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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
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:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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)