Registration Dossier
Registration Dossier
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EC number: 223-564-1 | CAS number: 3962-66-1
Acute Toxicity: dermal
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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- - 3 instead of 5 animals/sex used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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
- Reference substance name:
- 5(10)-Estrene-3,17-dione
- IUPAC Name:
- 5(10)-Estrene-3,17-dione
- Reference substance name:
- Delta-5-Norandrostendion
- IUPAC Name:
- Delta-5-Norandrostendion
- Test material form:
- not specified
- Details on test material:
- Purity not specified
Constituent 1
Constituent 2
Constituent 3
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(s) applied (volume or weight with unit): weighted test item in 1 mL liquid paraffin per 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
- Key result
- 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:
- other: No compound-related findings were observed.
- Gross pathology:
- No compound-related findings were observed.
Applicant's summary and conclusion
- Conclusions:
- 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.
- Executive summary:
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Jcl:SD rats (3/sex) were dermally exposed to Delta-5-Norandrostendion in liquid paraffin for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
No mortality occurred during the limit test.
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
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