Registration Dossier
Registration Dossier
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EC number: 821-762-8 | CAS number: 4563-56-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- no
- 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:
- - Source: LSR Industries Inc.
- Housing: singly in wire mesh suspension cages
- Diet: ad libitum
- Water: ad libitum.
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 01 June 1992 – 18 June 1992
Test system
- Vehicle:
- other: mineral oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 24, 48, and 72 hours following instillation of test material into the eyes
- Number of animals or in vitro replicates:
- 12 rabbits (three males and three females per group)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: not applicable
SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 2/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 4/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in 4/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 6/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 1/6 animals
- Remarks on result:
- other: 50% in mineral oil
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
- Executive summary:
In a primary eye irritation study, 0.1 mL of undiluted test substance or 50% in mineral oil was placed into one eye of each of the New Zealand White rabbits. The test substance produced serious eye damage up to 72 hours when tested as supplied and was not an ocular irritant when tested as a 50% formulation in mineral oil.
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