other: 24, 48, 72 hour reading
Score:
1.33
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 9529
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 9537
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 9533
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
animal: 9529
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
animal: 9537
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
animal: 9533
Time point:
other: 24, 48, 72 hour reading
Score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item ANTHRANILIC ACID-AAOA, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which was reduced at 24 hours afer application. The effects were fully reversible within 72 hours. According to directive 2001/59/EC, ANTHRANILIC ACID-AAOA does not require classification as an eye irritant.
Executive summary:

The acute eye irritation study of the test item ANTHRANILIC ACID-AAOA was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eyes served as control. 0.1 g of the test item was used for the study in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48, 72 hours after the application. The untreated right eye served as control. One hour after the single application of test item ANTHRANILIC ACID-AAOA into the eye of the rabbits, conjunctival redness (severity 3) and discharge (severity 3) were observed in all animals. At 24 hours after treatment conjunctival redness was observed in all animals (severity 2 in two animals and severity 3 in one animal). At 48 hours after the treatment conjunctival redness (severity 1) was observed in all animals. At 72 hours after treatment all animals were symptom-free. During the study the control eye of animals were symptom-free. There were no mortality or systemic clinical changes related to ANTHRANILIC ACID-AAOA administration in rabbits observed at the animal general examination performed daily. Body weight values of ANTHRANILIC ACID-AAOA-treated animals measured at termination of study showed normal changes compared to the pre-treatment values. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows: chemosis : 0.00, 0.00, 0.00 discharge : 0.00, 0.00, 0.00 redness : 1.00, 1.00, 1.33 cornea opacity : 0.00, 0.00, 0.00 iris : 0.00, 0.00, 0.00 The test item ANTHRANILIC ACID-AAOA, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which was reduced at 24 hours afer application. The effects were fully reversible within 72 hours. According to directive 2001/59/EC, ANTHRANILIC ACID-AAOA does not require classification as an eye irritant.