trans,trans-2,3',4',5'-Tetrafluor-4-(4'-propylbicyclohexyl-4 -yl)-biphenyl

Endpoint summary

Description of key information

The LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rats after oral administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted on March 22, 1996

Deviations:

no

Qualifier:

according to guideline

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. QA statement)

Test type:

acute toxic class method

Limit test:

yes

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.

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system 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

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and Guideline conform study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the data provided, the test item is not classified for acute oral toxicity according to Regulation (EC) No 1272.