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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:
1998-03-25 to 2000-01-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well document study following OECD Guideline 404 performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tungsten metal
- Appearance: Grey powder
- Purity: >99%
- Stored at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: stainless steel cages with perforated floors, Building R14, Room 4
- Diet: STANRAB (P) SQC , hay ad libitum
- Water: ad libitum
- Acclimation period: 6 days
- Female

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5- 22.0
- Humidity (%): 38-62%
- Air changes (per hr): 19/hr
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
not required
Amount / concentration applied:
500 mg applied, 0.5mL distilled water added to gauze pad
Duration of treatment / exposure:
4 hours
Observation period:
72 hrs: observations made at 60min., 24, 48, and 72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25mm x 25mm (6.25 cm^2)
- Type of wrap if used: moistened gauze covered with "Elastoplast"


REMOVAL OF TEST SUBSTANCE
-After four hours site was washed with warm water, blotted dry with absorbent paper


SCORING SYSTEM: Intact skin was evaluated for erythema and edema after 1, 24, 48 and 72 hours on a scale of 0-4 for each effect.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A single semi-occlusive application of Tungsten Metal Powder to intact rabbit skin for four hours elicited no dermal irritation over a 72-hour period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occlusive application of Tungsten Metal Powder to intact rabbit skin for four hours elicited no dermal irritation over a 72-hour period.