Registration Dossier
Registration Dossier
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EC number: 820-225-5 | CAS number: 101747-77-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study:1
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)
- Deviations:
- not specified
- 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:
- C16H35O2PS2.1/2Zn
- 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
- 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
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - 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 h
- Score:
- 1.17
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.6
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.17
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.67
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.55
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.44
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: classified in Cat.1 (irreversible effects on the eye) according to the CLP Regulation (EC) No. 1272/2008
- 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.
- Executive summary:
Eye irritation was tested according to OECD Guideline 405. In this study Phosphorodithioic acid, O,O-bis(2-ethylhexyl) ester, zinc salt caused 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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