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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1989
Report date:
1989
Reference Type:
publication
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: American Society for Testing and Materials (ASTM), Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals, Annual Book of ASTM Standards, Designation E 981-84
Principles of method if other than guideline:
Determination of sensory irritation potency by oronasal exposure, key parameter: RD50
(RD50 = the exposure concentration resulting in a 50-% decrease in the respiratory rate).
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
respiratory irritation

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropylamine
EC Number:
200-860-9
EC Name:
Isopropylamine
Cas Number:
75-31-0
Molecular formula:
C3H9N
IUPAC Name:
propan-2-amine
Test material form:
liquid
Details on test material:
high-purity liquid

Test animals

Species:
mouse
Strain:
other: OF1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA Credo, Domaine des Onciens, Saint-Germain sur l'Arbresle, France
- Age at study initiation:
- Weight at study initiation: 20 - 25 g
- Fasting period before study: unfasted
- Housing: in groups of 10
- Diet., water: ad libitum
- Acclimation period: 7 d

controlled ENVIRONMENTAL CONDITIONS (no detailed information given)


Administration / exposure

Route of administration:
inhalation
Vehicle:
unchanged (no vehicle)
Details on exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION (see details below)
- Exposure apparatus: 200 L inhalation chamber
- Method of holding animals in test chamber: Mice were restrained in a body plethysmographs with nose-only exposure.
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Temperature, humidity, pressure in air chamber:
- Air flow rate:
- Air change rate:
- Method of particle size determination:
- Treatment of exhaust air:


TEST ATMOSPHERE
- Brief description of analytical method used: HPLC ( sampling by silica gel in glass tubes; after derivatisation resulting m-Toluene derivatives were
analysed by reversed-phase chromatography with UV detection)
- Samples taken from breathing zone: yes
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Exposure period: 60 min
Frequency of treatment:
1x, 15 min
Post exposure period:
Recovery period: 30 min
Doses / concentrations
Remarks:
Doses / Concentrations:
Several concentrations measured from 69 - 197 ppm
Basis:
analytical conc.
No. of animals per sex per dose:
6 per test concentration
Control animals:
other: internal control = each test animal before exposure
Details on study design:
Observation period: 60 min exposure, 30 min recovery, before, during and after exposure respiratory rate was determined

Results and discussion

Any other information on results incl. tables

The RD50 value for isopropylamine was 157 ml/m3 (ppm) which corresponds  
to approx. 0.39 mg/L. 

Note: Calculation based on MW = 59 and molar volume of 24 L (20 °C): 
1 ml/m3 = 2.46 mg/m3
---------------------

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test substance produced sensory upper airway irritation, like related amines