Registration Dossier
Registration Dossier
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EC number: 224-235-5 | CAS number: 4259-15-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)
- EC Number:
- 224-235-5
- EC Name:
- Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)
- Cas Number:
- 4259-15-8
- Molecular formula:
- Too complex
- IUPAC Name:
- 1-Hexanol, 2-ethyl-, O,O-diester with phosphorodithioic acid, zinc salt
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.38 to 2.64 kg
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Number of animals or in vitro replicates:
- 9 (6 rinsed, 3 unrinsed)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): for 3 animals rinsed for one minute 200 ml of lukewarm tapwater
- Time after start of exposure: 30 seconds
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hour
- Score:
- 1.17
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hour
- Score:
- 0.6
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2.17
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2.67
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 1.55
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 1.44
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Rinsed
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the study conducted, Phosphorodithioic acid, O,O-bis(2-ethylhexyl) ester, zinc salt causes persistent eye irritation through 21 days. Rinsing the test material out of the eyes 30 seconds after the exposure resulted in eye irrtation that was reversible within 21 days.
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