Registration Dossier
Registration Dossier
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EC number: 231-551-7 | CAS number: 7631-95-0
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:
- 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:
- 1 990
- 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
- Reference substance name:
- disodium molybdate
- IUPAC Name:
- disodium molybdate
- Reference substance name:
- 7631-95-0
- Cas Number:
- 7631-95-0
- IUPAC Name:
- 7631-95-0
- Reference substance name:
- Disodium molybdate
- EC Number:
- 231-551-7
- EC Name:
- Disodium molybdate
- Cas Number:
- 7631-95-0
- Molecular formula:
- Na2MoO4.2H2O
- IUPAC Name:
- disodium tetraoxomolybdate dihydrate
- 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.
Constituent 1
Constituent 2
Constituent 3
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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