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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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR)
Deviations:
no
Principles of method if other than guideline:
The primary ocular irritancy of the test substance was evaluated in compliance with the conditions specified in the regulation for the enforcement of FIFRA (40 CFR).The test material was applied at a dose of 0.053 g to one eye of 6 rabbits. The eyes were rinsed after 24 h and fluorescein staining utilised for scoring.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium octaborate
EC Number:
234-541-0
EC Name:
Disodium octaborate
Cas Number:
12008-41-2
Molecular formula:
Na2B8O13
IUPAC Name:
disodium octaborate
Details on test material:
- Name of test material: Disodium octaborate tetrahydrate
- Physical state: Fine white powder
- Lot/batch No.: 9B13G22
- Storage condition of test material: Room temperature in a small nalgene bottle

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm.
- Housing: Singly in suspension cages with wire mesh floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 1 day.


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/light

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
0.053 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not specified
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Non Irritant. No animals met irritation criteria based on average scores for cornea and/or iris <1 and/or conjunctiva (redness and chemosis) < 2; calculated as the mean scores following grading at 24, 48 and 72 h after installation of the test substance.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48h
Remarks:
erythema score 1 observed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48h
Remarks:
erythema score 1 observed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 48h
Remarks:
erythema score 2 observed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72h
Remarks:
erythema score 2 after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72h
Remarks:
erythema score 1 observed after 24h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48h
Remarks:
swelling score 1 observed after 24h
Irritant / corrosive response data:
The test material produced iritis and conjunctival irritation persisting for less than 72 h when applied without rinsing. Irritation scores in individual animals ranged from 2 to 19. No evidence of corrosion was noted.
Other effects:
No data

Any other information on results incl. tables

Primary eye irritation in rabbits following an ocular application of disodium octoborate tetrahydrate:

Animal no.

Time

Corneaa

Iris

Conjunctivaa

Total scorebc

A

B

C

D

E

I-NP

1 h

0

0

1

2

2

0

13

24 h

0/0

0/0

0

1

0

0

2/2

48 h

0/0

0/0

0

0

0

0

0/0

72 h

0/0

0/0

0

0

0

0

0/0

2-P

1 h

0

0

1

2

2

1

15

24 h

0/0

0/0

0

0

0

0

0/0

48 h

0/0

0/0

0

0

0

0

0/0

72 h

0/0

0/0

0

0

0

0

0/0

3-P

1 h

0

0

1

3

2

1

17

24 h

0/0

0/0

0

0

0

0

0/0

48 h

0/0

0/0

0

0

0

0

0/0

72 h

0/0

0/0

0

0

0

0

0/0

4-P

1 h

0

0

0

2

1

0

6

24 h

0/0

0/0

0

1

0

0

2/2

48 h

0/0

0/0

0

0

0

0

0/0

72 h

0/0

0/0

0

0

0

0

0/0

5-P

1 h

0

0

1

3

2

1

17

24 h

0/0

0/0

0

2

0

0

4/4

48 h

0/0

0/0

0

0

0

0

0/0

72 h

0/0

0/0

0

0

0

0

0/0

6-P

1 h

0

0

1

3

2

2

19

24 h

0/0

0/0

1

2

1

0

11/11

48 h

0/0

0/0

1

1

0

0

7/7

72 h

0/0

0/0

0

0

0

0

0/0

a A = degree of opacity; B = area affected; C = erythema; D = swelling; E = discharge

b Scored accoring to Draize

c Total score is the sum of the following three sub-totals, with maximum score of 110; ( / ) = score without/with sodium fluorescein:

1. Degree of opacity x area involved x 5

2. Iris score x 5

3. (Sum of scores for erythema, swelling and discharge) x 2.

P - Photographs of all test eyes were taken at the 1 h; 24 h and 48 h readings. Animal No. 6 also have the control eye taken at the 48 h reading.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS Criteria not met
Conclusions:
The test material produced iritis and conjunctival irritation persisting for less than 72 h when applied without rinsing to the eyes of six New Zealand white rabbits. Irritation scores for individual animals ranged from 2 to 19. No evidence of corrosion was noted. However, the EU GHS criteria for classification are not met.
Executive summary:

The primary ocular irritancy of disodium octaborate tetrahydrate was evaluated in compliance with the conditions specified in the regulation for the enforcememnt of FIFRA in compliance with GLP requirements. The test was performed with 6 animals (rabbits), 0.053 g of the test item was applied to one eye, with the other eye serving as control. The test material produced iritis and conjunctival irritation persisting for less than 72 h when applied without rinsing to the eyes of six New Zealand white rabbits.  Irritation scores for individual animals ranged from 2 to 19.  No evidence of corrosion was noted. However, the EU GHS criteria for classification are not met.