Registration Dossier

Toxicological information

Eye irritation

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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:
2009
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

Constituent 1
Chemical structure
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

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.