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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:
25 May 1979 to 22 June 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with Section 162.81 of the Regulations for the Enforcement of the Federal .Insecticide, Fungicide, and Rodenticide Act, (Federal Register , Wednesday, June 25, 1975). No reference to GLP status.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 162.81 of the Regulations for the Enforcement of the Federal .Insecticide, Fungicide, and Rodenticide Act, (Federal Register, Wednesday, June 25, 1975).
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
TVCI B-5909 is a white powder.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Nine New Zealand White rabbits from Plummer's Rabbit Ranch were used in this study. The rabbits were identified individually by means of numbered ear tags, and were acclimated to the laboratory for at least 5 days prior to being dosed.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.73 gram of the test material (weight of volume occupying 0.1 ml )
Duration of treatment / exposure:
Single application.
The treated eyes of 6 rabbits were left unrinsed, the treated eyes of 3 rabbits were rinsed after 30 seconds for 60 seconds with 200 ml of lukewarm tap water.
Observation period (in vivo):
Examinations for gross signs of eye irritation were made at 24 hrs., 48 hrs., and 72 hrs., 4 days and 7 days following application.
Number of animals or in vitro replicates:
9 animals
Details on study design:
1 and 0.25 hours before being dosed, sodium fluorescein (2%) was used in both eyes of each rabbit to assure no corneal opacity was present prior to dosing.
0.73 gram of the test material (weight of volume occupying 0.1 ml) was applied to the right eye of each of the 9 rabbits. The left eyes were untreated and served as controls. The treated eyes of 6 rabbits were left unrinsed, the treated eyes of 3 rabbits were rinsed after 30 seconds for 60 seconds with 200 ml of lukewarm tap water. Examinations for gross signs of eye irritation were made at 24 hrs., 48 hrs., and 72 hrs., 4 days and 7 days following application. Scoring of irritative effects was according to the method of Draize, in which corneal, iris and conjunctival effects are scored separately.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals# 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals# 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals# 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals# 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals# 7-9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals# 7-9
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals# 7-9
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals# 7-9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Non-Rinsed Eyes
Irritative effects noted at the 24-hour reading included mild conjunctival erythema in five rabbits. By the 48-hour reading and throughout the rest of the study no irritative effects were noted.
Rinsed Eyes
Irritative effects noted at the 24-hour reading included mild conjunctival erythema in one rabbit. By the 48-hour reading and throughout the rest of the study no irritative effects were noted.
Other effects:
None specified

Any other information on results incl. tables

Eye irritation scores in albino rabbits following application of 0.73 gr. of TVCI B-5909 without a subsequent water rinse

Rabbit Number

Time

Cornea

Iris

Conjunctivae

Total Score*

Days

Opacity

Area

Erythema

Swelling

Discharge

1

(117)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

2

(18)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

3

(35)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

(136)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

5

(137)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

6

(138)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

*Total score is sum of the following three sub-totals:

(a) degree of opacity x area involved x 5

(b) iris score x 5

(c) sum of scores for erythema, swelling and discharge x 2

Total possible score = 110

 

Eye irritation scores in albino rabbits following application of 0.73 gr. of TVCI B-5909 with subsequent water rinse after 30 seconds for 60 seconds in 200 ml tap water

Rabbit Number

Time

Cornea

Iris

Conjunctivae

Total Score*

Opacity

Area

Erythema

Swelling

Discharge

7

(139)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

8

(125)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

9

(123)

1

2

3

4

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

*Total Score is the sum if the following three sub-totals:

(a) degree of opacity x area involved x 5

(b) iris score x 5

(c) sum of scores for erythema, swelling and discharge x 2

Total possible score = 110

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mild conjunctival erythema was noted in five rabbits with non-rinsed eyes and in one rabbit with a rinsed eye at the 24-hour reading.
Executive summary:

The purpose of this study was to evaluate the eye irritation potential of the test material in accordance with Section 162.81 of the Regulations for the Enforcement of the Federal .Insecticide, Fungicide, and Rodenticide Act, (Federal Register, Wednesday, June 25, 1975).

 

Nine New Zealand White rabbits were used in the study.

0.73 gram of the test material (weight of volume occupying 0.1 ml) was applied to the right eye of each of the 9 rabbits. The left eyes were untreated and served as controls. The treated eyes of 6 rabbits were left unrinsed, the treated eyes of 3 rabbits were rinsed after 30 seconds for 60 seconds with 200 ml of lukewarm tap water. Examinations for gross signs of eye irritation were made at 24 hrs., 48 hrs., and 72 hrs., 4 days and 7 days following application. Scoring of irritative effects was according to the method of Draize.

 

Mild conjunctival erythema was noted in five rabbits with non-rinsed eyes and in one rabbit with a rinsed eye at the 24-hour reading.

Based on these results TVCI B-5909 is classified in Toxicity Category III for eye effects as these categories are described in Section 162.10 of the above-cited Regulations (Federal Register, Thursday, July 3, 1975). This corresponds to "not irritating" under The CLP Regulation. European Regulation (EC) No 1272/2008.