Registration Dossier
Registration Dossier
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EC number: 266-582-5 | CAS number: 67124-09-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 26, 1982 - May 24, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42- Federal Hazardous Substances Act Regulations CFR16 P. 125.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(tert-dodecylthio)propan-2-ol
- EC Number:
- 266-582-5
- EC Name:
- 1-(tert-dodecylthio)propan-2-ol
- Cas Number:
- 67124-09-8
- IUPAC Name:
- 1-[(2,2-dimethyldecyl)sulfanyl]propan-2-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino rabbit; strain unknown
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Techboard, Shepherd Products Company
- Weight at study initiation: no data available
- Housing: individually housed in stainless steel cages with wire mesh flooring
- Diet (e.g. ad libitum): Wayne 15 % Rbbit Ration was provided ad libitum
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 +/- 2
- Humidity (%): 45 % +/- 5 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 0.1 mL test material was instilled into the conjunctival sac of one eye of the test animal. After instillation of the test material, the upper and lower lids were held closed for approximately 1 second to minimize loss of material. The contralateral eye was manipulated in an identical manner and served as an un-dosed control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 1h, and 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:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 0.7
- Irritation parameter:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 2 d
- Score:
- 0
- Irritation parameter:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Irritation parameter:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 4 d
- Score:
- 0
- Irritation parameter:
- other: average irritation score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1d, 2d, 3d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1d, 2d, 3d
- Score:
- 0
- Irritation parameter:
- other: conjunctivae readness
- Basis:
- mean
- Time point:
- other: 1d, 2d, 3d
- Score:
- 0.17
- Irritation parameter:
- other: conjunctivae edema
- Basis:
- mean
- Time point:
- other: 1d, 2d, 3d
- Score:
- 0.17
- Irritant / corrosive response data:
- Overall Primary Ocular Irritation Index: 0.7
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material did not cause irritating effects on the eyes, and was not a primary ocular irritant.
- Executive summary:
In a primary eye irritation study, 0.1 mL of the test substance was placed into conjuctival sac of one eye of each of the albino rabbits. The eyes were examined and graded for ocular reaction at 1h, and 1, 2, 3, 4, 7 days following instillation of test material into the eyes. The overall primary ocular irritation index was 0.7 and the test substance was unlikely to be an ocular irritant in the test animals
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