Sodium metaborate, anhydrous

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-03-1998 to 24-03-1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium metaborate dihydrate

Cas Number:

16800-11-6

Molecular formula:

NaBO2*2H2O

IUPAC Name:

Sodium metaborate dihydrate

Details on test material:

- Name of test material: Sodium metaborate mol 4.
- Physical state: White powder
- Analytical purity: > 99 %
- Storage condition of test material: Room teperature in the dark in the original container.
- Other: Unique dispensary No. 0603/95-1341

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Uk, Ltd.
- Age at study initiation: 14 - 19 weeks old
- Weight at study initiation: 2.8 - 3.84 kg
- Housing: In floor pens accommodating one animal throughout the acclimatisation and experimental phases.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: A period of between 5 and 7 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22 °C
- Humidity (%): Humidity was not actively controlled, but was expected to remain within the range of 40 to 80 % RH.
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg. Skin was moistened with water prior to application.

Duration of treatment / exposure:

The sentinal was dosed for 3 min, 1 h and 4 h.
Two further rabbits were subjected to single 4 h applications.

Observation period:

Three days

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 30 x 20 mm
- Type of wrap if used: The test sites were covered iwth a dense gauze patch (30 x 20 mm) which was in turn covered by a larger gauze patch (40 x 40 mm) and an open-weave, elasticated adhesive bandage which was wrapped firmly around the torso to secure the applied dose and patch to the correct position.

REMOVAL OF TEST SUBSTANCE
- Washing: On removal of the patches the treated skin was lightly brushed clean of any solid residue and swabbed with moist cotton wool.
- Time after start of exposure: The sentinal was dosed for 3 min, 1 h and 4 h. Two further rabbits were subjected to single 4 h applications.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

8

Reversibility:

other: Not applicable

Irritant / corrosive response data:

There were no irritation reactions or other dermal changes following single, semi-occluded topical applications of the test article to skin for 4 h.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

A single semi-occluded application of sodium metaborate 4 mol to intact rabbit skin for 4 h did not elicit any irritation reacions or other dermal changes.