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EC number: 232-601-0 | CAS number: 9001-37-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive Annex I, II, III, and IV, Official Journal of the European Communities published in L 110 A, volume 36, 4 May 1993 § 3.2.6. I and § 3.2.5
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of Glucose oxidase (EC no. 232-601-0, CAS no. 9001-37-0, EC name: Glucose oxidase, Enzyme Class no. 1.1.3.4)
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Active enzyme protein of Glucose oxidase (EC no. 232-601-0, CAS no. 9001-37-0, EC name: Glucose oxidase, Enzyme Class no. 1.1.3.4)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Protein 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:
- 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:
- 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
- Name of test material (as cited in study report): Glucose Oxidase
- Lot/batch No.: R-GOx-04004
- Physical state: Clear brown liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.1 - 3.6 kg
- Housing: The animals were kept in a PPO-plast cage (Noryl®, floor area: 2576 cm2) with perforated floor. The tray under the cage was cleaned 2 times a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Initial Test: 3 minutes, 1 hour, 4 hours
Confirmatory Tests: 4 hours - Observation period:
- 72 hours
- Number of animals:
- Initial Test: 1 female
Confirmatory Test: 2 females - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Each gauze patch was secured with adhesive tape and thereafter the circumferential area of the patches was fixed with Scanpore tape. Nobafix gauze was wrapped around the trunk to secure the dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water and mild soap
OBSERVATION TIME POINTS
- 1, 24, 48, and 72 hours
SCORING SYSTEM:
- Method of calculation: The scores for erythema and oedema for the 3 readings at 24, 48, and 72 hours were obtained and divided by 3. The results are the average scores for erythema and oedema formation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal: ALL
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Initial Test: No reactions were observed at the 3-minute and 1-hour test substance application. Very slight erythema and oedema was observed in the 4-hour test site application for the 1-hour observation period and very slight erythema was observed at the same test site at the 24-hour observation period.
Confirmatory Test: Not reactions were observed at any test site or negative control site at any of the time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean score for erythema was 0.1 and the mean score for oedema was 0.0. The test substance is a non-irritant.
- Executive summary:
The acute dermal irritant effect of the test substance was carried out according to OECD Guideline 404. The initial study was carried out with one rabbit. The study was completed with two additional rabbits. 0.5 mL of the test substance was applied which is equivalen to 6.78 mg active enzyme protein/ kg bw or 35.2 enzyme concentrate dry matter/kg bw.
In the initial test, no skin reactions were observed in the 3-minute and 1-hour exposure time applications. Very slight erythema was observed in the 4-hour exposure time application at 1 and 24 hours after exposure. Very slight oedema was observed in the 4-hour exposure time application at 1 hour after exposure in the same test site. No other reactions were observed 1, 24, 48, and 72 hours after patch removal. No skin reactions were observed in any of the additional rabbits at any of the observation periods. No clinical signs were observed in the animals during daily observations. The mean score for erythema was 0.1 and the mean score for oedema was 0.0.
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