Disodium octaborate

Eye irritation

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

Test material information

Constituent 1

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 bis[(oxoboranyl)oxy]bicyclo[5.5.1]hexaboroxane-3,5-bis(olate)

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

Results

Results 1

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.

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 72h

Results 14

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

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 17

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

Results 18

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

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: 72h

Remarks:

erythema score 2 after 24h

Results 20

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

Results 21

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 22

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 23

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 24

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 25

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 26

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	Cornea^a		Iris	Conjunctiva^a			Total score^bc
		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.