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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Jul - 19 Aug 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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)
Version / remarks:
adopted in 2006
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales, Düsseldorf, Germany
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
EC Number:
700-093-4
Cas Number:
176969-34-9
Molecular formula:
C6H6F2N2O2
IUPAC Name:
3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, AD Horst, The Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8 - 12 weeks
- Weight at study initiation: 159 - 193 g
- Fasting period before study: yes
- Housing: Group-wise in polycarbonate cages on low dust wood granulate bedding (Lignocel BK 8-15, Rettenmaier & Söhne GmbH & Co, Rosenberg, Germany)
- Diet: Provimi Kliba 3883 PM S15 Maus/Ratte (Kliba, 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): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% Cremophor EL in tap water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2%
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The dose level to be used as the starting dose was selected from one of four fixed levels, 5, 50, 300 and 2000 mg/kg bw. The starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3 females per step per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Several times on the day of administration and once daily thereafter. Mortality and in the event of symptoms occurring, nature, duration and intensity were recorded for each animal.
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
Statistics:
Statistical analysis was not performed.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Necropsy and pathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The substance was tested for acute oral toxicity in female rats according to OECD guideline 423, at dose levels of 300 and 2000 mg/kg bw. No mortality occured and the resulting LD50 was > 2000 mg/kg bw.