Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-10-22 to 2001-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 31 July 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-860-9
EC Name:
-
Cas Number:
474510-57-1
Molecular formula:
C21 H24 O4
IUPAC Name:
2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl) benzyl) phenyl)-2-methylpropan-1-one
Details on test material:
- Description: Slightly yellow powder
- Purity/Composition: 94.1%
- Stability of test item: Stable under storage conditions
- Storage conditions: In the original container, at room temperature (range of 17-23 °C), protected from light. The test item is light sensitive and was handled in a dark room.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 12 weeks (male); 21-22 weeks (females)
- Weight at study initiation: male (mean): 2563 g; female: 3058 g
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark

IN-LIFE DATES: From: 08-Oct-2002 To: 31-Oct-2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
single treatment; the treated eyes were not rinsed after instillation
Observation period (in vivo):
72 hours (readings performed at 1 h, 24, 48, 72 hours)
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were not rinsed after instillation.


SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
other: 24,48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
female
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
female
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
female
Time point:
other: 24,48,72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
female
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
- Irritation:
Application of the test item to healthy rabbit conjunctivae resulted in a primary eye irritation score of 0.89. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean score for corneal opacity and iris was 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.33, 0.33 and 1.00 for reddening and 0.00, 0.00 and 0.00 for chemosis, respectively.
No abnormal findings were observed in the iris of any animal at any of the measurement intervals.
A slight corneal opacity, affecting up to the whole area of the cornea, was observed in the treated eye of one animal at the 1-hour examination.
Slight to moderate reddening of the conjunctivae was observed in all animals from 1 to 24 hours after treatment and continued to be observed in two animals up to the 48-hour examination. Slight to obvious swelling of the conjunctivae was apparent in all animals 1 hour after treatment.
Assessment of the sclerae was not possible in one animal at the 1 -hour examination due to swelling of the conjunctivae. Scleral reddening, of various severity (mild to marked), was however subsequently observed in all animals up to 24 hours and in two animals up to 48 hours after treatment. Increased ocular discharge was observed in all animals 1 hour after treatment. Mucus was also present in the treated eye of one animal at the 24-hour examination. No abnormal findings were observed in the treated eye of any animal 72 hours after treatment, the end of the observation period for all animals.

Other effects:
-Viability/mortality and clinical signs:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

- Coloration:
No staining of the treated eyes by the test item was observed. White remnants of the test item were observed in the eye or conjunctival sac of all animals 1 hour after treatment.

- Body weight:
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

The test item is considered to be "not irritating" to the rabbit eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information