Dipotassium tetraoxomolybdate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study

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:

other: Guideline study, 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

Test material information

Constituent 1

Reference substance name:

Diammonium dimolybdate

EC Number:

248-517-2

EC Name:

Diammonium dimolybdate

Cas Number:

27546-07-2

IUPAC Name:

Diammonium dimolybdate

Details on test material:

- Name of test material : ammonium dimolybdate
- Physical state: white crystalline powder
- Analytical purity: > 99.9 % (calculated based on Molybdenum content of 56.43%)
- Impurities (identity and concentrations): no relevant impurities (> 1.0 %)
- Purity test date: 1990-06-06
- Stability under test conditions: not determined
- Storage condition of test material: at ambient temperature

No further significant information on test material was 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 12 weeks
- Weight at study initiation: weight range 2.2 to 2.7 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: free access to SDS Standard Rabbit Diet
- Water: free access to tap water
- Acclimation period: The rabbits were acclimated to the laboratory environment, but the acclimatisation period was not stated.


ENVIRONMENTAL CONDITIONS
- Temperature: maintained at approximately 19 °C
- relative humidity: maintained at 30 - 70 %
- Air exchanges: maintained at approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs

No further significant information on test animals were given.

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 Ammonium molybdate

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

No further significant information was stated.

Duration of treatment / exposure:

four 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 or toxic signs.

Number of animals:

6 female 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-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
- 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 hours)

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
Severe 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
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) = 4

No further significant information on study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4

Score:

0

Max. score:

0

Remarks on result:

other: No response to treatment in any animal throughout the observation period.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4

Score:

0

Max. score:

0

Remarks on result:

other: No response to treatment in any animal throughout the observation period.

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

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A single semi-occlusive application of Ammonium dimolybdate to intact rabbit skin for four hours elicited no dermal irritation.
Ammonium dimolybdate does not require classification as a skin irritant according to directive 67/548/EEC or regulation 1272/2008/EC.