Registration Dossier
Registration Dossier
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EC number: 236-743-4 | CAS number: 13472-45-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to the OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium wolframate
- EC Number:
- 236-743-4
- EC Name:
- Disodium wolframate
- Cas Number:
- 13472-45-2
- Molecular formula:
- Na2WO4
- IUPAC Name:
- disodium dioxotungstenbis(olate)
- Details on test material:
- - Name of test material (as cited in study report): Sodium Tungstate Dihydrate
- Substance type: Active
- Physical state: White Powder
- Analytical purity: 99.9%
- Storage condition of test material: Room Temperature
Constituent 1
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 12 weeks
- Weight at study initiation: 2.2 to 2.8 g
- Housing: Individually in stainless steel cages with perforated floors.
- Diet: Standard laboratory diet STANRAB (P) SQC Rabbit Diet was provided ad libitum.
- Water: Drinking water was provided ad libitum.
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22.5
- Humidity (%): 36 to 58%
- Air changes (per hr): 19/hr
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Distilled water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- ~ 4 hours.
- Observation period:
- ~60 minutes after removal of the dressing,
Days 24, 48, and 72 hours. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 100 mm x 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water.
- Time after start of exposure: Immediately after end of exposure period.
SCORING SYSTEM: Animals were scored based on the scoring system presented at each observation point.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed throughout the observation period.
- Other effects:
- No animals displayed any signs of ill health or toxicity throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
No dermal response to treatment was observed in any animal throughout the study.
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