Registration Dossier
Registration Dossier
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EC number: 218-679-9 | CAS number: 2215-35-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; restriction due to study being terminated prior to 21 days or until all effects had resolved.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16CFR 1500.42- Federal Hazardous Substances Act Regulations
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
- EC Number:
- 218-679-9
- EC Name:
- Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
- Cas Number:
- 2215-35-2
- Molecular formula:
- Too complex
- IUPAC Name:
- zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animal, Inc, Boyertown, PA
- Housing: Stainless Steel caging with elevated wire mesh flooring, 1 rabbit/ cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.9.
- Humidity (%):40 - 45%
Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 24 October 1983 – 31 October 1983
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 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 1, 2, 3, 4, 7days following instillation of test material into the eyes.
- Number of animals or in vitro replicates:
- 6 rabbits
- 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:
- other: 24, 48 and 72 hours
- Score:
- 0.49
- Max. score:
- 4
- Reversibility:
- other: reversible by day 7
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- other: reversible by day 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: not reversible in 2/6 animals by Day 7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: not reversible in 5/6 animals by day 7
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the test material causes irreversible effects on the eye
- Executive summary:
In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the New Zealand White rabbits (6 animals). The test substance produced ocular irritation up to 7 days.
Due to the potential irreversible effects the test substance is classified as Category 1 in accordance with the classification system of GHS.
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