Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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 powder (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 48 and 72 hrs and 14 days.
GLP compliance:
not specified

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:
other: albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: test site was moistened with physiological saline
Controls:
not specified
Amount / concentration applied:
2000 mg/kg
Duration of treatment / exposure:
24 hrs
Observation period:
24hrs, 48hrs
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 5/6
Time point:
other: 24 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal: 1/6
Time point:
other: 24 hrs
Score:
1
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 24 hrs
Score:
0
Irritant / corrosive response data:
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 (COLIPA 1982).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.
Executive summary:

In a primary dermal irritation study, 6 rabbits were dermally exposed to 2000 mg/kg 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (test site moistened with physiological saline) to intact and abraded skin. Test sites were covered with an occlusive dressing for 24 hours.

No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48 hours. In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.