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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Early standard study, very limited documentation, exposure regimen fails to allow interpretation on the basis of current standards (4-h exposure).
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Irritant power of the principal aliphatic chlorinated solvents on rabbit skin and ocular mucosa.
Author:
Duprat P, Delsaut L & Gradiski B
Year:
1976
Bibliographic source:
Eur. J. Toxicol. 9: 171 - 177

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Acc. to Draize (described in Duprat et al., 1974)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
commercial, from Merck

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Sex: female
- Weight at study initiation: 2.4-3.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: scarified and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hours
Observation period:
no data
Number of animals:
30 animals
Details on study design:
Comparative study including various chlorinated solvents: Dermal application of 0.5 mL under occluded conditions on the scarified and intact skin. Skin was histologically examined on day 3 post-exposure.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
4.7
Max. score:
8
Irritant / corrosive response data:
Only overall rating was given (by primary irritation index), but effects specified could not be exactly allocated to the individual test substance. An appraisal was not possible but through comparison relative to the findings on the other substances involved.  For example, chloroform and perchloroethylene were graded as "severe" irritants (PI = 5.6 and 6.1, resp., of max. 8 scores), tetrachloromethane was assigned "moderate" (PI = 4.2).

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
A primary irritation index of 4.7 was measured for skin irritation of 1,2-dichloroethane in rabbits. According to CLP Regulation (1272/2008/EC) the substance was classified as irritant (GHS, cat. 2).
Executive summary:

In a primary dermal irritation study, New Zealand White rabbits (6 females) were dermally exposed to 0.5 mL of undiluted 1,2-dichloroethane for 4 hours. Animals then were observed for at least 3 days. Irritation was scored by the method of Draize. A primary irritation index of 4.7 was measured for skin irritation of 1,2-dichloroethane. According to CLP Regulation (1272/2008/EC) the substance was classified as irritant (GHS, cat. 2).