Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
housing of the animals was in individual cages, drinking water analysis was performed in September instead of August, dosing of males occurred one week prior to the completion of the female study
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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
- Storage condition of test material: Stored at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, Domaine des Oncins, 69592 L'Arbresle Cedex, France.
- Weight at study initiation: 223.9 to 243.6 g for females, and 257.6 to 296.4 g for males
- Fasting period before study: None
- Housing: Individually caged in standard cages with sawdust bedding
- Diet (e.g. ad libitum): RM1 (E)-SQC/DIETEX feed ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:Minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area of the rat
- % coverage: at least 10%
- Type of wrap if used: Piece of absorbant guaze which was protected by a pad and covered with an adhesive tape. Held in place for 24 hours.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done



TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes


Duration of exposure:
24 hours.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 animals per sex
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined clinically before the first treatment, twice on the day of treatment, and thereafter, daily. Animals were weighed on day 1, 7, 14 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Skin lesion evaluation was done daily, and full clinical examinations were done on days 2, 7, and 14. At necropsy their organs were examined macroscopically.

As the test item was expected to be non-toxic by the dermal route, a single group of 5 females was dosed at the maximum limit dose of 2000 mg/kg body weight followed by a group of 5 males dosed at the same dose level to establish that animals of this sex are not markedly more sensitive to Gluconic Acid.

Scoring system of skin lesions

Erythema and Eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to marked 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 definited raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm) extending beyond the area of exposure) 4

Statistics:
Not reported; however, not required for acute toxicity.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study in male and female Sprague-Dawley rats.
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
Mean weight gain in treated animals was normal when compared with the range of values usually found in the testing facility.
Gross pathology:
No organ or tissue gross findings were seen at necropsy.
Other findings:
No dermal reactions were observed during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1278/2008)