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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 March 2009 - 05 August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Lipase is also used in animal feed. Thus, in vivo skin irritation study were required to assess worker safety according to the provisions of Regulation EC 429/2008. Also, the findings from these studies were used for product classification and labelling in the US (OSHA, HSC).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
Cas Number:
9001-62-1
Molecular formula:
Not applicable, see remarks
IUPAC Name:
Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
Constituent 2
Reference substance name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available
IUPAC Name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 3
Reference substance name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 4
Reference substance name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Constituent 5
Reference substance name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Test material form:
liquid
Details on test material:
- Substance type: UVCB
- Physical state: translucent tan liquid
Specific details on test material used for the study:
- Substance type: UVCB
- Physical state: translucent tan liquid

Test animals

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

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

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

Test system

Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
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:
Three
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
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:
GHS criteria not met
Conclusions:
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.

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