3-{[Alkyl(dimethyl)silyl]substituted}estratrien-17-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 15 April 2013 to 21 August 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17-DEC-2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier (53940 Le Genest St Isle, France)
- Females nulliparous and non-pregnant: no data
- Age at study initiation: 8 weeks old
- Weight at study initiation: between 191 and 200 g
- Fasting period before study: no data
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid, with sawdust bedding which was changed at least 2 times a week.
- Historical data: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: 13 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 23 April 2013 To: 08 May 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g in 10 mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL


CLASS METHOD
- Rationale for the selection of the starting dose: no data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily or on D0, 2, 7 and 14 for weighing
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

no clinical signs

Body weight:

absence of body weight gain between day 2 and day 7 (compared to historical control), but normal therafter

Gross pathology:

no effect observed at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

oral LD50 > 2000 mg/kg (rat, female, gavage in corn oil)

Executive summary:

In an acute oral toxicity study, groups of 8-week old Sprague-Dawley rats (6 females) were given a single oral dose of test substance in corn oil at dose 2000 mg/kg bw and observed for 14 days.

Oral LD50 Females > 2000 mg/kg bw