1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene

Endpoint summary

Description of key information

The test material has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.

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:

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

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 - 193 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 - 21
- 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 bw

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:

other: No signs of intoxication occurred after treatment.

Body weight:

other body weight observations

Remarks:

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.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.

Executive summary:

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. 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. For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The guideline and GLP conform study is of sufficient quality to address the endpoint.

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

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. 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. For regulatory purposes, the median lethal dose (LD50), after an observation period of 15 days can be declared as > 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item does not require classification for acute toxicity via the oral route according to Regulation (EC) No 1272/2008 (CLP).