Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-02-25 to 1999-09-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
ell documented, scientifically sound study that was conducted according to GLP and OECD guideline 404 with no deviations.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999
Reference Type:
publication
Title:
SIDS Initial Assessment Report for SIAM 21 for Tungsten Carbide (12070-12-1), Washington DC,18-20 October, 2005
Author:
OECD-SIDS
Year:
2005
Bibliographic source:
UNEP Publications
Report Date:
2005

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
Details on test material:
- Name of test material (as cited in study report): Tungsten carbide powder WC HC 240
- Analytical purity > 99.98%.
- Physical state: Grey powder
- Storage condition of test material: 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 to 11 weeks
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: Individually in stainless steel cages with perforated floors.
- Diet (ad libitum): STANRAB (P) SQC Rabbit Diet-ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes; time period not given.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22.5
- Humidity (%): 39-56%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 light (0700-1900 hrs)/12 dark

IN-LIFE DATES: From: 1998-02-25 To: 1998-02-28

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Approximately 0.5 g of test substance was applied under a 25 mm x 25 mm gauze pad which was moistened with 0.5 mL of distilled water, to one intact skin site on each animal.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 24 hours prior to application of test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit.
- % coverage: Exposed an area of skin approximately 100 x 100 mm.
- Type of wrap if used: Each site was covered with "Elastoplast" elastic adhesive dressing for 4 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 days, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water to remove any residual test substance. The treated area was blotted dry with absorbent paper.


SCORING SYSTEM: Dermal irritation was scored according to Draize




Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
for all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout 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:
GHS criteria not met
Conclusions:
A single semi-occlusive application of Tungsten Carbide Powder- Pure to intact rabbit skin for four hours elicited no dermal irritation.