Pyrasulfotole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 Dec 2003 - 28 Jan 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol

EC Number:

609-256-3

Cas Number:

365400-11-9

Molecular formula:

C14H13F3N2O4S

IUPAC Name:

4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: Analysis of the test compound formulations confirmed stability at room temperature for at least 4 hours and that the test compound is homogeneously distributed in the 0.5 and 200 mg/ml formulations. Suspensions had to be stirred for homogenization.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

(HsdCpb:Wu)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 162 - 170 g
- Fasting period before study: yes (16 - 24 h)
- Housing: group housing
- Diet: Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst, Switzerland (ad libitum)
- Water: tap 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

IN-LIFE DATES: From: 05 Dec 2003 To: 28 Jan 2004

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% polyethoxylated castor oil (Cremophor(R)) in demineralized water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females each in the first and second step

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Signs of poisoning and mortality rates were determined several times on the day of administration and subsequently at least once daily. Body weights were determined weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off 5000 mg/kg bw according to OECD 423

Mortality:

No mortality was noted in the course of the study.

Clinical signs:

other: No clinical signs were noted in the course of the study.

Gross pathology:

No gross pathological findings were noted at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The study was performed in accordance to OECD TG 423 under GLP conditions and is considered reliable. The LD50 was determined to be > 2000 mg/kg bw (LD50 cut-off of 5000 mg/kg bw).