Registration Dossier
Registration Dossier
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EC number: 259-587-9 | CAS number: 55310-46-8
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:
- other: GLP-compliance OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Test substance characterisation and stability data not developed in accordance with the standard
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium dibenzyldithiocarbamate
- EC Number:
- 259-587-9
- EC Name:
- Sodium dibenzyldithiocarbamate
- Cas Number:
- 55310-46-8
- Molecular formula:
- C15H15NS2.Na
- IUPAC Name:
- sodium (dibenzylcarbamothioyl)sulfanide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: 3 to 3,5 months old
- Weight at study initiation: 2.67 to 2.90 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21 °C
- Humidity (%): 43-53% R.H.
- Air changes: 15 complete air changes per hour without re-circulation
- Photoperiod: 12 hrs dark / 12 hrs artificial light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours and 6 days after bandage removal.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorsum
- Test sites: 6x6 cm
REMOVAL OF TEST SUBSTANCE
- Washing: washed with warm water and dried with paper towels
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.9
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.47
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance.
- Irritant / corrosive response data:
- Very slight or well defined erythema and very slight oedema were observed at the test sites of two rabbits during the fisrt 24 or 48 hours after bandange removal. Very slight erythema alone was evident at the 72 hours examination.
- Other effects:
- None
Applicant's summary and conclusion
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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