Registration Dossier
Registration Dossier
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EC number: 230-257-6 | CAS number: 6990-43-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- This study was mandatory at the time of registration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; restriction due to testing not performed under GLP but data are of sufficient quality
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42-Hazardous Substance and Articles, Administration and Enforcement Regulations, Federal Register, Vol 38, No. 187, P 27019, 27 September 1973.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts
- EC Number:
- 283-392-8
- EC Name:
- Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts
- Cas Number:
- 84605-29-8
- IUPAC Name:
- zinc bis[O-(1,3-dimethylbutyl) O-isopropyl dithiophosphate]
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 Animals, Inc. Boyertown PA
- Housing: Stainless steel with elevated wire mesh flooring 1 rabbit/cage.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6–23.9
- Humidity (%):40-45%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
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
- Concentration (if solution): undiluted. - Duration of treatment / exposure:
- Test material was instilled into the conjunctival sac of 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 reactions at 1, 2, 3, 4, 7, 14 and 21 days 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: 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 72 hours
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 4/6 animals at 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.17
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects were not clear in 2/6 animals at 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.05
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 5/6 animals at 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 3.1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Effects did not clear in 6/6 animals at 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material caused ocular irritation that persisted through Day 21.
CLP: Eye irrit 1, H318
DSD: Xi, R41 - 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 21 days.
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