Registration Dossier
Registration Dossier
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EC number: 243-573-4 | CAS number: 20193-20-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
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:
- Standardised study (BASF test) to determine the acute toxicity of the test item in male and female mice after single i.p. application (observation period: 14 days).
- GLP compliance:
- no
- 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:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA
- Housing: Makrolon Typ II (max. 5 animals per cage)
- Diet: standard pellet feed for rats and mice 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:
- intraperitoneal
- Vehicle:
- other: 0.5% CMC (carboxymethyl cellulose) aqueous solution
- Doses:
- 23.7, 34.8, 51.1, 75.0, 110, 162 mg/kg bw
- No. of animals per sex per dose:
- 5 male animals (23.7 mg/kg bw); 5 male and 5 female animals (34.8, 51.1, 75.0, 110, 162 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 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:
- 60.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 48.8 - 74.4
- Remarks on result:
- other: Mortality and several clinical signs observed.
- Mortality:
- 23.7 mg/kg bw: no mortality observed.
38.4 mg/kg bw: 2 males died within 7 days.
51.1 mg/kg bw: 2 males and 1 female died within 7 days and a further male within 14 days.
75.0 mg/kg bw: 3 males and 3 females died within 7 days.
110 mg/kg bw: 1 female died within 24 h, 3 males within 48 h. 3 further females and 1 further male died within 7 days.
162 mg/kg bw: 4 males and 2 females died within 24 h, 1 further male and 1 further female died within 48 h, the last 2 females died within 7 and 14 days. - Clinical signs:
- 34.8 mg/kg onwards: apathy, ruffled fur, tight eyelids. After 12 days all animals were considered as normal.
- Body weight:
- All surviving animals gained normal weight.
- Gross pathology:
- dead animals: 30 dead animals, necropsy was not performed with 6 animals (autolysis and /or nibbled), 11 mice were without findings
110 mg/kg: Gastro-intestinal region filled with green-blackish content.
162 mg/kg: Intestine partially reddened, mesenteric vascular walls clearly visible. 1 animal with green-blackish filled gastro-intestinal region. A further animal had dark red left testis and epididymis.
sacrificed animals: No abnormalities.
Any other information on results incl. tables
Mortality:
| Dose (mg/kg) | gender | dead within 1h | dead within 1 day | dead within 2 days | dead within 7 days | dead within 14 days | |
| 23.7 | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
| 23.7 | female | - | - | - | - | - | |
| 34.8 | male | 0/5 | 0/5 | 0/5 | 2/5 | 2/5 | |
| 34.8 | female | 0/5 | 0/5 | 0/5 | 0/0 | 0/5 | |
| 51.1 | male | 0/5 | 0/5 | 0/5 | 2/5 | 3/5 | |
| 51.1 | female | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 | |
| 75.0 | male | 0/5 | 0/5 | 0/5 | 3/5 | 3/5 | |
| 75.0 | female | 0/5 | 0/5 | 0/5 | 3/5 | 3/5 | |
| 110 | male | 0/5 | 0/5 | 3/5 | 4/5 | 4/5 | |
| 110 | female | 0/5 | 1/5 | 1/5 | 4/5 | 4/5 | |
| 162 | male | 0/5 | 4/5 | 5/5 | 5/5 | 5/5 | |
| 162 | female | 0/5 | 2/5 | 3/5 | 4/5 | 5/5 |
Applicant's summary and conclusion
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.
