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EC number: 600-891-1 | CAS number: 1089-78-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2006 - Mar 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, rats instead of rabbits, few details in test description and reporting
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17 beta-Hydroxy-5(10)-estren-3-one
- EC Number:
- 600-891-1
- Cas Number:
- 1089-78-7
- Molecular formula:
- C18 H26 O2
- IUPAC Name:
- 17 beta-Hydroxy-5(10)-estren-3-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han:WIST
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (238 - 250 g); females (201 - 208 g)
- Fasting period before study: no data
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 54 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 477-499 mg (male animals), 402-421 mg (female animals)
VEHICLE
- Amount(s) applied: 0.7 mL
- Concentration: 0.9%
- Lot/batch no. : 4342A191
- Purity: no data - Duration of treatment / exposure:
- 24 h
- Observation period:
- The application sites were evaluated 1, 24, 48 and 72 h after removal of the patches.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 4 x 9 cm
- % coverage: approximately 10% of the body surface area of a rat
- Type of wrap: gauze
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS: 1, 24, 48, 72/74 hours (The evaluation of the application sites of the male animals was performed 2 hours later on day 5 (i.e. 72 hours after removal of the patches). This deviation is not considered to have a relevant influence to the study result because all animals were without local findings also on the earlier time points.
SCORING SYSTEM:
- Method of calculation: The scoring system recommended by the EU (Amendment of the Directive 67/548/EEC, Annex V, B.4. Acute toxicity (Skin irritation) in the version of the Directive 92/69/EEC, dated 31 Jul 1992.)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for swelling, reddening and scab formation after administration of 2000 mg/kg test substance.
- Other effects:
- 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 and gross pathological findings. After administration of the test substance a slight decrease in body weight was observed in all male animals and one female animal on day 7 of the study. This effect was reversible on day 14.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- in opinion of study director
- Executive summary:
A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg did not show irritating potential.
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