Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Toxicological and environmental factors involved in the selection of decabromodiphenyl oxide as a fire retardant chemical.
Author:
Norris et al.
Year:
1973
Bibliographic source:
Appl Pol Symp 22:195–219.
Reference Type:
publication
Title:
Toxicology and human health asessment of decabromodiphenyl ether
Author:
Hardy et al.
Year:
2009
Bibliographic source:
Critical Reviews in Toxicology 39(S3):1-44.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test conducted prior to international guidelines. However, performance was consistent with today's guidelines.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Former commercial product known as FR-300-BA, composed of 77% BDE209, 22% NonaBDEs, and 0.8% OctaBDEs.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
corn oil
Doses:
see below
No. of animals per sex per dose:
see below
Control animals:
yes

Results and discussion

Preliminary study:
Intragastric intubation of a single dose of a 10% corn oil
suspension of FR-300-BA to female Sprague-Dawley rats
did not affect survival at dose levels of 126, 252, 500, 1000, or
2000 mg/kg. No indication of toxicity after intubation or during
the 14-day period was observed. No gross pathological
changes were observed at necropsy carried out on 1 rat/dose
level.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Executive summary:

Intragastric intubation of a single dose of a 10% corn oil suspension of FR-300-BA to female Sprague-Dawley rats did not affect survival at dose levels of 126, 252, 500, 1000, or 2000 mg/kg. No indication of toxicity after intubation or during the 14-day period was observed. No gross pathological changes were observed at necropsy carried out on 1 rat/dose level (Norris et al., 1973).