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: Study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
extended exposure duration of 24 hours, no 72 hours reading after patch removal.
GLP compliance:
no
Remarks:
(Study performed prior to implementation of GLP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing: Animals were housed individually
- ERKA 8300 feed (Robert Koch OHG, Hamm, Germany)
- Diet: ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved on two sides and one side was abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of the unchanged test item
Duration of treatment / exposure:
24 hours
Observation period:
48 hours (reading at 0,24 and 48 hours after patch removal)
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: Two sides, each 2.5 x 2.5 cm
- Type of wrap if used: surgical patch on a piece of plaster

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM
- Draize scoring system (OECD 404)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
other: mean 24/48 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded and non abraded skin
Irritation parameter:
edema score
Time point:
other: mean 24,48 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded and non abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24/48 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: abraded and non abraded skin

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present skin irritation study with the undiluted test item Sodium ethylenesulphonate, only slight skin irritation was observed in one of six rabbits both on intact and abraded skin which was fully reversed within 48 hours after patch removal.