4''-Butoxy-4-ethyl-2',2'',3''-trifluoro-[1,1':4',1'']-terphenyl

Endpoint summary

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:

2017

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:

12-2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Wiga GmbH, Sulzfeld, Germany
-Females (if applicable) nulliparous and non-pregnant: yes
-Age at study initiation: 9 weeks
-Weight at study initiation: 151 - 175 g
-Fasting period before study: 17-20 hours before dosing until 4 hours after treatment
-Housing: individually in Makrolon type IV cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 20 – 24
-Humidity (%): 40 – 70
-Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: From days 1 to 15

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel® K4M Premium

Details on oral exposure:

Dose volume: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 f

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: all animals were weighed before treatment (day1) and on days 2, 4, 6, 8, 11 , 13 and 15
- Necropsy of survivors performed: yes (gross pathology)

Statistics:

Standard statistical methods have been applied for data processing.

Preliminary study:

Yes: Range-finding with dose levels of 1000 or 2000 mg/kg, 1 m / 1 f for each dose level

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:

No mortality was seen

Clinical signs:

other: No clinical signs of toxicity were observed

Gross pathology:

No organ alterations were identified during the gross pathological examination

Study Design

The study was started with 2000 mg/kg in 3 female rats and continued with further 3 females treated with 2000 mg/kg. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11 , 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

Results

No mortality and no clinical signs of toxicity occurred during the course of this study. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.

Conclusion

The test item has no acute toxic potential under the conditions ofthe present study, and the LD50 value is higher than 2000 mg/kg after single oral administration in female rats.

Interpretation of results:

GHS criteria not met

Conclusions:

For regulatory purposes, the median lethal dose (LD50) can be declared as > 2000 mg/kg.

Executive summary:

This study was performed according to GLP and is fully compliant with 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 female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 423.

Justification for classification or non-classification

Provided information shows that the test material does not need to classified for acute toxicity according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.