Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Performed prior to international guidelines. Accepted under the EU RAR (2002).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Principles of method if other than guideline:
consistent with current guidelines
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DE 83R commercial product

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg/rabbit
Duration of treatment / exposure:
once
Observation period (in vivo):
see below
Number of animals or in vitro replicates:
see below
Details on study design:
each animal served as its own control

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: all animals at all time points
Time point:
other: all
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
DecaBDE is not an eye irritant.
Executive summary:

DecaBDe was instilled in the right eye of each of 6 rabbits. Observations were recorded at 1, 24, 48 and 72 hrs post treatment. No positive ocular scores were recorded over the course of the study. In consultation with the sponsor, the study was terminated at 72 hours. Based on the observations, DecaBDE is not an eye irritant.