Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 March 2009 - 05 August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed in compliance with GLP standards and according to OECD Guidelines No. 405, adopted April 24, 2002.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Substance type: UVCB
- Physical state: translucent tan liquid
- Stability under test conditions: The undiluted test material and dilutions in water (50 and 25%) are stable for at least 5 hours at room temperature. The undiluted test material is stable at least 7 days at 4 degrees Celsius
- Storage condition of test material: Approximately minus 20 degrees of C in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA.
- Age at study initiation: Approximately 19 weeks
- Weight at study initiation: 2.8 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 March 2009 To: 28 March 2009

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral eye served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Eyelids were held together for about one second and then released.
Observation period (in vivo):
Assessment of ocular damage/irriation was made at 1, 24, 48 and 72 hours post dose.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Calculated from the weighted Draize scale
TOOL USED TO ASSESS SCORE: Mini-Maglite® flashlight; fluorescein at the 24 hr observation interval with ultraviolet light source.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: No ocular effects were noted during the study
Irritant / corrosive response data:
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted as discharge at the 1-hour reading in 1/3 eyes, cleared by 24 hours.
No other ocular effects were observed in any of the three animals at any time during the study. The substance is not classified as an eye irritant under GHS criteria based on the results of this study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Lipase should be classified as "Non Irritant".
Executive summary:
The study was conducted according to OECD Guideline No. 405 and complied with all GLP standards.

Three New Zealand rabbits (1 female; 2 males) were used. The test article (0.1 mL) was instilled in one eye/rabbit. The eyes were scored at 1, 24, 48 and 72 hours post dosing. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The untreated eye served as control.

There were no effects on cornea or iris at any scoring time. Conjunctival irritation, noted as discharge at the 1-hour reading in one animal only, cleared by 24 hours. The eye irritation score based on the 24, 48 and 72 hrs scoring was 0. There were no overt signs of systemic toxicity. Lipase is judged to be a non-irritant to the eye.

GHS Classification: Not classified