Registration Dossier
Registration Dossier
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EC number: 205-864-4 | CAS number: 156-87-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-aminopropan-1-ol
- EC Number:
- 205-864-4
- Cas Number:
- 156-87-6
- Molecular formula:
- C3H9NO
- IUPAC Name:
- 3-aminopropan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Substance-ID: 78/701
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 220-260 g, female: 160-180 g
- Fasting period before study: 15-20 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64, 6.85, 10, 14.7, 21.5 %
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 464, 681, 1000, 1470, 2150 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: before study, after 2-4 days, 7 days and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 348 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 of 10 animals died at 464 mg/kg
1 of 10 animals died at 681 mg/kg
no animals died at 1000 mg/kg
5 of 10 animals died at 1470 mg/kg
all animals died at 2150 mg/kg - Clinical signs:
- other: clinical signs included: apathy, dyspnoea, stertorous respiration, gasping, apathy, staggering, urine of strong yellow colour, scrubby fur, anaemic paleness, blood in nose and saliva, bad general condition. Most of these clinical signs were only observed
- Gross pathology:
- The sacrificed animals were without findings.
The following findings were made in animals that died during the study:
heart: acute right dilation
liver: circumferential delineation of the liver lobes
stomach: atonic, reddened mucosa
intestine: reddened mucosa
lung: slight emphysema
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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