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EC number: 216-765-0 | CAS number: 1660-95-3
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
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- Irritation / corrosion
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- Genetic toxicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1993-03-08 to 1993-09-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study was designed to comply with FHSA standards set forth in 16 CFR 1500.40.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- 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 material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.1 to 2.7 kg
- Fasting period before study: No data
- Housing: The animals were housed 1/cage in suspended wire mesh cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled but no value available
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hour dark/light cycle
IN-LIFE DATES: From 1993-08-03 to 1993-08-27
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Test site
Prior to application of the test article, the abdomen and sides of each animal were clipped free of hair. The prepared site was approximately 10% of the body surface. The clipped site in 1/2 of the animals were abraded with a bent tip needle. Six or seven abrasions about 2-3 cm apart, extending the length of the exposure site, were made. Abrasions were sufficiently deep to penetrate the stratum corneum, but not deep enough to produre bleeding.
Treatment
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 applied to the prepared dermal site, one time, by a syringe type applicator at 1000 mg/kg of body weight. The test article was covered with a gauze patch and gentle pressure was applied to the gauze to aid the distribution of the test article over the prepared site. The torso was wrapped with plastic which was secured with tape. At 24h, the patches were removed and the site was wiped.
REMOVAL OF TEST SUBSTANCE
- the sites were wiped
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1000 mg/kg - Duration of exposure:
- 24 h
- Doses:
- 1000 mg/kg
- No. of animals per sex per dose:
- 10 (5 Males and 5 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
+The test sites were scored (Draize scale) for dermal irritation at 24h post dose and on day 7 and 14. additional signs were described.
+ The animals were observed daily for 14 days for mortality, toxicity and pharmacologicals effects.
+ Body weight were recorded pretest and at termination
+ No examination for gross pathology was performed - Statistics:
- An estimate of the LD50 was made based on mortality occuring during the study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: Instances of diarrhea, few feces and soiling of the anogenital area were noted in females. All males appeared normal during the 14 day observation period.
- Gross pathology:
- Not performed
Any other information on results incl. tables
Body weights, Dose volume and dermal reactions
N° |
Sex |
Dose(mL) |
Abraded |
Weight (Kg) |
Day 1 |
Day 7 |
Day 14 |
% rem |
||||
D0 |
D14 |
R |
E |
R |
E |
R |
E |
|||||
C7722 |
M |
2.2 |
Yes |
2.4 |
2.7 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
C7723 |
M |
2.5 |
No |
2.7 |
3.2 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
C7724 |
M |
2.1 |
Yes |
2.3 |
2.5 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
C7725 |
M |
2.4 |
No |
2.6 |
2.7 |
1 |
0 |
0 |
0 |
0 |
0 |
70 |
C7726 |
M |
2.2 |
Yes |
2.4 |
2.8 |
1 |
0 |
0 |
0 |
0 |
0 |
70 |
C7759 |
F |
2.3 |
No |
2.5 |
2.1** |
1 |
0 |
0 |
0 |
0 |
0 |
70 |
C7760 |
F |
2.2 |
Yes |
2.4 |
2.2** |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
C7761 |
F |
2.3 |
No |
2.5 |
2.6 |
2 |
0 |
0 |
0 |
0 |
0 |
70 |
C7762 |
F |
2.0 |
Yes |
2.1 |
2.4 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
C7764 |
F |
2.3 |
No |
2.5 |
2.7 |
1 |
0 |
0 |
0 |
0 |
0 |
70 |
Code: R erythema (redness), E edema, ab abraded, ** body weight verified, % Remaining a visual estimate of the amount of material remaining on the skin, gauze and occlusive binding at 24 hours, after the occlusive binding was removed.
PHYSICAL SIGNS:
Instances of diarrhea, few feces and soiling of the anogenital area were noted in females. All males appeared normal during the 14 day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 is greater than 1000 mg/kg of body weight.
- Executive summary:
The Acute Dermal Toxicity of the TIPMDP was evaluated in a GLP study following the standards set forth by FHSA, 16 CFR 1500.40. Ten healthy New Zealand Albino rabbits (5 males and 5 females) were dosed dermally with the test substance at 1000 mg/kg of body weight. The test substance was kept in contact with the skin for 24 hours. The animals were observed daily for 14 days for mortality, toxicity and pharmacological effects. Skin reactions were scored on days 1, 7 and 14. Body weights were recorded pretest and at termination.
All animals survived the 1000 mg/kg dermal application. Instances of diarrhea, few feces and soiling of the anogenital area were noted during the observation period. Body weight changes were normal in 8/10 animals. Two females lost weight during the study. Dermal Reactions, absent to well defined on day 1, were absent on days 7 and 14. The LD50 is greater than 1000 mg/kg of body weight.
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