1-ethoxy-2,3-difluoro-4-[trans-4-(trans-4-pentylcyclohexyl)-cyclohexyl-benzene

Endpoint summary

Description of key information

Read Across: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 9, 1997 - May 26, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Ferbuary 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Annex to Directive 92/69 EEC

Version / remarks:

Official Journal of the European Communities L383 A, Vol. 15, 29.Dezember 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Batch No.: E96017746

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: 5 to 8 weeks
- Weight at study initiation: 156 - 193g
- 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 - 21°C
- Humidity (%): 54-68%
- 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: 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:

5 (m) / 5 (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 normal.

Gross pathology:

At necropsy two rats showed either focal or diffuse grey-red discoloration of the thymus. In all other rats no organ alterations were seen.

Study design

The test material was tested for acute toxicity in rats after single 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. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401.

Results

No signs of intoxication occurred after treatment.
Body weight development of the treated rats was normal.
All the rats survived the observation period.
At necropsy two rats showed either focal or diffuse grey-red discoloration of the thymus. In all other rats no organ alterations were seen.

Conclusion

For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 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 401. 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.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For this endpoint information from a structural similar compound, 1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Read Across Infomation: LD50 > 2000 mg/kg bw

Executive summary:

For this endpoint information from a structural similar compound, 1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.

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

Additional information

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.

Justification for classification or non-classification

Based on the provided information there is no need to classified according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.