cyclomaltodextrin glucanotransferase

Endpoint summary

Description of key information

Data for cyclomaltodextrin glucanotransferase are based on read-across to branching enzyme. Both enzymes belong to the same enzyme sub-subclass IUB 2.4.1 and are considered similar with respect to their irritation potential and thus read-across is considered applicable.

Branching enzyme, IUB 2.4.1.18 was tested for both skin and eye irritation in rabbits and was found not to be irritating to either of the two.

Based on these results, cyclomaltodextrin glucanotransferase should also be classified as 'non-irritating' to eyes and skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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.

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)

Species:

rabbit

Strain:

other: SPF bred New Zealand White albino rabbits

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)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

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.

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.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-09-2007 to 13-11-2007

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Adopted on 24 April 2002.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: SPF bred New Zealand White albino rabbits

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: males, young adult
- Weight at study initiation: 1993, 1911 and 1886 g
- Housing: Individually in stainless steel cages with perforated floor.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): An amount of ca 0.1 mL of the test substance was instilled in the conjunctiva! cul-de-sac of the right eye.
- Concentration (if solution): undiluted test sample, 7.3% TOS.

Duration of treatment / exposure:

After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.

Observation period (in vivo):

1, 24, 48, 72 h after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

Only rabbits without observable eye defects were used. The study was carried out with three rabbits (started with one rabbit and continued with two rabbits ca 1 hour later) and each rabbit was treated as follows: An amount of ca 0.1 mL of the test substance was instilled in the conjunctiva! cul-de-sac of the right eye. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The reactions of the test eyes were judged at circa 1, 24, 48, 72 h after treatment

SCORING SYSTEM:

CORNEA
Opacity-degree of density (area most dense taken for reading)
No opacity ............................................................................................................................ 0
Scattered or diffuse areas, details of iris clearly visible ..................................................... 1
Easily discernible translucent area, details of iris slightly obscured ................................... 2
Opalescent areas, no details of iris visible, size of pupil barely discernible ....................... 3
Opaque, iris invisible ............................................................................................................ 4
Area of cornea affected
One quarter (or less) but no zero ........................................................................................ 1
Greater than one quarter but less than half.......................................................................... 2
Greater than half, but less than three quarters .................................................................... 3
Greater than three quarters, up to whole area ..................................................................... 4

IRIS
Normal .................................................................................................................................... 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these
or combination of any thereof) iris still reacting to light (sluggish reaction is positive).......... 1
No reaction to light, haemorrhage, gross destruction (any or all of these) ........................... 2

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Vessels normal ....................................................................................................................... 0
Vessels definitely injected above normal ............................................................................... 1
More diffuse, deeper crimson red, individual vessels not easily discernible ......................... 2
Diffuse beefy red .................................................................................................................... 3
Chemosis
No swelling ...............................................................................................................................0
Any swelling above nominal (including nictitating membrane) ................................................. 1
Obvious swelling with partial eversion of lids ......................................................................... 2
Swelling with lids about half closed ..... ................................................................................... 3
Swelling with lids about half closed to completely closed .. .................................................... 4

OCULAR DISCHARGE
No discharge ..............................................................................................................................0
Any amount different from normal (does not include amounts
observed in inner canthus of normal animals) ...........................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids ........... ............................ 2
Discharge with moistening of the lids and hairs, and considerable area around the eye ........ 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

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 (human) eyes.

Executive summary:

Branching enzyme, batch PPY 27209 was tested for acute eye irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.5 and OECD Guideline no. 405. Branching Enzyme, batch PPY 27209 caused slight redness of the conjunctivae in the three rabbits. At 48 h after treatment, all eye 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) eyes.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Not classified.