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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A code of 2 “Reliable with restrictions” was applied for the following reasons: (1) These studies were conducted before the implementation of GLP standards at the US NTP; however, a data audit was performed, and no problems were identified that affected the interpretation of the study. (2) No guideline was followed. The available OECD and Office of Prevention, Pesticides and Toxic Substances guidelines were not finalized at the time these studies were performed, but the NTP studies are generally consistent with the current guidelines. (3) The complete study report is publicly available.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Toxicology and human health assessment 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 article administered in the diet for 14 days to rats and mice.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rats and mice
Strain:
other: Fisher 344/N and B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
14 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5000, 10000, 20000, 50000, 100000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
5M/5F
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
see below
Sacrifice and pathology:
see below
Other examinations:
see below
Statistics:
see report

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
>= 100 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: 2 species: rats and mice

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The US NTP (NTP, 1986) conducted a 14-day study using groups of 5 male and 5 female F344/N rats or B6C3F1
mice. Animals were fed diets containing 0, 5000, 10000, 20000, 50000 or 100000 ppm commercial BDE-209 (99%;
The Dow Chemical Company). The doses were equivalent to 5% through 10% of the diet. Formulated or control diets and water were available ad libitum. Rats and mice
were observed daily for clinical signs of toxicity and were weighed on days 1, 7, and 14. A necropsy was performed
on all animals from control and treatment groups. Organs examined at the gross necropsy included: all gross lesions,
skin, mandibular lymph nodes, mammary glands, salivary glands, thigh muscle, sciatic nerve, sternebrae, femur or
vetebrae including marrow, costochondral junction (rib), thymus, larynx, trachea, lungs and bronchi, heart, thyroid
gland, parathyroids, esophagus, stomach, duodenum, jejunum, tissue masses, ileum, colon, cecum, rectum,
mesenteric lymph nodes, liver, gallbladder (mice), pancreas, spleen, kidneys, adrenal glands, urinary bladder,
seminal vesicles/prostate/testes or ovaries/uterus, nasal cavity, brain, pituitary gland, spinal cord, and eyes. The
test article in diet up to 100000 ppm (10%) produced no mortality, no effect on body weight, and no compoundrelated
clinical signs or gross pathologic effects (histopathology was not performed) in treated rats and mice.
Executive summary:

14 day NOEL>=100000 ppm in diet (10% of diet) in two species.