Registration Dossier
Registration Dossier
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EC number: 259-587-9 | CAS number: 55310-46-8
Eye irritation
Administrative data
- Endpoint:
- eye 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- other: GLP-compliance OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England.
- Age at study initiation: 4 months old
- Weight at study initiation: 3.80 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 49-53% R.H.
- Air changes: 15 complete air changes per hour without re-circulation
- Photoperiod: 12 hrs dark / 12 hrs artificial light
IN-LIFE DATES: To: 12 May 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Observation period (in vivo):
- Animal observed for several minutes immediately following distillation, twice during the first hour after dosing and at regular interval throughout the day and daily.
Occular reaction assessed 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment. - Number of animals or in vitro replicates:
- 1 male
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance. An ulceration of the cornea observed on Day 21 was unlikely to have reflected an effect of Perkacit SBEC
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The results are applicable for 16.9% aqueous solution of the substance.
- Irritant / corrosive response data:
- A diffuse crimson-red appearance to the conjunctiva, very slight chemosis and a substantial discharge were evident throughout the first 72 hours following instillation. Slight opacity, covering up to the entire corneal surface, and iritis were observed at this time.
At the end of the first week of observation, injection of the conjunctival blood vessels and slight corneal opacity persisted; the opacity resolved by the fourteenth day after treatment, but the conjunctival change persisted to termination. - Other effects:
- Instillation of the test material caused a moderate initial pain response.
Applicant's summary and conclusion
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