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Diss Factsheets

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:
2001-02-27 to 2001-03-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992-07-17
Deviations:
yes
Remarks:
deviation from the guideline occurred, with no effect on the results of the study: individual body weights of the animals were not given
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Boron
EC Number:
231-151-2
EC Name:
Boron
Cas Number:
7440-42-8
Molecular formula:
B
IUPAC Name:
borane
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Boron amorphous
- Physical state: powder
- Storage condition of test material: room temperature
- Average particle size: 0.9 µm
- Specific surface area: 11.1 m^2/g

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: at least 12 weeks of age
- Weight at study initiation: 2.6 to 2.8 kg
- Housing: animals were housed individually in stainless steel cages with perforated floors.
- Diet (ad libitum): a standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet); the animals were fed hay on arrival and subsequently three times a week.
- Water (ad libitum): drinking water
- Acclimation period: five days prior to start of study

During the acclimatisation and study period the animals were given small (approximately 5 cm x 2 cm x 2 cm) soft white untreated wood blocks for environmental enrichment.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Relative humidity: 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g of the test substance moistened with distilled water.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
Duration of treatment / exposure:
4 hours
Observation period:
approximately 60 minutes after removal of the dressings and approximately 24, 48 and 72 hours after exposure
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumber region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
The test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad, which had been moistened with distilled water, to one intact skin site on each animal.
- Type of wrap: each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing and gauze pad were removed and the treatment site was washed with warm water (37°C) to remove any residual test substance. The treated area was blotted dry with absorbant paper.
- Time after start of exposure: at the end of the exposure period

SCORING SYSTEM: according to the Draize scoring system
Any other reaction not covered by this scoring system was described.

OBSERVATIONS:
- Clinical sings: all animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Brown residual test substance staining (assessment of erythema not impaired) was observed at the approximately 60 minutes and 24 hour observations.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal irritation was observed following a single semi-occlusive application of boron amorphous to intact rabbit skin for four hours. Brown residual test substance staining (which did not impair assessment of erythema) was noted for all animals during the study.
Other effects:
- Clinical signs: there were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
A single semi-occlusive application of boron amorphous to intact rabbit skin for four hours elicited no dermal irritation.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.