Borate(1-), bis[ethanedioato(2-)-.kappa.O1,.kappa.O2]-, potassium (1:1), (T-4)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-11-22 to 2011-11-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant skin irritation study for lithium bis(oxalato)borate was used for read across and evaluation of skin irritation properties of potassium bis(oxalato)borate on the basis of structural similarity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24th April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

16th June 2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

244761-29-3

EC Number:

607-383-9

Cas Number:

244761-29-3

IUPAC Name:

244761-29-3

Constituent 2

Reference substance name:

Lithium bis(oxalato)borate

EC Number:

456-990-3

EC Name:

Lithium bis(oxalato)borate

IUPAC Name:

lithium bis(oxalato)borate

Test material form:

other: solid

Details on test material:

SMILES: O=C1O[B-]2(OC1=O)OC(=O)C(=O)O2.[Li+]

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S & K LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 3191-3340 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): P. Strengthened Female Hare Mixed diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 % (rel.)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin served as a control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: back and flanks
- coverage: an approximately area of 6 cm^2 of intact skin
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): body temperature water used
- Time after start of exposure: 4 hours

SCORING SYSTEM: by Draize et al. (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: very slight erythema and crust was found after 24 h

Results 2

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: very slight erythema was detected after 24 and 48 h

Results 4

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #2

Time point:

other: 24, 48. 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: very slight erythema after 24 h

Results 6

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Read across for evaluation of skin irritation properties of potassium bis(oxalato)borate from the skin irritation in vivo study results of lithium bis(oxalato)borate is justified on the basis of structural similarity of the substances. The bis(oxalato)borate salt part [B(C2O4)2] is the same in both substances and only the cationic part of salts differ (lithium or potassium). Both lithium and potassium belong to alkali-metals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the skin irritation study of lithium bis(oxalato)borate the test substance was not irritating to the intact skin of New Zealand white rabbits.
Based on structural similarity, the result can be used for read across when evaluating skin irritation properties of potassium bis(oxalato)borate. The result can be used for classification purposes. For risk assessment, also potassium bis(oxalato)borate can be regarded as not irritating to skin. See also attachment in section 13 (Analogue approach justification).

Executive summary:

The acute skin irritation study of the test item lithium bis(oxalato)borate (LiBOB) was performed in New Zealand White rabbits according to OECD guideline 404 and EU method B.4. The irritation effect of the test item was evaluated according to the Draize method. The test item was administered in pure state, in a single dose of 0.5 g, to the hairless skin of three experimental rabbits. The untreated skin of each animal served as control. After 4 hours the rest of the test item was removed with water. The animals were examined at 1, 24, 48 and 72 hours after the patch removal. One hour after the patch removal very slight and well defined erythema and very slight edema were observed. 24 hours after the patch removal very slight erythema was found in all animals and crust were recorded in one animal. 72 hours after the patch removal no primary irritation symptoms, like erythema and edema or other signs occurred on the treated skin surfaces, so the study was terminated at this time. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the patch removal) were as follows:

- erythema: 0.33, 0.66, 0.33

- edema: 0.00, 0.00, 0.00

During the study the control area was symptom-free. General state and the behavior of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period. The observed symptoms were evaluated as fully reversible alterations. From this follows lithium bis(oxalato)borate is non irritating to the intact skin of New Zealand white rabbits. (TOXICOOP, 2012).

Based on structural similarity, the result can be used for read across when evaluating skin irritation properties of potassium bis(oxalato)borate. Consequently, also potassium bis(oxalato)borate can be regarded as not irritating to skin.