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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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
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 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: 237-278 gr.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Physiological Saline

Details on dermal exposure:

Test material was weighed onto an 8 ply 2X2 inch gauze pad and moistened with physiological saline. The gauze was positioned on the intacttest site and held in place with hypoallergenic tape. The test site was covered with an elastic bandage which was lined with plastic for approx. 24 hr. The animals were dosed approx. 3 hr after initiation of the light cycle. The bandages and pads were removed and the test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water approx. 24 hr after application.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

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:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Clinical signs noted during the study included chromodacryorrhea, chromorhinorrhea, and diarhea during the first two days.

Gross pathology:

Effects on organs:
No treatment-related organ effects were observed.

Other findings:

Signs of toxicity (local):
No irritation was noted on any test site at any time during
the study.

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:

The test material is classified as relative non-toxic (the LD50 is greater than 2000 mg/kg ) to both male and female when topically applied.

Executive summary:

Ten Sprague-Dawley rats (5 male and 5 females) were treated with PB-370 at 2000 mg/kg. The test material was in contact with the intact skin for 24 hr under occlusive wrap. Observations for toxicity were conducted at 0.5, 1, 2, 3, 4 and 6 hr on the day of dosing and twice daily thereafter for 13 days; on day 14 they were conducted once. A description of the local irritation was recorded on day 1, 3, 7 and 14. Body weights were recorded on days 0, 7, and 14 of the study. A gross necroscopy was performed on all animals.

There were no deaths. The only clinical signs noted were chromodacryorrhea, chromorhinorrhea and diarrhea shortly after dosing. All rats recovered by study day 3 and remained healthy until termination. All rats gaind weight during the study. No irritation was noted on any of the test sites. All animals appeared normal at necropsy/

The test material is classified as relative non toxic (the LD50 is greater than 2000 mg/kg) to both male and female rats when topically applied.