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EC number: 849-290-8 | CAS number: 9001-97-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-09-2007 to 08-11-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- 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
- Reference substance name:
- Active enzyme protein of 1,4-alpha-glucan 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 1,4-alpha-glucan branching enzyme (CAS no.9001-97-2 , EC name 1,4-alpha-glucan branching enzyme, Enzyme class no. 2.4.1.18)
- 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
- 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
- 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
- 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
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Not necessary since they are reconstructed skin membranes
- Remarks:
- SPF bred New Zealand White albino rabbits.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- 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, 72 hours and at 7 and 14 days after treatment.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: The test substance was distributed over a cotton gauze patch. The patch loaded with the test substance was fixed to the selected application site by means of semi-occlusive, adhesive tape. Subsequently, the entire trunk of the rabbit was wrapped with a self-adhesive-gauze to maintain the patch in position and to retard evaporation of volatile substances.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was cleaned with a tissue moistened with water.
- Time after start of exposure: Exposure time 4 hours. Observation period post-exposure: 1, 24, 48, 72 hours and at 7 and 14 days.
SCORING SYSTEM:
- Method of calculation: The resulting skin reactions were evaluated by the method of Draize et al. (J. Pharrnacol. Exp. Ther. 82 (1944) 377-390.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 1,4-alpha-glucan branching enzyme, batch PPY27209 is not irritating to (human) skin. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 1,4-alpha-glucan branching enzyme, batch PPY27209 is also not irritating to (human) skin.
- Executive summary:
A sample of 1,4-alpha-glucan branching enzyme, batch PPY27209 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. 1,4-alpha-glucan branching enzyme, batch PPY27209 caused very slight erythema and very slight oedema. At 24 and 48 hours after treatment, only very slight erythema was observed in the three rabbits. At 72 hours after removal, no signs of skin irritation were observed in any of the three rabbits.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 1,4-alpha-glucan branching enzyme, batch PPY27209 is not irritating to (human) skin. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 1,4-alpha-glucan branching enzyme, batch PPY27209 is also not irritating to (human) skin.
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