4''-Ethyl-2',3,4,5-tetrafluor-1,1':4',1''-terphenyl

Endpoint summary

Description of key information

OECD 423 (rat, oral) LD 50 > 2000 mg/kg bw

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:

Jun 19, 2000 - Aug 01, 2000

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)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 172 (160 - 185) g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 52 to 61
- 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:

other: Methocel KM4 Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: excellent vehicle performance in long range historical data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 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, 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.

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were seen in the 3 male and 3 female rats after treatment with 2000 mg/kg bw.

Body weight:

other body weight observations

Remarks:

Body weight development of the treated rats was inconspicuous.

Gross pathology:

At necropsy, no organ alterations were seen.

Interpretation of results:

GHS criteria not met

Conclusions:

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.

Executive summary:

Study design

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 423.

Results

There were no deaths during the course of the study. No signs of toxicity were seen in the rats (3 males, 3 females) after treatment with 2000 mg/kg body weight of the test item. The body weight development of the rats was insuspicious during the study. The gross pathological examination revealed no organ alterations.

Conclusion

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 body weight 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:

Guideline study under GLP conditions

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

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity it is not considered to be classified according Regulation (EC) No 1272/2008.