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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:
1990-07-10 to 1990-07-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
conducted and documented in accordance with GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12 May 1981
Deviations:
yes
Remarks:
The test substance only was applied to 2.5 cm square of skin instead to approximately 6 cm square of skin
GLP compliance:
yes
Remarks:
The study report states that the study was conducted in compliance with Good Laboratory Practice Standards, e.g. by the United Kingdom Compliance Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health, 1989.

Test material

Constituent 1
Reference substance name:
disodium molybdate
IUPAC Name:
disodium molybdate
Constituent 2
Reference substance name:
7631-95-0
Cas Number:
7631-95-0
IUPAC Name:
7631-95-0
Constituent 3
Chemical structure
Reference substance name:
Disodium molybdate
EC Number:
231-551-7
EC Name:
Disodium molybdate
Cas Number:
7631-95-0
Molecular formula:
Na2MoO4
IUPAC Name:
231-551-7
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sodium molybdate
- Physical state: white crystalline powder
- Analytical purity: 98.8 % (calculated based on Molybdenum ontent of 46.03%)
- Impurities (identity and concentrations): no relevant impurities were stated (> 1.0 %)
- Purity test date: 1990-06-06
- Storage condition of test material: at ambient temperature

No further significant information on test material stated.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 9 to 11 weeks
- Weight at study initiation: 2.2 to 2.6 kg
- Housing: individually housed in metal cages with perforated floors.
- Diet (ad libitum): SDS Standard rabbit diet
- Water (ad libitum): tap water
- Acclimation period: time period not stated


ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19°C
- Humidity: 30 -70 %
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

No further significant information was stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g amount of Sodium molybdate

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml distilled water

No further significant information stated.
Duration of treatment / exposure:
4 hour period
Observation period:
Examination of treated skin was made on day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. All animals were observed daily for signs of ill health of toxic signs.
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region (hair removed such that an area of skin of approximately 10 cm square was exposed).
- Type of wrap if used: A 2.5 cm square gauze pad was used. Each treatment site was occluded with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed using water to remove any residual test substance.
- Time after start of exposure: At the end of the exposure period. (Exposure period: 4 h)

SCORING SYSTEM:
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and Eschar Formation:
no erythema = 0
very slight erythema (barely perceptible) = 1
well-defined erythema = 2
moderate to severe erythema = 3
serve erythema (beet redness) to slight eschar formation (injuries in depth) = 4

Oedema Formation:
no oedema = 0
very slight oedema (barely perceptible) = 1
slight oedema (edges of area well-defined by definite raising) = 2
moderate oedema (raised approximately 1 millimetre) = 3
serve oedema (raised more than 1 millimetre and extending beyond the area of exposure) = 4

No further significant information stated.

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
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
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
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no response to treatment in any animal throughout the observation period.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
A single semi-occlusive application of sodium molybdate to intact rabbit skin for four hours elicited no dermal irritation.
Sodium molybdate does not require classification as a skin irritant according to directive 67/548/EEC or regulation 1272/2008/EC.