1-propyl-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-benzene

Endpoint summary

Description of key information

OECD 401: LD50 > 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The study was performed according to GLP and the methods applied are fully compliant with OECD TG 401.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

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: BRL Ltd. Basel
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 191-208 g, females: 154-163 g
- Fasting period before study:
- Housing: grouped
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22.5°C
- Humidity (%): 50-74 %
- Air changes (per hr): 15 / h
- Photoperiod (hrs dark / hrs light): 12/12 sark/light

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.92 g/ml
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle: standard vehicle showing good solubility and homogeneity

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pre admin (day 1) and day 8 and 15
- Necropsy of survivors performed: yes
- Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to
behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study period.

Clinical signs:

other: No signs of ill health or behavioural change were noted among the animals.

Gross pathology:

Macroscopic post martern examination of the animals at termination did not reveal any abnormalities.

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD-50 value of the test material in rats of both sexes was established to exceed 2000 mg/kg body weight.

Executive summary:

For this endpoint an experimental GLP comliant study according to OECD TG 401 was performed. The test item was administered to five rats of both sexes by oral gavage at 2000 mg/kg bw. Macroscopic examination was performed at the end of the experimental period.

No animals died during the study. No clinical signs of ill health or behavioural change were seen during the study.

The body weight gain shown by the animals over the study period was considered to that expected of normal untreated animals of the same age and strain. Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

The oral LD50 value of the test item in rats in both sexes was established to exceed 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

OECD 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

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item does not require classification as acute toxic compound according to Regulation (EC) No 1272/2008 (CLP).