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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-573-4 | CAS number: 20193-20-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female rats were treated by single gavage application with the test substance (solved in 0.5% CMC). The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-ethylpropylamine
- EC Number:
- 243-573-4
- EC Name:
- N-ethylpropylamine
- Cas Number:
- 20193-20-8
- Molecular formula:
- C5H13N
- IUPAC Name:
- N-ethylpropan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Aethylpropylamin
- Physical state: liquid
- Analytical purity: 99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 147 g (mean), females: 133 g (mean).
- Fasting period before study: 16 h.
- Housing: Makrolon Typ III (max. 5 animals per cage).
- Diet: standard pellet-feed ad libitum.
- Water: ad libitum.
- Acclimation period: 3 - 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21- 23 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% CMC (carboxymethyl cellulose) aqueous solution
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 237, 348, 511, 750, 2370, 7500 mg/kg bw
- No. of animals per sex per dose:
- 5 female animals (237, 2370, 7500 mg/kg bw); 5 male and 5 female animals (348, 511, 750 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Probit-analysis according to Finney
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 496 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 456 - <= 540
- Remarks on result:
- other: Mortality and different clinical signs (inclusive local effects) occurred;
- Mortality:
- 237 and 348 mg/kg bw: No mortality occurred.
511 mg/kg bw: 2 males and 2 females died within 24 h and a further animal each within 7 days.
750 mg/kg bw: All animals died within 24 h.
2370 mg/kg bw (females only): 1 female died within 1 h and all other female animals died within 24 h.
7500 mg/kg bw (females only): 4 females died within 1 h and the other female animal died within 24 h. - Clinical signs:
- other: From 348 mg/kg bw onwards: apathy, ataxia and reduced pain reactions. 511, 750 and 2370 mg/kg bw: 2 h post application: catalepsia (until > 5 h and < 24 h) 7500 mg/kg bw: immediately post application: tonic-clonic convulsions. Sporadic breathing difficul
- Gross pathology:
- 511 and 750 mg/kg bw: stomach filled with yellow-reddish liquid. Stomach mucosa reddened or peeled off, partially blood in stomach and bowel.
2370 and 7500 mg/kg bw: Stomach and overlaying organs appear to be fixated, partially dark red lungs.
Sacrificed animals: No abnormalities.
Any other information on results incl. tables
Mortality:
| Dose (mg/kg bw) | gender | dead within 1h | dead within 1 day | dead within 2 days | dead within 7 days | dead within 14 days | |
| 237 | male | - | - | - | - | - | |
| 237 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 348 | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 348 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 511 | male | 0/5 | 2/5 | 2/5 | 3/5 | 3/5 | |
| 511 | female | 0/5 | 2/5 | 2/5 | 3/5 | 3/5 | |
| 750 | male | 0/ | 5/5 | 5/5 | 5/5 | 5/5 | |
| 750 | female | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 | |
| 2370 | male | - | - | - | - | - | |
| 2370 | female | 1/5 | 5/5 | 5/5 | 5/5 | 5/5 | |
| 7500 | male | - | - | - | - | - | |
| 7500 | female | 4/5 | 5/5 | 5/5 | 5/5 | 5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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.
