Registration Dossier
Registration Dossier
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EC number: 810-472-7 | CAS number: 159325-45-8
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 October 1997 - 13 November 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 928-664-5
- EC Number:
- 928-664-5
- IUPAC Name:
- 928-664-5
- Reference substance name:
- (1S,2S,4R,6S,8S,11R,12S,14S,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-one
- Cas Number:
- 159325-45-8
- Molecular formula:
- C23H35NO2
- IUPAC Name:
- (1S,2S,4R,6S,8S,11R,12S,14S,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Epyrron
- Physical state: Off white powder
- Composition of test material, percentage of components: Main component 55%; Other 22% & 18%
- Lot/batch No.: GV-1458 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, sulzfed, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: Males (average): 369 grams; Females (average) 235 grams
- Fasting period before study: No
- Housing: Individually in polycarbonated cages
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, OUd-Turnhout, Belgium).
- Water (e.g. ad libitum): Free access tap-water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10% of total body surface
- Type of wrap if used: Gauze patch, fixed successively to aluminium foil and Coban elastic bandage; in addition micropore tape was used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap-water moistened tissue
- Time after start of exposure: 24 hours after application - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males;
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice Daily; Body Weights - Day 1 (pre-administration), day 8 and day 15; Clinical Signs - periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Internal macroscopic abnormalities
Results and discussion
- Preliminary study:
- Since the 2000 mg/kg body weight limit test resulted in no adverse effects, or mortalities in the study group, no additional dose levels were required.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality reported.
- Clinical signs:
- other: General or focal erythema, scales and scabs on the back or flank were reported in one male and two females. By day 8 the females recovered from symptoms, however scabs persisted in the male at termination of study. Yellow staining of the skin by the test
- Gross pathology:
- No treatment related abnormalities were reported at the macroscopic level.
Pelvic dilation of the kidneys were found in one male, however this is a common occurrence among rats of this age and strain and was not considered toxicologically related.
Any other information on results incl. tables
| Clinical Signs - Males | |||||||||||||||||||
| Test day | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||
| Time after treatment Hours | 0 | 2 | 4 | ||||||||||||||||
| Animal No. | Signs | Max Grade | |||||||||||||||||
| 1 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 2 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| 3 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 4 | Skin/Fur/Plumage/Erythema Focal (Back) | 4 | - | - | - | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - |
| Scabs (Back) | 3 | - | - | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| 5 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Clinical Signs - Females | |||||||||||||||||||
| Test day | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||
| Time after treatment Hours | 0 | 2 | 4 | ||||||||||||||||
| Animal No. | Signs | Max Grade | |||||||||||||||||
| 6 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 7 | Skin/Fur/Plumage/General Erythema (Back) | 4 | - | - | - | 2 | 2 | 2 | 1 | 1 | 1 | - | - | - | - | - | - | - | - |
| Scales (Back) | 3 | - | - | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | |
| Skin Yellow (Flank Left) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| 8 | Skin/Fur/Plumage/General Erythema (Back) | 4 | - | - | - | 2 | 2 | 2 | - | - | - | - | - | - | - | - | - | - | - |
| Erythemal Focal (Flank Right) | 4 | - | - | - | - | - | - | 2 | 2 | 1 | - | - | - | - | - | - | - | - | |
| Scales (Back) | 3 | - | - | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | |
| Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | |
| Skin Yellow (Flank Left) | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | 1 | 1 | 1 | 1 | |
| 9 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 10 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, when administered as supplied to 5 male and female Wistar rats, appears to have an acute dermal LD50 greater than 2000 mg/kg
- Executive summary:
The dermal LD50 value of the test substance in rats was established as exceeding 2000 mg/kg body weight.
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