D-glucono-1,5-lactone

Skin irritation / corrosion

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:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

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.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

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)