Registration Dossier
Registration Dossier
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: 220-816-2 | CAS number: 2906-12-9
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:
- other: GLP, OECD 401Guideline, E.C. 92/69/EEC B1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : relative humidity sometimes out of the specified range
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-isopropoxypropylamine
- EC Number:
- 220-816-2
- EC Name:
- 3-isopropoxypropylamine
- Cas Number:
- 2906-12-9
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 3-(propan-2-yloxy)propan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): 3-isopropoxypropylamine
- Physical state: liquid
- Analytical purity: 99.78%
- Purity test date: 1997-08-07
- Lot/batch No.: 9708P0073
- Expiration date of the lot/batch: December 1998
- Stability under test conditions: no data
- Storage condition of test material: in dark and at room temperature
- Other: origin: Usine de Maurienne La Chambre
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ICO: OFA-SD (IOPS Caw)
- Age at study initiation: approx 6 weeks old
- Weight at study initiation: 187+/-4g (males) and 140+/-6g (females)
- Fasting period before study: approx 18hours before dosing, but free access to water
- Housing: ( rats of the same sex per cage (48x27x20cm in polycarbonate)
- Diet (e.g. ad libitum): ad libitum A 04 C pelleted diet (U.A.R. 91360 Villemoisson sur Orge, France), except duting fasting
- Water (e.g. ad libitum): ad libitum drinking water filtered by FG Millipore membrane (0.22µ)
- Acclimation period: at least 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approx 12cycles
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500, 1000 and 2000mg/kg
- Amount of vehicle (if gavage): gavage 10mL/kg
- Justification for choice of vehicle:solubility
- Lot/batch no. (if required): no data
- Purity: no data - Doses:
- 50, 1000, 2000mg/kg
- No. of animals per sex per dose:
- 2000mg/kg: 5males and 5females
1000mg/kg: 5females
500mg/kg: 5females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed frequently after administration and then once daily, and weighted on days 1, 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- LD50 value calculated according to Probit analysis (Weber 1972 and Bliss 1938).
The confidence interval limits are calculated according to Fieller's method (1944)
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 909 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 417 - 1 755
- Mortality:
- 2000mg/kg: all animals died on day 1
1000mg/kg: 2/5females died on day1
500mg/kg: 1/5female died on day 2 - Clinical signs:
- other: 2000mg/kg: hypoacticity, sedation, piloerection, tremors, lateral recumbency, dyspnea 1000mg/kg: sedation, tonico-clonical convulsions, lateral recumbency prior to death. hypoactivity, dyspnea, piloerection for survivors 500mg/kg: sedation, piloerection
- Gross pathology:
- The stomach of the animals given 2000mg/kg had a reddish appearance
No apprent abnormalities were observed in the animals given 1000 or 500mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 of 3-isopropoxypropylamne is 909mg/kg (417-1755mg/kg) in female rats with 95% confidence interval limits.
- Executive summary:
The Acute oral toxicity of 3-isopropoxypropylamine was evaluated in male and female rats according to OECD N°401 guideline (Acute Toxic Standard Method) (Manciaux, 1988). All animals died on day 1 after administration of 2000 mg/kg. They showed hypoactivity, sedation, piloerection, tremors, lateral recumbency and dyspnoea prior to death. After administration of 1000 mg/kg, 2/5 rats showed sedation, tonico-clonical convulsions and lateral recumbency prior to death on day 1. Theses clinical signs were less severe in surviving animals. At 500mg/kg, 1/5 animal showed sedation, piloerection and lateral recumbency and then died on day 2. The oral LD50 of 3-isopropoxypropylamine was 909mg/kg (417-1755mg/kg) in female rats with 95% confidence interval limits.
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.
