Registration Dossier
Registration Dossier
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EC number: 424-970-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 April - 11 April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA, 40 CFR, part 798, subpart E guideline section 798.000 (1989)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 424-970-3
- EC Name:
- -
- Cas Number:
- 166255-23-8
- Molecular formula:
- C16-H14-O3.C6-H16-O3-Si
- IUPAC Name:
- Triethoxysilylpropyl Dibenzoyl Resorcinol
- Test material form:
- solid
- Details on test material:
- Color: Light beige
Constituent 1
- Specific details on test material used for the study:
- Stability: stable
Solubility: toluene, methylene chloride
Insoluble: water
Storage conditions: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Eastern Rabbit Breeding Laboratory, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in suspended stainless steel cages with hardwood chips as bedding material
- Diet: commercial rabbit ration (Agway Prolab, Waverly, NY), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: minimum of 3 days
ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 April To: 11 April 1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg; The test substance was grounded to a fine powder. The weight of 0.1 mL volume of the powder was greater than 100 mg.
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- Eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Fluorescein staining was used during each examination, excluding the 1 hour exam. Reading of reactions was facilitated by the use of a hand held slit-lamp.
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Both eyes of each rabbit were examined for macroscopic findings with a fluorescein dye procedure before the experimental start.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3, 4, 5 and 6
- 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:
- animal: 1, 2, 3, 4, 5 and 6
- 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
- Remarks:
- Redness
- Basis:
- animal: 1, 2, 4, 5 and 6
- 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:
- animal: 1, 2, 3, 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No positive signs of irritation were noted in the treated or control eyes at any of the observation points. No fluorescein staining was observed in the treated or control eyes at any observation point. No fluorescein staining was performed at the 1 hr observation point.
- Other effects:
- All animals exhibited an increase in body weight during the course of the study.
No overt signs of toxicity were evident during the course of the study, in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vivo eye irritation study with 6 rabbits it is concluded that SDBR has no adverse effects on the eye.
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