Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 22, 1999 - September 14, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted on March 22, 1996
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
96/54/EEC: Commission Directive of 30. July 1996 adapting to technical progress for the twentysecond time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Official Journal No. L 248, September 30, 1996)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Chemical name: 2,3`,4`,5`-Tetrafluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-biphenyl
Appearance: white, fine crystaline powder
Batch No.: E98224548
Analytical report: Merck KGaA, Darmstadt, PP AL OF2, Dr. Götzmann
End of release: October 31, 2000

released for toxicity studies.

Storage: tightly closed, dark, at room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test material was freshly prepared prior to application. The test material was prepared with an Ultra-Turrax device.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 166 (range from 154 to 174) g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 48-81%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
Methocel K4M Premium solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:
2000 mg/kg
No. of animals per sex per dose:
3 (m) / 3 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All the rats survived the observation period.
Clinical signs:
No signs of intoxication occurred after treatment.
Body weight:
Body weight development of the treated rats was inconspicuous.
Gross pathology:
The gross pathological examination revealed no organ alterations.

Any other information on results incl. tables

Study design

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. The test material was prepared with aqueous Methocel® K4M Premium solution as vehicle.This study was performed according to the „Acute toxic class method“ (ATC).

Results

No signs of intoxication were detected after treatment and no rat died.

The gross pathological examination revealed no organ alterations.

Conclusion

The median lethal dose (LD50), after an observation period of 14 days can be declared as ATC class 0 = > 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 2000 mg/kg.
Executive summary:

This study was performed according to GLP and is fully compliant OECD TG 423. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.