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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from June to August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
- all three dose levels were testd although no mortalities occured after 2000 mg/kg in both sexes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile
EC Number:
241-083-5
EC Name:
17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile
Cas Number:
17006-17-6
Molecular formula:
C20H27NO2
IUPAC Name:
(3aS,3bR,9bS,11aS)-1-hydroxy-7-methoxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1-carbonitrile

Test animals

Species:
rat
Strain:
other: HAN:WIST (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.9 % NaCl + 0.085 % Myrj 53 in bidist. water
Doses:
25, 200 and 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No animal died in the course of the study. After single oral application 25, 200 or 2000 mg/kg no clinical findings were observed in male and female animals. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at 25, 200 and 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.

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