4-Ethyl-2',3'-difluor-4''-propyl-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:

February 12, 2003 - June 23, 2003

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 December 17th, 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Commission Directive of 30th. July 1996 adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
(Official Journal of the European communities 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:4-Ethyl-2',3'-difluoro-4''-propyl-p-terphenyl
Purity: 99.9 %



TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Directly before the administration the test material was prepared with the vehicle using a mini shaker (Vortex Genie 2) and an Ultra-Turrax device (Janke and Kunkel).

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: approx. 7 to 9 weeks
- Weight at study initiation: 169 g (range from 153 to 198 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): 22°C
- Humidity (%): 48 - 68%
- 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: 200 g/L
- Amount of vehicle (if gavage): 10 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 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

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. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.This study was performed according to the “Acute toxic class method“ (ATC).

 

Results

No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg. There were no deaths during the course of the study.The gross pathological examination revealed no organ alterations.

 

Conclusion

Based on the result of this study, it is considered that the test material has a very low acute toxic potential and that the LD50 value is higher than 2000 mg/kg after oral treatment in rats.

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 oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.This study was performed according to the “Acute toxic class method“ (ATC).

 

Results

No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg. There were no deaths during the course of the study.The gross pathological examination revealed no organ alterations.

 

Conclusion

Based on the result of this study, it is considered that the test material has a very low acute toxic potential and that the LD50 value is higher than 2000 mg/kg after oral treatment in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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 selection of acute toxicity – dermal endpoint
On 15 July 2014 the Competent Authorities for REACH and CLP (Caracal) have agreed that substances that are not toxic in acute oral tests need no longer be tested for acute dermal toxicity. Caracal agreed on proposals to amend REACH Annex VIII (point 8.5.3) so that substances that have not shown oral acute toxicity up to a limit dose of 2000mg/kg bodyweight would not also require dermal data. The test material does not provide evidence for acute oral toxicity. The LD50 exceeds 2000 mg/kg bw. Therefore no further testing for dermal toxicity is justified.

Justification for selection of acute toxicity – inhalative endpoint

For acute inhalation no experimental data are available, however, these data are not required as no exposure via inhalation is assumed based on the PC profile of the substance. Therefore all most likely main routes are covered by experimental data for acute toxicity.

Other information

Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.

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.