Registration Dossier
Registration Dossier
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EC number: 700-803-2 | CAS number: 14531-84-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to internationally accepted guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- max applied dose = 2000mg/kg
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- max applied dose = 2000mg/kg
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dienone
- IUPAC Name:
- Dienone
- Details on test material:
- - Name of test material (as cited in study report):Dienone
- Substance type: off-white powder
- Physical state:solid
- Analytical purity:99.5 (% by DSC)
- Lot/batch No.:C166/1 Y08696/002
- Storage condition of test material: Ambient temperature in the dark
From the information supplied by the sponsor, the test substance was used within the expiry date. A certificate of analysis is retained in the CTL Archives.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rodent Breeding Unit, Alderly Park, Macclesfield, Cheshire, UK.
- Age at study initiation: 8-12 weesk
- Weight at study initiation: Males: 389-431 Females: 182-219
- Fasting period before study: not specified
- Housing:The rats were housed individually, in multiple
- Diet (e.g. ad libitum): R&M No.1, supplied by Special Diet Services Limited, Witham, Essex, UK, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period:6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+/- 4 deg C
- Humidity (%):30-70
- Air changes (per hr):15 per hour
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: enough water to make a paste
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 7cmx7 cm
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):males- 16.0-23.8 mg/cm2; females:10-12.5 mg/cm2
- Concentration (if solution):
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit):0.4-0.7 ml water - Duration of exposure:
- 24 h
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 d
- Frequency of observations and weighing: before dosing and also Day 8 and 15.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight. macroscopic post mortem examination. This inviovled an external observation and a careful examination of all thoracic and abdominal viscera.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Conclusions:
- The acute dermal median lethal dose of dienone is greater than 2000mg/kg to male and female rats.
- Executive summary:
A group of five male and five female Alpk:APfSD (Wistar-derived) rats received a single dermal application of 2000 mg/kg of dienone.
The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their bodyweights were recorded at intervals throughout the study. At the end of the study, all the animals were killed and subjected to a macroscopic examination post mortem.
Results
None of the animals died and there were significant signs of systemic toxicity and no signs of skin irritation in any animal. All animals showed an overall weight gain during the study. There were no macroscopic abnormalities in any animal at examination post mortem.
Conclusion
The acute dermal median lethal dose of dienone is in excess of 2000 mg/kg to male and female rats.
By read across, the median lethal dose of delta-6 -nandrolone is also in excess of 2000 mg/kg.
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