Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic information provided.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1999
Reference Type:
secondary source
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
Sodium erythorbate(2000 mg/kg) was applied to the intact and abraded skin of six rabbits. Each test site was moistened with physiological saline just prior to dosing. After application of the test material, the exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape. The dressings were removed after 24 hour, and the amount of residual sample and signs of localized irritation were noted. The exposure area was cleaned by thorough wiping, and the rabbits were observed for signs of toxicity for signs of toxicity for 48 and 72 hrs and 14 days.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sodium Erythorbate
- Physical state: Powder

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
test site was moistened with physiological saline just prior to dosing
Details on dermal exposure:
TEST SITE
- Area of exposure:Intact and abraded skin
- Type of wrap if used:The exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure area was cleaned by thorough wiping
- Time after start of exposure: After 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no
Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 animals
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No signs of toxicity were observed.
Clinical signs:
Beahavour was normal and no signs of toxicity were observed.
Body weight:
Bodyweight gain was normal.
Other findings:
- A substantial amount of residual compound was observed 24 hours after dosing. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours.

- Consumption of feed and water were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 was >2000 mg/kg bw in this study.
Executive summary:

In an acute dermal toxicity, 6 rabbits were dermally exposed (intact and abraded skin; occlusive exposure) to 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50 = > 2000 mg/kg bw

Behaviour, body weight gain, and consumption of feed and water were normal, and no signs of toxicity were observed. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours.