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EC number: 202-016-5 | CAS number: 90-80-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- reliability scoring based on 2002 guideline
- Deviations:
- yes
- Remarks:
- An insignificant deviation was that the drinking water analysis was performed in September as opposed to August as outlined in the study protocol.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-gluconic acid
- EC Number:
- 208-401-4
- EC Name:
- D-gluconic acid
- Cas Number:
- 526-95-4
- IUPAC Name:
- D-gluconic acid
- Details on test material:
- - Name of test material (as cited in study report): Gluconic Acid
- Physical state: liquid
- Analytical purity: 54.4%
- Lot/batch No.: S293E
- Expiration date of the lot/batch: 01 Aug 2014
- Stability under test conditions: Not reported
- Storage condition of test material: Stored at Room Temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud Freres Selection, La Corbiere, 49450 Roussay, France
- Weight at study initiation: 2 to 2.2 kg
- Housing: Individually caged in standard cages
- Diet (e.g. ad libitum): SDS/DIETEX STANRAB (P) SQC feed, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21
- Humidity (%): 45 to 65
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent non-treated surfaces served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test substance
- Duration of treatment / exposure:
- Gluconic Acid was applied three times successively at a duration of three minutes, one hour, and four hours, respectively (exposure of one animal)
Gluconic Acid was applied once only, at a duration of exposure of 4 hours (exposure of two additional animals). - Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsum
- % coverage: Percentage not reported; covered by gauze square of 3 X 3 cm
- Type of wrap if used: Gauze square was protected by a pad consisting of a semi-occlusive micro-porous and non-allergenic dressing and held in place with a supple and aerated fastening system consisting of elastic, adhesive, hypoallergenic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: in accordance with OECD guideline No. 404
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation preventing the grading of the erythema 4
Formation of oedema
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable; no erythema observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable; no edema observed
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animals throughout the observation period.
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Classified
- Remarks:
- Criteria used for interpretation of results: other: CLP (EC 1278/2008)
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