cyclomaltodextrin glucanotransferase

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-09-2007 to 09-11-2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Branching enzyme and cyclomaltodextrin glucanotransferase belong to the same enzyme sub-subclass and based on the similarity of the two enzymes, read-across is considered fully applicable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted on 24 April 2002.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of branching enzyme (CAS no.9001-97-2 , EC name 1,4-alpha-glucan branching enzyme , Enzyme class no. 2.4.1.18)

Molecular formula:

n.a.

IUPAC Name:

Active enzyme protein of branching enzyme (CAS no.9001-97-2 , EC name 1,4-alpha-glucan branching enzyme , Enzyme class no. 2.4.1.18)

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:

- Lot/batch No.: PPY27209
- Expiration date of the lot/batch: June 2017

Test animals

Species:

rabbit

Strain:

other: SPF bred New Zealand White albino rabbits

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as is

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: Cotton gauze fixed with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was cleaned with a tissue moistened with water.
- Time after start of exposure: 4-hour exposure period.

SCORING SYSTEM:
- Method of calculation: Skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

At 1 h after removal, very slight erythema and very slight oedema were observed in the three rabbits. At 24 h and 48 h after removal, very slight erythema was observed in the three rabbits. At 72 h after removal, no signs of skin irritation were observed in any of the three rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993) and according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) Branching enzyme, batch PPY 27209 is not irritating to skin.

Executive summary:

Branching enzyme, batch PPY 27209 was tested for acute dermal irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.4 and OECD Guideline no. 404. Branching enzyme, batch PPY 27209 caused very slight erythema and very slight oedema in the three rabbits. At 72 h after treatment, all dermal effects had cleared completely.

According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993) and according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) Branching enzyme, batch PPY 27209 is not irritating to (human) skin.