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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 22, 2005 - March 31, 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
96/54/EC
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-3',5'-difluoro-[1,1'-biphenyl]-4-yl}-5-ethyloxane
EC Number:
616-651-4
Cas Number:
787582-75-6
Molecular formula:
C26H21F7O2
IUPAC Name:
2-{4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-3',5'-difluoro-[1,1'-biphenyl]-4-yl}-5-ethyloxane

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Weight at study initiation: 157 to 179 g
- Age at study initiation: approx. 6 to 8 weeks
- Fasting period before study: Yes (Diet was withheld from 17 hours before until up to 4 hours after treatment)
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks; conventional softwood granulate was used
- Diet: Provimi Kliba 3433.0
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22 °C
- Humidity (%): 51 to 80
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Aqueous Methocel® K4M Premium solution (2.5 g/L)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: excellent vehicle performance in long range historical data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg bw (limit test)
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 least 6 hours after administration and then checked daily; body weight: before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Body weight: Tox-511 A

Results and discussion

Preliminary study:
NA
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed. All rats survived the observation period.
Clinical signs:
other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test item.
Gross pathology:
At necropsy no organ alterations were seen.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded, that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats.
Executive summary:

The test item was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw according to OECD TG 423 under GLP conditions. No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw. All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.