Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-855-5 | CAS number: 65928-65-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug to Nov 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 17 alpha-Cyanomethyl-17 beta-hydroxy-5(10)-estren-3-one
- EC Number:
- 613-855-5
- Cas Number:
- 65928-65-6
- Molecular formula:
- C20 H27 N O2
- IUPAC Name:
- 17 alpha-Cyanomethyl-17 beta-hydroxy-5(10)-estren-3-one
- Reference substance name:
- 612-855-5
- IUPAC Name:
- 612-855-5
- Details on test material:
- Purity not specified
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, Sulzfeld, Germany
- Weight at study initiation: males: 104 - 109 g; females: 105 – 112 g
- Fasting period before study: 17.5 - 18.5 h
- Housing: individually in conventional cages
- Diet (e.g. ad libitum): pell. Ssniff ® R / M - H; ad libitum, 24 hours per day
- Water (e.g. ad libitum): filtrated tap water; ad libitum, 24 hours per day
- Acclimation period: ≥ 7 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 55-60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2.0 mg carboxymethyl cellulose ad 1.0 mL Aqua dest.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD
acute toxic class
- Rationale for the selection of the starting dose: Limit dose - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations and weighing: All alterations of the baseline condition of the animals were recorded. All animals were checked four times on administration day and once daily on the following days up to day 21 of the test. Body weight was determined at the start (day 1), on day 8 and day 15 and at the end of the study (day 21).
- Necropsy of survivors performed: yes
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 mortality observed.
- Clinical signs:
- other: No clinical signs observed.
- Gross pathology:
- No adverse findings observed.
Any other information on results incl. tables
No animal died in the course of the study. A single oral (gavage) application of 2000 mg/kg was tolerated without compound-related clinical findings. The body weight gain on days 8, 15 and 21 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Conclusions:
- A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test item is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study according to OECD TG 423 (adopted 17 December 2001), groups (3/sex) of Wistar rats, were given a single oral dose of 5-Dehydrocyanomethylketon in 2.0 mg carboxymethyl cellulose ad 1.0 mL Aqua dest. at a dose of 2000 mg/kg bw. Animals were then observed for 21 days.
Oral LD50 Combined ≥ 2000 mg/kg bw
No mortality occurred during the conduction of this limit test.
Formulation is of low Toxicity based on the LD50 in males and females. The test item does not need to be classified with regard to acute oral toxicity.
There were no treatment related clinical signs, necropsy findings or changes in body weight.)
This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study OECD 423 in the rat.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
