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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 1989-12-27 to 1990-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data for individual animals available in the report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This study was designed to comply with the standards set forth by FHSA, 16 CFR 1500.3(c)(2)( i).
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetraisopropyl methylenebisphosphonate
EC Number:
216-765-0
EC Name:
Tetraisopropyl methylenebisphosphonate
Cas Number:
1660-95-3
Molecular formula:
C13H30O6P2
IUPAC Name:
tetraisopropyl methylenebis(phosphonate)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace animals
- Weight at study initiation: 232 - 270 g
- Fasting period before study: Yes
- Housing: The animals were housed 5 / cage in suspended wire mesh cages. Bedding was placed beneath the cages and changed twice / week
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): Freeely available at all times
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature: Controlled temperature but no data on values
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light / dark Cycle

IN-LIFE DATES: From 1990-01-05 To 1990-01-19

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was used as received and the dose was based on the sample weight, as calculated from the specific gravity. The test article was administred orally, one time, by syringe and dosing needle at 500 mg/kg of body weight.
Doses:
500 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: Animals were observed 3-4 hours post dose and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Frequency weighing: Pretest
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality at 500 mg/kg
Clinical signs:
Soiling of the anogenital area was noted in one animal on day 1. At all other times, all animals appeared normal.
Body weight:
Not performed after treatment
Gross pathology:
No gross pathology performed at the end of the study

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 is greater than 500 mg/kg of body weight.
Executive summary:

The Acute Oral Toxicity of the TIPMDP was evaluated in a GLP study following the standards set forth by FHSA, 16 CFR 1500.3 (C) (2) (i). Ten healthy male Wistar Albino rats were dosed orally with the test substance at 500 mg/kg of body weight. Body weights were recorded pretest. Mortality and systemic observations were recorded 3 -4 hours post dose and daily thereafter for 14 days. All animals survived the 500 mg/kg oral dose in generally good health. The LD50 is greater than 500 mg/kg of body weight.