Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study design states it complies and it follows lates OECD guideline 404 (1981). Contains sufficient detail to suggest GLP-like characteristics even though no statement of certification is reported (reasonably thorough description of authors, dates, design, results, and interpretation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Appraisal of the safety of chemicals in food, Drugs and Cosmetics by the staff of the division of pharmacology, FDA
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Code of Draize (1959)
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
version of May 1981
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Atrazine technical
Appaerance: white powder
Supplier: OXON Italia S.p.A.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six adult female white New Zealand were used for this procedure. They were 6 to 8 months old with body weights about 3.0 Kg. They were housed in individual cages at a laboratory standard diet for rabbits and were watered ad libitum. the room temperature was kept constantly at ca 18°C (max. limit), the relative atmospheric humidity 50 to 60%, and the daily illumination 12 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g of the substance to be tested were installed into one eye of each animal.
Duration of treatment / exposure:
7 days
Observation period (in vivo):
Ocular lesions were read 1h, 2h, 4h, 8h, 24h, 2d, 3d, 4d, 5d, 6d, 7d after the administration of the test substance
Number of animals or in vitro replicates:
6 albino rabbit (white New Zealand) were used for the test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1,#2,#3,#4,#5,#6
Time point:
other: 1h, 2, 4h, 8h, 24h, 2d, 3d, 4d, 5d, 6d, 7d
Score:
0
Max. score:
0
Remarks on result:
other: Degree of opacity
Irritation parameter:
cornea opacity score
Basis:
animal: #1,#2,#3,#4,#5,#6
Time point:
other: 1h,2h,4h,8h,24h,2d,3d,4d,5d,6d,7d
Score:
0
Max. score:
0
Remarks on result:
other: Area of opacity
Irritation parameter:
iris score
Basis:
animal: #1,#2,#3,#4,#5,#6,#7
Time point:
other: 1h,2h,4h,8h,24h,2d,3d,4d,5d,6d,7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2,#3,#4,#5,#6
Time point:
other: 1h,2h,4h,8h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Reddening of the palpebral conjunctiva
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2,#3,#4,#5,#6
Time point:
other: 24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Remarks on result:
other: Reddening of the palpebral conjunctiva.
Irritation parameter:
chemosis score
Basis:
animal: #1,#3,#5#6
Time point:
other: 1h,2h,4h,8h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1h,2h,4h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1h,2h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4h
Irritation parameter:
chemosis score
Basis:
animal: #1,#3,#5,#6
Time point:
other: 24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 8h,24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4h,8h,24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2,#5
Time point:
other: 1h,2h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4h
Remarks on result:
other: lachrymation
Irritation parameter:
conjunctivae score
Basis:
animal: #1,#2,#5
Time point:
other: 4h,8h,24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Remarks on result:
other: lachrymation
Irritation parameter:
conjunctivae score
Basis:
animal: #3,#4,#6
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2h
Remarks on result:
other: lachrymation
Irritation parameter:
conjunctivae score
Basis:
animal: #3,#4,#6
Time point:
other: 2h,4h,8h,24h,2d,3d,4d,5d,6d
Score:
0
Max. score:
0
Remarks on result:
other: lachrymation

Any other information on results incl. tables

Summary of ocular lesions:

 

hours

days

Animal No.

1

2

4

8

24

2

3

4

5

6

7

1

6

6

4

4

0

0

0

0

0

0

0

2

6

6

4

2

0

0

0

0

0

0

0

3

6

4

4

4

0

0

0

0

0

0

0

4

6

4

2

2

0

0

0

0

0

0

0

5

6

6

4

4

0

0

0

0

0

0

0

6

6

4

4

4

0

0

0

0

0

0

0

mean

6

5

3.7

3.3

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: ETAD SUBCOMMITTEE FOR TOXICOLOGY
Conclusions:
The substance Atrazine technical was treated undiluted (as powder) in a primary irritation test in rabbit eyes.
under the described conditions of the experiment it was found:
1. The conjunctival irritations of the first 12 hours disappeared after 24 hours.
2. according to the code of evaluation by ETAD SUBCOMMITTEE FOR TOXICOLOGY the substance is valuated as "non irritant"