Methylium, triphenyl-, tetrakis(pentafluorophenyl)borate(1-).

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 - 25 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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)

Version / remarks:

2001

Deviations:

yes

Remarks:

Temporary deviations from the maximum level of relative humidity occurred. Laboratory historical data do not indicate an effect of this deviation. The study integrity was thus not adversely affected.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004

Deviations:

yes

Remarks:

Temporary deviations from the maximum level of relative humidity occurred. Laboratory historical data do not indicate an effect of this deviation. The study integrity was thus not adversely affected.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

472-690-5

EC Name:

-

Cas Number:

136040-19-2

Molecular formula:

C24BF20.C19H15

IUPAC Name:

Methylium, triphenyl-, tetrakis(pentafluorophenyl)borate(1-).

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 174 - 229 g
- Fasting period before study: overnight (max. 20 hours)
- Housing: group housing of 3 animals per Macrolon cage containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 23 C
- Humidity (%): 41 - 91%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: based on trial formulations and on test substance data supplied by the sponsor.
- Specific gravity: 1.036

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION (if unusual): formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle.

Doses:

2000 mg/kg, 300 mg/kg, 300 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: at periodic intervals on the day of dosing and once daily thereafter until day 15
body weight: days 1 (pre-administration), 8, 15 and at death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

300 - 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg, all 3 animals died. In the first 300 mg/kg group, 1 animal died. In the second 300 mg/kg group, no animals died. All decedents were found between days 2 and 3 post-treatment.

Clinical signs:

other: At 2000 mg/kg: lethargy, hunched posture, uncoordinated movements, piloerection, ptosis At 300 mg/kg: hunched posture, piloerection The surviving animals had recovered from the clinical signs on days 3 or 6.

Gross pathology:

Macroscopic examination of the non-surviving animals treated at 2000 mg/kg revealed abnormalities in the stomach (many crateriform retractions, irregular surface of the fore stomach and glandular mucosa) and in the duodenum and jejunum (irregular surface). Macroscopic examination of three surviving animals treated in the second group at 300 mg/kg revealed abnormalities in the stomach (many crateriform retractions in the fore stomach).
No abnormalities were noted in two surviving animals treated in the first group at 300 mg/kg. Incidental findings in the non-surviving animal treated in the first group at 300 mg/kg included advanced autolyses and missing organs due to cannibalism of the non-surviving animal treated at 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300-2000 mg/kg bw. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500 mg/kg bw.