Registration Dossier
Registration Dossier
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EC number: 813-543-0 | CAS number: 73984-93-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep/Oct 1981
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
- EC Number:
- 813-543-0
- Cas Number:
- 73984-93-7
- Molecular formula:
- C14H26N2S4
- IUPAC Name:
- 1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratories, Denver, PA
- Weight at study initiation: 2.1 to 2.4 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Rabbit Chow Complete Blend (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: approx. 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
1981-09-21 - 1981-10-5
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal had one treated eye (right eye) and one untreated eye (left eye) which served as the control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Instilled into the right eye on day 1 and allowed to remain throughout the duration of the observation period (i.e. no rinsing).
- Observation period (in vivo):
- 14 days, with ocular examinations on day 1, 2, 3, 4, 7 and 14 following test material administration.
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: fluorescein and ultraviolet light
Results and discussion
In vivo
Resultsopen allclose all
- 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:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Ocular irritation was not observed in any treated rabbits during the study.
- Other effects:
- During the course of the study, none of the animals exhibited a positive reaction.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test report describes a valid guideline study without information about GLP compliance. The test substance was not irritating to the rabbit eye under the conditions of the study.
- Executive summary:
An eye irritation study was conducted using a similar procedure to that described in the current OECD Guideline 405 (Reckers, 1981). The test material (CAS No. 73984 -93 -7) was applied at a volume of 0.1 mL to the right eye of six female rabbits (strain: New Zealand White). The test article was left in the right eye (i.e. no rinsing was performed) and the rabbits were observed during application followed by a 14 -day observation period. The left eye served as control. The treated eye was scored at day 1, 2, 3, 4, 7 and 14 following instillation. Ocular irritation was not observed in any animal during the study.
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