Disodium octaborate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FIFRA ( 40 CFR 158, 162 ) and Toxic Substances Control Act (40 CFR 798).

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Acceptable protocol at the time of testing.

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 octoboate tetrahydrate
- Physical state: White powder
- Analytical purity: > 98 %
- Lot/batch No.: 8G1D
- Stability under test conditions: Stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Clerco Research Farm

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Hair was clipped from the dorsal area of each rabbit and one area on each rabbit treated with substance.

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 /sex/group

Details on study design:

TEST SITE
- Type of wrap if used: Occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moistened towel
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 8

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 15

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritancy was observed.

Other effects:

No data

Any other information on results incl. tables

Primary skin irritation in rabbits following a 4-h dermal application of disodium octaborate tetrahydrate:

Skin condition	Observation time (h)	Score for each rabbit						Total score	Average score
		1	2	3	4	5	6
Erythema formation
Intact	½ - 1	1	1	1	2	1	1	7.00	1.17
	24	0	0	1	1	0	1	3.00	0.5
	48	0H^*	1H	0H	0H	0H	0H	1.00	0.17
	72	0H	0H	0H	0H	0H	0H	0.0	0.0
Edema formation
Intact	½ - 1	0	0	0	1	0	1	2.00	0.33
	24	0	0	0	0	0	0	0.00	0.0
	48	0	0	0	0	0	0	0.00	0.0
	72	0	0	0	0	0	0	0.00	0.0
Primary irritation index (PII)									0.5

* Hair on site

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS Criteria not met

Conclusions:

In the acute dermal irritation study no irritancy was observed. The protocol meets the requirements of OECD 404.

Executive summary:

The test item disodium octaborate tetrahydrate was assessed for acute skin irritation/corrosion in rabbits in a GLP study similar to OECD Guideline 404. The test item did not cause skin irritation when applied in physiological saline to the intact or abraded skin of 3 animals at a dose of 0.5 g under socclusive dressing for 72h.