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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, insufficient documentation, but result in line with findings of others.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: SIDS Initial Assessment Report
Title:
Stauffer Chemical (1973) in OECD SIDS report 1,2-dichloroethane
Author:
Anonymous
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for 14th SIAM (Paris, France, March 2002)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations Part 191.12
Deviations:
not specified
Principles of method if other than guideline:
Draize Test (Code of Federal Regulations Part 191.12)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2-dichloroethane (lot #2100-35.1), a clear colorless liquid.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand rabbits in the 1.6-2.1 kg weight range were used.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
0.1 mL of the test substance was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The lids were gently held together for one second and the animal released. The other eye remaining untreated served as control.
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
The eyes were observed at 24, 48 and 72 h following treatment and scored for irritation properties. If, at the end of 72 h ocular damage appeared to be remissible (reversible), the animal was observed for an additional 4-7 days before final scoring was possible.
Number of animals or in vitro replicates:
6 animals
Details on study design:
Eyes were not rinsed.
Eye irritation was determined according to the method of the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances." A total score of 110 was possible. A non-irritant must have a score of 10 or less.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
< 10
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: No scores given. As the substance was not regarded irritant according to the authors the score was suspected to be lower than 10.
Irritant / corrosive response data:
After application of 0.1 mL 1,2-dichloroethane into the conjunctival sac slight reddening and annular conjunctival swelling were noted in 2/6 and 1/6 animals, respectively.  All symptoms disappeared completely within three days. No rankings for findings were given. However, the minor effects suggested no irritation potential.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Eye irritation in rabbits: No rankings for findings were given. However, the minor effects suggested no irritation potential. Nevertheless, the substance was expected to have an eye irritation potential (classified GHS Cat. 2 according to Regulation 1272/2008/EC).
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 animals/dose). Eyes were not rinsed after application. Animals then were observed for 4 -7 days. Irritation was scored by the method of Draize.

After the application, slight reddening and annular conjunctival swelling were noted in 2/6 and 1/6 animals, respectively. All symptoms disappeared completely within three days. No rankings for findings were given. However, the minor effects noted suggested no irritation potential. Nevertheless, the substance was expected to have an eye irritation potential (classified GHS Cat. 2 according to Regulation 1272/2008/EC).