Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from March to April 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- 3 instead of 5 animals/sex used
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oestr-5(10)-ene-3,17-dione
EC Number:
223-564-1
EC Name:
Oestr-5(10)-ene-3,17-dione
Cas Number:
3962-66-1
Molecular formula:
C18H24O2
IUPAC Name:
(3aS,3bR,9bS,11aS)-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,7H,8H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1,7-dione
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Jcl:SD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 7 weeks (male), 10-11 weeks (female)
- Weight at study initiation: 257-288 g (male), 264-272 g (female)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7-22.8
- Humidity (%): 42-57
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: liquid paraffin
Details on dermal exposure:
TEST SITE
- Area of exposure: 4 x 9 cm
- % coverage: 10% of body surface
- Type of wrap: gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing: rinsed out with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: yes

VEHICLE
- Amount applied: 1 ml/animal
- Lot no.: 2Y28
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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: at least once daily (clinical signs, mortality) or once weekly (weighing)
- Necropsy of survivors performed: yes

Statistics:
none (limit test)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died in the course of the study.
Clinical signs:
No compound-related findings were observed.
Body weight:
No compound-related effects were observed.
Gross pathology:
No compound-related findings were observed.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.