Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1952

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
The test material was administered to both eyes, after approximately 30 seconds one eye was flushed with copious amounts of running water for 3 minutes. Both eyes were stained and observed for injury.
GLP compliance:
no
Remarks:
pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The material used in the skin contact test was of regular commercial quality having a purity of approximately 99%.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Rabbits, not otherwise specified.

ENVIRONMENTAL CONDITIONS
not reported.

IN-LIFE DATES:
not reported.

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
undiliuted, 1% and 10% solution (in water assumed).
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
2, 24 and 48 hours
Number of animals or in vitro replicates:
Not specified
Details on study design:
In this study the rabbits' eyes first were examined by using fluorescein staining to ensure that they were normal, special attention being paid to the lens and the iris, as well as to the surface of the cornea. About four hours after this preliminary check, the test material was introduced into both eyes. In about 30 seconds one eye was flushed for three minutes with copious amounts of running water, after which both eyes were stained and observed for injury as before. Examinations were repeated after 2, 24, and 48 hours and for longer periods if necessary, to determine the degree of injury and the course of the healing period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Corneal irritation (Undiluted material)
Basis:
other: All test animals
Time point:
other: not reported.
Reversibility:
fully reversible within: 48
Remarks on result:
other: A very slight amount of superficial necrosis of the cornea was observed, but healing was prompt and complete.
Irritation parameter:
other: Conjuctivae irritation (Undiluted material)
Basis:
other: All test animals
Time point:
other: not reported.
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The test material promptly caused obvious pain and conjunctival irritation which cleared completely within 48 hours.
Irritation parameter:
other: Conjunctivae irritation (10% solution in propylene glycol)
Basis:
other: All test animals
Time point:
other: within 2 hours of exposure.
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: Conjunctival irritation of moderate intensity developed within 2 hours and persisted for 48 hours before it began to subside. Healing appeared to be complete 12 days after exposure.
Irritation parameter:
other: Corneal irritation (10% solution in propylene glycol)
Basis:
other: All test animals
Time point:
other: not reported.
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: Corneal injury was of moderate to severe intensity, and persisted for 48 hours before tissure repair became apparent. Healing appeared to be complete 12 days after exposure, without corneal scarring.
Irritant / corrosive response data:
When the undiluted material was tested, it promptly caused obvious pain and conjunctival irritation, which cleared completely within 48 hours. A very slight amount of superficial necrosis of the cornea was also observed, but healing was prompt and complete. When a 10% solution of ethylene dibromide in propylene glycol was tested, it produced a more severe response than did the undiluted material. Conjunctival irritation of moderate intensity developed within 2 hours and persisted for 48 hours before it began to subside. Corneal injury was of moderate to severe intensity, and it also persisted for 48 hours before tissue repair became apparent. Healing appeared to be complete 12 days after exposure, without corneal scarring. No injury to the iris or the lens was apparent. When a 1 % solution in propylene glycol was tested, it elicited a response very similar to that of the undiluted material. Prompt washing of treated eyes had a beneficial effect in all cases, thus slightly reducing the intensity of the response and shortening the
healing time.
Other effects:
Pain, conjunctival irritation, superficial necrosis of the cornea.

Any other information on results incl. tables

No further information available.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Studies on rabbits have shown that while undiluted ethylene dibromide is not likely to cause permanent injury to the eye, it probably will cause appreciable pain and soreness for a few days. Strong solutions (10% or more) may cause more serious injury than the undiluted material.
Executive summary:

Ethylene dibromide caused obvious pain and some injury to the rabbit eye; healing, however, was complete and not prolonged.

Studies on rabbits have shown that while undiluted ethylene dibromide is not likely to cause permanent injury to the eye, it probably will cause appreciable pain and soreness for a few days. Strong solutions (10% or more) may cause more serious injury than the undiluted material.

Protection is recommended for those handling ethylene dibromide. A face shield or goggles will probably afford adequate protection. If the eyes should become contaminated, they should be flushed as quickly as possible with copious amounts of water for at least 15 minutes. Medical attention then should be obtained.