Phosphonium, tetrabutyl-, (hydrogen difluoride) (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

471-140-1

EC Name:

-

Cas Number:

121240-56-0

Molecular formula:

C16H37F2P

IUPAC Name:

hydrogen tetrabutylphosphanium difluoride

Details on test material:

Yellowish liquid; molar mass: 298.4 g/mol; purity: 95.0 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Strain: HsdCpb:Wu
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 162 -207 g
- Fasting period before study: 16 - 24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2
- Humidity (%): 55 +- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: demineralized water

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

6 (300 mg/kg), 3 (2000 mg/kg)

Control animals:

no

Details on study design:

- Application volume: 10 ml/kg bw
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

Not specified.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

other: LD50 cut-off

Effect level:

500 mg/kg bw

Mortality:

All animals dosed with 2000 mg/kg died within the first hour after administration. A dose of 300 mg/kg was tolerated by female rats without mortalities.

Clinical signs:

other: All animals dosed with 2000 mg/kg showed decreased motility, spasmodic state, increased salvation, abdominal position and labored breathing. In animals of the dose group 300 mg/kg increased salvation, decreased motility, piloerection and narrowed palpe

Gross pathology:

At 2000 mg/kg the gross pathology investigations revealed: liver brownish-black, spleen brownish-black and kidneys spotted clay-colored. No gross pathological findings were observed in animals of the dose group 300 mg/kg.


Without effect on weight gain and gross pathological findings.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

According to OECD guideline 423 the LD50 cut-off of Tetrabutylphosphoniumhydrogendifluorid is 500 mg/kg bw for rats (Category 4 of the Globally Harmonized Classification System).