Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Chemical structure
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.