Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in 1998
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(5-hydroxy-1,3-dimethyl-1H-pyrazol-4-yl)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone
EC Number:
609-256-3
Cas Number:
365400-11-9
Molecular formula:
C14H13F3N2O4S
IUPAC Name:
(5-hydroxy-1,3-dimethyl-1H-pyrazol-4-yl)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: Stability of the test substance in vehicle was analytically confirmed for 4 h. It was further confirmed that the test substance was homogeneously distributed in the formulation.

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:
No clinical signs were noted in the course of the study.
Body weight:
No effects on body weight development were noted.
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:
CLP: not classified; an LD50 > 2000 mg/kg bw (LD50 cut-off of 5000 mg/kg bw according to OECD 423) was determined