Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
not relevant
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-060-1
EC Name:
-
Cas Number:
19186-97-1
Molecular formula:
C15 H24 O4 P Br9
IUPAC Name:
tris[3-bromo-2,2-bis(bromomethyl)propyl] phosphate
Constituent 2
Reference substance name:
4130601
IUPAC Name:
4130601
Details on test material:
Identity: PB-370
Reference No.: E8200-58
Storage: Room temperature
Purity: 100%
Physical description: Fine white powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult Sprague-Dawley (Ctl:CDBR VAF Plus) received from Charles River Labs. Kingston NY.
Diet: Fresh tap water and Purina Labortory Rodent Chow 5001 were available ab libitum.
Animals were acclimated for a minimum of 5 days prior to study start.
Temperature: 63-77 Deg F
RH: 37-71%
Animal identification was established by the use of ear tags and cage cards.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Remarks:
see attached document on exposure system and monitoring
Vehicle:
air
Remarks:
Breathing grade compressed
Details on inhalation exposure:
Whole body exposure, BGI Wright Dust Feeder II
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
12.1 mg/L (nominal)
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
See attached document on methods
Statistics:
see attached document on methods

Results and discussion

Preliminary study:
n/a
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.81 mg/L air
Exp. duration:
4 h
Mortality:
Male: 1.8 mg/L; Number of animals: 5; Number of deaths: 0
Female: 1.8 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: There were no significant clinical signs noted during or after the exposure to the test material. A few non-significant clinical signs were noted during the exposure; upon removal from the chamber and at one h
Body weight:
All animals gained weight on day 14
Gross pathology:
Effects on organs:
No treatment-related organ effects.
Other findings:
see attached document on results

Any other information on results incl. tables

see attached document on tables and figures

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material caused no mortality when administrated for 4 hours to Sprague Dawley rats at a mean gravimetric analytically determined chamber concentration of 1.81 mg/l
Executive summary:

A group of five male and five female Sprague-Dawley rats was exposed to a respirable particulate
atmosphere of PB-370 for 4 hours at a mean, maximum-attainable concentration of 1.81 mg/l in a
dynamically-operated, whole-body inhalation exposure chamber. Gravimetric airborne test material
samples were taken at approximately 30 minute intervals during the exposure. Particle size
samples were taken twice during the exposure. Observations for toxicity and mortality were .
performed frequently during the exposure, upon removal of the rats from the chamber, at one hour
post-exposure and twice daily thereafter for 13 days; on day 14 observations were performed once.
Individual body weights were recorded immediately prior to exposure on day 0 and on days 1, 2, 4, 7
add 14. On day 14, all animals were sacrificed and gross necropsy examinations were performed.

There were no significant clinical signs noted during or after the exposure to the test material. A few
non-significant clinical signs were noted during the exposure, upon removal from the chamber and at
one hour post-exposure including abdominogenital staining, chromorhinorrhea, dust on fur,
lacrimation and squinting eyes. All animals recovered by study day 1 and remained healthy through
study termination.

All animals gained weight by termination on day 14. There were no gross internal lesions noted in
any animal at necropsy.

Under the conditions of this study, the test material caused no mortality at a mean maximum
attainable concentration of 1.81 mg/l.