Registration Dossier

Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 March 2009 - 05 August 2009
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed in compliance with GLP standards and according to OECD Guidelines No. 404 adopted April 24, 2002.

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guideline
according to
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

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

New Zealand White
Details on test animals and environmental conditions:
- Source: Covance Research Products, Inc., Denver, PA.
- Age at study initiation: Approximately 19 weeks
- Weight at study initiation: 2.8-3.3 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

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

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

Test system

Preparation of test site:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of test item/site under a 2.5 x 2.5 cm, 4 ply surgical gauze patch.
Duration of treatment / exposure:
The test article was kept in contact with the skin for 4 hours.
Observation period:
Test sites were examined for evidence of primary irritation approximately 1, 24, 48 and 72 hours later.
Number of animals:
Details on study design:
A site of approximately 10 x 10 cm on the dorsal area of each animal was clipped free of hair. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm, 4 ply surgical gauze patch. The patch was secured with non-irritation tape. The torso was covered with a piece of porous dressing (semi-occlusive) large enough to cover the dose site with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritation tape was used to encircle the trunk of the animal. The test article was kept in contact with the skin for 4 hours, at with time the wrappings were removed. Residual test article was removed from the test site by gently washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions.
The test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours following patch removal.
Erythema and oedema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Results and discussion

In vivo

Irritation parameter:
other: numerical Draize technique (Erythema and Oedema)
Time point:
other: Sum of 1, 24, 48 and 72-hr Readings
Max. score:
Irritant / corrosive response data:
No evidence of skin irritation was observed at any time follwoing the 4 hour exposure period. The substance is not classified as a skin irritant under GHS and CLP criteria.
Other effects:
No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: OECD GHS
Lipase is classified as "Non Dermal Irritant".
Executive summary:

The objective of this study was to assess the local irritant effect of Lipase when applied topically as a single dose. The study was conducted according to the method recommended in the OECD Guideline No 404, “Acute Dermal Irritation/Corrosion” and the study complied with all GLP standards.

The test article (0.5 mL) was applied to one intact site/rabbit and covered with semi-occlusive dressing. Three rabbits were used. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed and residual test article removed by gently washing. Dermal reactions were scored at 1, 24, 48 and 72 hours after patch removal. There were no erythema or edema noted at any of the scoring periods. The dermal irritation score was 0. There were no overt signs of systemic toxicity.  

GHS Classification: Not classified.