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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-11-04 to 2014-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF 8147
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
EC Number:
813-142-0
Cas Number:
1417782-28-5
Molecular formula:
C15 H10 Cl F3 O2
IUPAC Name:
1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76
- Expiration date of the lot/batch: October 01, 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Storage Stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han) SPF
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: 185 - 194 g (mean 190.7 g)
- Fasting period before study: at least 16 hours
- Housing: Single housing
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: undiluted or 20 g/100 mL
- Amount of vehicle: 1.52 mL/kg bw if administered undiluted and 1.50 mL/kg bw at a dose of 300 mg/kg bw.
- Justification for choice of vehicle: Solution in corn oil Ph.Eur.

MAXIMUM DOSE VOLUME APPLIED: 1.52 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Request of the sponsor
Doses:
300 and 2000 mg/kg bw
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: Observations daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 in both 2000 mg/kg bw test groups and in the single 300 mg/kg bw test group.
Clinical signs:
Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 4 after administration. These findings were seen again in one animal on day 1, in another animal from hour 5 until day 1. Additionally cowering position was observed in one animal from hour 4 until hour 5 only.
Clinical signs in the second 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 5. In one animal these findings persisted until study day 2 after administration.
Clinical signs in the single 300 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 3 or/and 5 after administration.
Body weight:
The mean body weight of all test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met