Cholest-5-en-3-β-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 February 1998 - 19 February 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cholest-5-en-3-β-yl acetate

EC Number:

210-066-4

EC Name:

Cholest-5-en-3-β-yl acetate

Cas Number:

604-35-3

Molecular formula:

C29H48O2

IUPAC Name:

(1R,3aS,3bS,7S,9aR,9bS,11aR)-9a,11a-dimethyl-1-[(2R)-6-methylheptan-2-yl]-1H,2H,3H,3aH,3bH,4H,6H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-yl acetate

Test material form:

solid: particulate/powder

Details on test material:

Description: White crystalline powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany (strain Crl: (WI) BR (outbred, SPF-Quality))
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: males: 313 - 335g; females: 185 - 206g
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages.
- Diet: Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water: Free access to tap-water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): Approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION: The formulations were prepared immediately prior to dosing. Adjustment was made for specific gravity of vehicle (1.036). Homogeneity was accomplished to a visulally acceptable level.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weghts: Days 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed by asphyxiation using a oxygen/carbon dioxide procedure and subjected to necropsy. Description of all internal macroscopic adnormalities were recorded.

Statistics:

Not performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Lethargy and uncoordinated movements were noted in all animals on day 1 only. In addition, in one female rales was observed on day 1, and alopecia on days 6 to 9 inclusive. One male showed rales on day 2, 7 and 8 of the study period. Salivation was observ

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

In an acute oral toxicity study with male and female rats, performed according to OECD 423 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.

Executive summary:

Cholesteryl acetate was tested at 2000 mg/kg bw in an acute oral toxicity study with 3 male and 3 female rats, performed according to OECD 423 test guideline and GLP principles.

No mortality occurred. Lethargy and uncoordinated movements were noted in all animals on day 1 only. In addition, in one female rales was observed on day 1, and alopecia on days 6 to 9 inclusive. One male showed rales on day 2, 7 and 8 of the study period. Salivation was observed in one male immediately after treatment. This finding is occasionally seen after treatment by oral gavage and is considered not toxicologically significant. All animals showed expected gains in bodyweight over the study period and no abnormalities were noted at necropsy.

Based on the results, an LD50 >2000 mg/kg bw was determined and Cholesteryl acetate does not have to be classified for acute oral toxicity according to Regulation (EC) No. 1272/2008.