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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 27 December 2006 and 26 February 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): ELDEW APS-307
- Chemical name: Phytosteryl/Decyltetradecyl Myristoyl Methyl Beta-Alaninate
- Substance type: Organic UVCB
- Physical state: Wax
- Analytical purity: 100 %
- Lot/batch No.: 609074
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature, light shielding

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
SUKA FLAT, 1846 Saiba, Sugito-cho, Kitakatsushika-gun, Saitama Prefecture

- Age at study initiation:
Not stated

- Weight at study initiation:
2.26 kg to 2.58 kg

- Housing:
Animals were housed individually in Metal bracket cages.

- Diet (e.g. ad libitum):
Solid feed for test animals (RC-4). Animals were on a restricted diet of 100 g of feed a day, which was fed using an
automatic feeder. Food supplied by Oriental Yeast Co., Ltd., 3-6-10 Azusawa, Itabashi-ku, Tokyo, Japan.


- Water (e.g. ad libitum):
Tap water with chlorine added. Animals had free access to water through an automatic water supplying system.Tap water supplied by Kawasaki Waterworks Bureau.

- Acclimation period:
Thirteen days


ENVIRONMENTAL CONDITIONS

- Temperature (°C):
20 to 26°C

- Humidity (%):
30 to 70%

- Air changes (per hr):
All-fresh ventilation of 10 to 15 cycles per hour

- Photoperiod (hrs dark / hrs light):
Twelve hours continuous light (07:00 to 19:00) and twelve hours darkness


Test system

Vehicle:
unchanged (no vehicle)
Remarks:
The test article was double-boiled in its original form to make it soft and then used in the experiment.
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 mL of the test article was ocularly instilled.
Application Method: Observations were conducted on both eyes of the rabbits before instillation to visually confirm that were no abnormalities. The animals were fixed in place using retention devices. The lower eyelid of the right eye was pulled away from the eyeball in a saclike state. 0.1 mL of the test article was ocularly instilled. After instillation, the upper and lower eyelids were gently held together for 2 to 3 seconds. The left eye was left untreated.

- Concentration (if solution):
Undiluted. The test article was double-boiled in its original form to make it soft and then used in the experiment.

VEHICLE

- Amount(s) applied (volume or weight with unit):
Not applicable

- Concentration (if solution):
Not applicable

- Lot/batch no. (if required):
Not applicable

- Purity:
Not reported
Duration of treatment / exposure:

72 hours
Observation period (in vivo):

Approximately 1 hour and 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
3 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. )
Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done):
Not applicable

- Time after start of exposure:
Not applicable


SCORING SYSTEM:

Observation of eye irritation:
Observations were conducted 1, 24, 48, and 72 hours after ocular instillation, and eye irritation was assessed in accordance with Grading criteria for ocular reactions below:

Grading criteria for ocular reactions

A. Cornea
Opacity: Degree of Density (readings was taken from most dense area)
0: No ulceration or opacity
1: Scattered or diffuse area of opacity (other than slight dulling of normal lustre); details of iris clearly visible
2: Easily discernible translucent area; details of iris slightly obscured
3: Nacrous area; no details of iris visible; size of pupil barely discernible
4. Opaque cornea; iris not discernible through the opacity

B. Iris
0: Normal
1: Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light( a sluggish reaction is considered to be an effect)
2: Hemorrhage, gross destruction, and/or no reaction to light (any or all of these conditions)

C. Conjunctivae
a. Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
0: Normal
1: Some blood vessels hyperemic (injected)
2: Diffuse, crimson colour; individual vessels not easily discernible
3: Diffuse beefy red
b. Chemosis Swelling (refers to lids and/or nictating membranes)
0: Normal
1: Some swelling above normal
2: Obvious swelling, with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed

As a reaction other than those described in Grading criteria for ocular reactions, secreta was also observed. Scoring was conducted based on the following grading criteria.

Secreta
0: No secreta observed
1: Somewhat large amount of secreta (more than the normal amount)
2: Large amount of secreta (secreta is evident, making the lids and nearby hairs moist)
3: Extremely large amount of secreta (secreta is evident, making the lids and much of the surrounding hairs moist)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 00101 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 00102 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 00103 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 00101 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 00102 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 00103 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
other: redness
Basis:
animal: 00101 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: redness
Basis:
animal: 00102 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: redness
Basis:
animal: 00103 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 00101 Male
Time point:
other: Mean 24, 48 and 72
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal: 00102 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal: 00103 Male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
other: Secreta
Basis:
animal: 00101 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: No effects observed
Irritation parameter:
other: Secreta
Basis:
animal: 00102 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: No effects observed
Irritation parameter:
other: Secreta
Basis:
animal: 00103 Male
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: No effects observed
Irritant / corrosive response data:
Ocular Reactions
The eye irritation reaction scores are shown in Table 1.
1 hour after ocular instillation of ELDEW APS-307, diffuse area of opacity was observed over approximately half to the entire area of the cornea, as well as hyperaemia of the conjunctivae, some swelling, and a large to extremely large amount of secreta. 24 hours after ocular instillation, only hyperaemia of the conjunctivae remained, and all symptoms had disappeared 72 hours after ocular instillation.
Other effects:

During the study period, there were no significant changes in body weight.

Any other information on results incl. tables

General observation of symptoms:

During the study period, there were no abnormalities in clinical signs observed.

Measurement of body weight:

.

During the study period, there were no significant changes in body weight.

Eye irritation:

1 hour after ocular instillation of ELDEW APS-307, diffuse area of opacity was observed over approximately half to the entire area of the cornea, as well as hyperaemia of the conjunctivae, some swelling, and a large to extremely large amount of secreta. 24 hours after ocular instillation, only hyperaemia of the conjunctivae remained, and all symptoms had disappeared 72 hours after ocular instillation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
To investigate the eye irritation potential of ELDEW APS-307, a primary eye irritation study was implemented using rabbits and risk was assessed. Upon doing so, ELDEW APS-307 was categorized as “R-phrase is not required: Not irritating to eyes.”
Executive summary:

In accordance with OECD 405 the registration substance is not considered to be an irritant to the eyes of rabbits.