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Registration Dossier
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EC number: 608-605-7 | CAS number: 313482-99-4
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-07 to 2003-01-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester
- EC Number:
- 608-605-7
- Cas Number:
- 313482-99-4
- Molecular formula:
- C22H26O5Si
- IUPAC Name:
- 9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester
- Test material form:
- solid
- Details on test material:
- - State of aggregation: yellow mass (frozen melt)
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test substance was ground to a powder using a mortar and pestle prior to weighing.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 11 - 13 weeks old
- Weight at study initiation: 2573 - 2680 g
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g/day; pressed hay (BMI, Helmond, the Netherlands) twice a week
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative Humidity: 30 - 70 %
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 41.6 mg (41.2 - 42.0 mg) of the test substance (a volume of approx. 0.1 mL) in the conjunctival sac of one of the eyes after gently pulling the
lower lid away from the eyeball.
- Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- approx. 1, 24, 48 and 72 hours after instillation of the test substance
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
Draize scale
TOOL USED TO ASSESS SCORE:
lmmediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial
damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
OBSERVATIONS:
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: day of treatment (prior to application) and at termination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: see "Remarks"
- Remarks:
- Discharge and remnants of the test item were observed at the 1 hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: see "Remarks"
- Remarks:
- Discharge was observed at the 1 and 24 hour observations. Remnants of the test substance in the eye at the 1 hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: see 2Remarks"
- Remarks:
- Discharge and remnants of the test item were observed at the 1 hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of approximately 42 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as
redness, chemosis and discharge. The irritation had completely resolved within 48 hours in one animal and in 72 hours in the other animals.
No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
No staining of (peri) ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of all animals on day 1. - Other effects:
- - Lesions and clinical observations: no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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