tris[3-bromo-2,2-bis(bromomethyl)propyl] phosphate

Acute Toxicity: inhalation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Test guideline 2

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

Test material information

Constituent 1

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.