1,2-dichloroethane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-dichloroethane

EC Number:

203-458-1

EC Name:

1,2-dichloroethane

Cas Number:

107-06-2

Molecular formula:

C2H4Cl2

IUPAC Name:

1,2-dichloroethane

Details on test material:

1,2-dichloroethane, "pure" (for spectroscopy)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Sex: female
- Weight at study initiation: 2.4-3.0 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted
amount applied: 0.1 mL

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

Eyes were not rinsed. Comparative study including various chlorinated solvents, 6 animals used per test. For evaluation of irritating effects, a primary irritation index was derived by means of the "Draize Score" on a scale from 0-110 scores. The range of categorisation for "mild" irritant was given as 4 

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not indicated

Score:

7

Max. score:

110

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: total observation time: 14 days

Irritant / corrosive response data:

After instillation of 0.1 mL of 1,2-dichloroethane into the conjunctival sac, moderate lacrimation, mild-moderate catarrhal conjunctivitis and corneal epithelium abrasion were visible in the slit lamp using fluorescein. On day 7 after instillation, keratitis was still evident, but regenerating, and fully disappeared after another 7 days. The effects were graded as "mild" with an overall irritation index of 7 (of 110 scores). [note: chloroform reached an index of 41 (of 110 scores).]

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Eye irritation test with 1,2-dichloroethane in female rabbits. The effects were graded as "mild" with an overall irritation index of 7 (of max. 110 scores).  

Executive summary:

In a primary eye irritation study, 0.1 mL of undiluted 1,2-dichloroethane was instilled into the conjunctival sac of new Zealand rabbits (6 females). Eyes were not rinsed. Animals then were observed for 14 days. Irritation was scored by the method of Draize. After instillation, moderate lacrimation, mild-moderate catarrhal conjunctivitis and corneal epithelium abrasion were visible in the slit lamp using fluorescein. On day 7 after instillation, keratitis was still evident, but regenerating, and fully disappeared after another 7 days. The reversible effects were graded as "mild" with an overall irritation index of 7 (of max. 110 scores). Under the conditions of this study, 1,2 -dichloroethane was a mild eye irritant in rabbits.