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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

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:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Principles of method if other than guideline:

not relevant

GLP compliance:

yes

Test type:

standard acute 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. E7061-46
Storage: room temperature
Physical description: off white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adults Sprague-Dawley (Tac:N[SD]fBR) rats received from Taconic farms, Germantown, New -York.
Diet: Fresh tap water and Purina Laboratory Rodent Chow 5001 available ad libitum.
Room temperature: 66-70 deg F.
RH: 22-65%
12hr fluorescent light and 12 hour dark cycle.
Animal identification: ear tags and cage cards.
Body weights: 200-215 gr.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Animals were fasted overnight prior to dosing. Immediately prior to dosing, body weights ranged from 200 grams to 215 grams.
Test material was introduced directly into the stomach of each animal by means of a ball tipped intubation needle. animals were dosed (5000mg/kg) approx. 2.5 hr after initiation of the light cycle.

Doses:

5000mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

See attached file on methods

Statistics:

n/a

Results and discussion

Preliminary study:

n/a

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: The only clinical signs were chromorhinorrhea, diarrhea, chromodacryorrhea and abdominogenital staining. These clinical signs were noted only in the first 6 hours after treatment.

Gross pathology:

Effects on organs:
No treatment-related organ effects.

Other findings:

n/a

Any other information on results incl. tables

see attached document on results

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Test material is classified as practically non-toxic (the oral LD50 of the test material is judged to be greater than 5000 mg/kg) to both male and female rats.

Executive summary:

Ten Sprague-dawly rats (5 males and 5 females) were orally dosed with PB-370 as 50% (w/v) mixture in corn oil at a dosage level of 5000 mg/kg. Observations for toxicity were conducted at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for 13 days. On day 14 they were conducted once. Body weights were recoeded on days 0, 7 and 14 of the study. A gross necropsy was performed on all animals.

There were no deaths. The only clinical signs noted were chromorhinorrhea, diarrhea, chromodacryorrhea and abdominogenital staining. These symptoms appeared during the first 3 -6 hours after dosing and vanished afterwards. All rats gained weight during the study. At necropsy, no gross internal lesions were noted in any animals.

Under the conditions of the study test material is classified as practically non-toxic (the oral LD50 of the test material is judged to be greater than 5000 mg/kg) to both male and female rats.