Registration Dossier
Registration Dossier
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EC number: 939-460-0 | CAS number: 1471311-26-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 April 1982 - 23 April 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study with adequate description of husbandry, species, methods and results, but limited details.
- Justification for type of information:
- This study was conducted prior to the introduction of in vitro techniques.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US 16 CFR 1500.42 Federal Hazardous Substances Act
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
- EC Number:
- 939-460-0
- Cas Number:
- 1471311-26-8
- Molecular formula:
- Too complex
- IUPAC Name:
- Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Temperature: 70 degrees F +/- 2 degrees F; Relative hunmidity: 45% +/- 5%; Light: 12 hour light/dark cycle; Diet: Wayne 15% Rabbit Ration and tap water provided ad libitum; Caging: Stainless steel, elevated wire mesh flooring, 1 rabbit/cage; Bedding: Techboard
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 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):
- 1, 2, 3, 4, and 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- at the last (7 day) observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- at the last (7 day) observation
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:
- In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is required for eye irritation.
- Executive summary:
The eye irritation potential of the test substance was evaluated in rabbits. A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method. The calculated mean scores from the 24, 48, and 72 hour observations for corneal opacity, iritis, conjunctival redness, and conjuntival chemosis were 0.6, 0.0, 1.2, and 1.8, respectively. The effects were not reversible by the last observation at 7 days. In accordance with EU CLP Regulation No. 1272/2008 classification as an irreversible eye irritant is required.
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