Registration Dossier

Diss Factsheets

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 1998-02-28 28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that was conducted in accordance to GLP and OECD guideline 404 with no deviation to the protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium wolframate
EC Number:
234-364-9
EC Name:
Ammonium wolframate
Cas Number:
11120-25-5
Molecular formula:
(NH4)10H2W12O42*4H2O
IUPAC Name:
Ammonium (para)tungstate
Constituent 2
Reference substance name:
Ammonium paratungstate
IUPAC Name:
Ammonium paratungstate
Details on test material:
- Name of test material (as cited in study report): Ammonium Paratungstate (CAS# as cited in study: 12028-06-7)
- Physical state: White powder
- Analytical purity: >99.9%
- Storage condition of test material: Room temperature

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: 10 to 11 weeks
- Weight at study initiation: 2.2 to 2.6 kg
- Housing: Individually in metal cages with perforated floors
- Diet (eg ad libitum): STANRAB (P) SQC Rabbit Diet- ad libitum
- Water (eg ad libitum): ad libitum
- Acclimation period: Acclimated, but period not stated.

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

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance was applied under a 25 mm x 25 mm gauze pad.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
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-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
- Type of wrap if used: Semi-occlusive dressing and gauze pad.
- 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. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water (35 °C) and area blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Local dermal irritation was scored according to Draize.

CLINICAL SIGNS:
All animals were observed daily for signs of ill health or toxicity.

DERMAL RESPONSES:
Examination of the treated skin was made on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3, and 4 (equivalent to 24, 48 and 72 hours after exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean score for all 3 male rabbit
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
No erythema
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean score for all 3 male rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
No edema
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the study.
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:
GHS criteria not met
Conclusions:
A single semi-occlusive application of ammonium paratungstate to intact rabbit skin for four hours elicited no dermal irritation.

Categories Display