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EC number: 480-070-0 | CAS number: 85-27-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2007-05-08 to 2007-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study reliable without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : an initial test was not performed. Three animals were were tested at the same time; justification for choice of vehicle was not stated
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : an initial test was not performed. Three animals were were tested at the same time; justification for choice of vehicle was not stated
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 480-070-0
- EC Name:
- -
- Cas Number:
- 85-27-8
- Molecular formula:
- C14H14O2
- IUPAC Name:
- 4-(1-phenylethyl)benzene-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): SymWhite 377
- Chemical name: 4-(1-phenylethyl)-1,3-Benzenediol
- Physical state: White to beige powder
- Storage condition of test material: room temperature, airtight
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS rabbit, NZW (Yac:NZW(KBL)
- Origin: Yonam College of Agriculture, San 3-1, Suhyang-ri, Seonghwan-eup, Cheonan-si, Chungcheongnam-do, Korea
- Supplier: ORIENTBIO INC., 143-1, Sangdaewon-dong, Jungwon-gu, Sungnam-si, Gyeonggi-do, Korea
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.48 ~ 2.78 kg
- Housing: stainless cages, 380Wx490Dx350H (mm); individually housed
- Diet (ad libitum): Purina experimental diet for rabbit 5302 (Lot No.: KSN:04:05:LNS)(supplier: Agribrands Purina Korea Inc., 627, Jangdang-dong, Pyeongtaek-si, Gyeonggi-do, Korea
- Water (ad libitum): filtered and purified drinking water
- Acclimation period: in quarantine and acclimation for 8 days, the monitoring of clinical signs was performed once a day. At the end of quarantine and acclimation healthy rabbits with normal eyes were selected through eye detection with an ophthalmoscope (Part Number: 1127-P-1005, Keeler Instruments Inc.).
ENVIRONMENTAL CONDITIONS
- Temperature: 20.5 ~ 22.0 °C
- Relative humidity: 42.0 ~ 68.4 %
- Air changes: 10 ~ 15 air changes per hour (all fresh air method)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: olive oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the test substance (5 %) of 0.1 mL was administered to the conjunctival sac of the right eye after gently pulling over the lower eyelid away from the eyeball using a disposable syringe. The lids were then gently held together for about one second in order to prevent the loss of the test substnace. The other eye, which remains untreated, serves as a control.
- Concentration: test substance was weighed using the balance (CP323S, Sartorius, Germany); it was dissolved in olive oil to produce 5 % (w/v) concentration.
VEHICLE
- Lot no.: 045K6094
- Storage conditions: room temperature
- Supplier: Sigma Aldrich Co., Ltd., U.S.A. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1, 24, 48, 72 and 96 hours after the administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: according to the Draize scale
OBSERVATIONS
- Clinical signs and body weights: the animals were regularly observed for clinical signs once a day during the observation period. Individual body weights were measured on the first day of the administration (Day 0) and the last day during the observation period with the balance (HW-60KGL, AND Korea).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- At 1 hour reading after the administration, the redness in conjunctiva, chemosis in conjunctiva and discharge with score 1 were observed in all animals.
At 24 hour reading, the redness and chemosis in conjunctiva with score 1 were observed in two animals. In addition, the redness in conjunctiva and discharge with score 1 and the chemosis in conjunctiva with score 2 were observed in one animal.
At 48 hour reading, the discharge with score 1 was observed in one animal.
Eye irritation was not observed in all animals at 72 and 96 hour reading after the administration.
Adverse effects on the cornea and iris were not observed in all three animals. - Other effects:
- Clinical signs and mortality: throughout the study, all animals appeared normal and there were no abnormalities in clinical signs and death attributed to treatment of the test substance during the observation period.
-Changes of body weights: the body weights of all animals were typically increased during the observation period and mean body weight gain was 0.09 kg.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A 5 % solution of SymWhite 377 is not irritating to the eyes.
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