1H-Indole, 1-[[4-[2-(hexahydro-1H-azepin-1-yl)ethoxy]phenyl]methyl]-3-methyl-5-(phenylmethoxy)-2-[4-(phenylmethoxy)phenyl]-

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole

Cas Number:

198480-21-6

Molecular formula:

C44 H46 N2 O3

IUPAC Name:

1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The test item was suspended in PEG 300 at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

One group of 3 male or 3 female rats.

Details on study design:

The animals were examined for clinical signs daily during the acclimatization period four times during test day 1 and oncel daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weight were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until the end of the study period.

Clinical signs:

Slightly ruffled fur was noted in male no.5 two and three hours after treatment. No clinical signs were evident in all other animals during the course of the study.

Body weight:

The body weight was within the range commonly recorded for this strain and age.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified based on CLP criteria

Conclusions:

The LD50 of TSE8 after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg b.w.