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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA ( 40 CFR 158, 162 ) and Toxic Substances Control Act (40 CFR 798).
Deviations:
not specified
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

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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
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
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
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
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
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
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.