Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (public available peer reviewed source). The original source is not available and has not been reviewed.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1,3-Dichlorobut-2-ene - CAS No: 926-57-8
Author:
OECD SIDS
Year:
2007
Bibliographic source:
SIDS Initial Assessment Report for 22th SIAM, UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In order to confirm the results of in vitro International CorrositexTM assay, a follow-up in vivo study was conducted in one rabbit to confirm this result. Two sites were tested, one for 3 minutes and one for one hour.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-dichlorobut-2-ene
- Analytical purity: 98.088%

Test animals

Species:
rabbit
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
other: The adjacent areas of untreated skin were used for comparison.
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
One test site was designated for a 3-minute exposure period and the other for a 1-hour exposure period.
Observation period:
The test sites were evaluated and scored after patch removal and approximately 24, 48, and 72 hours after the end of the exposure periods.
Number of animals:
1
Details on study design:
SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Results
Irritation parameter:
other: no data
Irritant / corrosive response data:
The test substance produced mild erythema but no edema after a 3-minute exposure period. At 24 hours after test substance removal, moderate erythema and moderate edema were observed. At 48 and 72 hours, moderate erythema and severe edema were observed.
Moderate erythema and severe edema were observed after the 1 hour of exposure to the test substance. Necrosis was observed at 24, 48, and 72 hours after test substance removal. The rabbit also exhibited severe erythema, severe edema, or a raw area during the study. Microscopic examination of the 3-minute test site revealed multifocal minimal epidermal ulceration with degeneration of adjacent collagen and diffuse mild epidermal hyperplasia. Microscopic examination of the 1-hour test site revealed severe transmural (epidermis and dermis) necrosis with hemorrhage and edema.

Any other information on results incl. tables

On the basis of the test results, 1,3 -dichlorobut-2 -ene should be classified as C, R34 according to DSD classification criteria and Skin Corr. 1B, H314 (Causes severe skin burning) according to CLP classification criteria.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information