Registration Dossier
Registration Dossier
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EC number: 294-415-6 | CAS number: 91722-14-4
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: The study has been conducted according to OECD guideline No. 405 and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- Soybean oil, epoxidized, acrylate
- EC Number:
- 294-415-6
- EC Name:
- Soybean oil, epoxidized, acrylate
- Cas Number:
- 91722-14-4
- Molecular formula:
- C63H108O15
- IUPAC Name:
- Soybean oil, epoxidized, acrylate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SAT 981 170 (PHOTOMER 3005 F)
- Substance type: UVCB
- Physical state: yellowish to brownish, viscous liquid
- Lot/batch No.: 3828246463
- Expiration date of the lot/batch: 14 April 1999
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted test substance - Duration of treatment / exposure:
- The left eye of the rabbit was treated. The right eye remained untreated and served as control. 0.1 ml of the test substance was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second.
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reactions was recorded at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Three female rabbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the first 24 hour reading, fluorescin was instilled. After rinsing with 20 ml 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage.
- Time after start of exposure: 24 hours
SCORING SYSTEM: The eyes were examined at 1, 24, 48 and 72 hours after treatment for possible damage to the corena, iris and conjunctivae.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria listed in Directive 93/21/EEC of 27 April, 1993. the test substance shall not be classified as an eye irritant.
- Executive summary:
The eye irritant effect of the test substance (SAT 981 170) was investigated according to the method recommended in OECD guideline No. 405, "Acute Eye Irritation/Corrosion' and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)".
Three female albino rabbits were exposed to 0.1 ml of the test substance in the left eye. The eyes were examined and the changes were graded according to a numerical scale at 1, 24, 48 and 72 hours after dosing. Very slight signs of eye irritation were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for eye irritation. Effects were fully reversible 72 hours after exposure.
In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as an eye irritant.
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