Registration Dossier
Registration Dossier
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EC number: 272-221-2 | CAS number: 68784-12-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- and guideline compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- EC Number:
- 272-221-2
- EC Name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- Cas Number:
- 68784-12-3
- Molecular formula:
- Due to a mixture of numerous isomers a specific molecular formular cannot be provided ( UVCB-substance) .
- IUPAC Name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- Details on test material:
- - Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Yellowish clear liquid
- Analytical purity: 97.1%
- Lot/batch No.: 5500001727
- Stability under test conditions: stable
- Storage condition of test material: RT
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Age at study initiation: 9 weeks
- Weight at study initiation: 2.1 kg – 2.2 kg
- Housing:Single housing; Terulan cages, Ehret GmbH, A-3430 Tulln, 73 cm x 73 cm bottom area, 50 cm height.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30 – 70%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Approx. 1, 24, 48 and 72 h after application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: About 24 hours after application of the test item
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- The cornea and the iris were not affected in any animal at any examination term. Slight conjunctival redness (grade 1) was noted in one animal only 1 hour after application, in one animal 1 and 24 hours after application. In the third animal no conjunctival redness was observed.
Slight conjunctival chemosis was noted in all three animals only 1 hour after application. Slight discharge (grade 1) was noted in two animals only 1 h our after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, ASA is not irritating to eyes under the test conditions chosen.
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