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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Read-across
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyldimethylamine
EC Number:
203-680-9
EC Name:
3-aminopropyldimethylamine
Cas Number:
109-55-7
Molecular formula:
C5H14N2
IUPAC Name:
N,N-Dimethyl-1,3-diaminopropane
Details on test material:
- Name of test material (as cited in study report): N,N-dimethylpropane-1,3-diamine
- Molecular formula (if other than submission substance): C5H14N2
- Molecular weight (if other than submission substance): 102.1781
- Smiles notation (if other than submission substance): CN(C)CCCN
- InChl (if other than submission substance): InChI=1/C5H14N2/c1-7(2)5-3-4-6/h3-6H2,1-2H3
- Structural formula attached as image file (if other than submission substance): see Fig.2
- Substance type: organic
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 255 ± 7 g, female: 183 ± 7 g
- Housing: groups of five per cage
- Diet: KLIBA rat/mouse laboratory diet ad libitum
- Water: ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
4.31 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before the beginning of the test, after 7 days and at the end of the observation period.
- Frequency of observations: several times during exposure and at least once on each workday in the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test in accordance with tables of the BASF Computer Center.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.31 mg/L air
Exp. duration:
4 h
Remarks on result:
other: no mortality occured
Sex:
male/female
Dose descriptor:
LC0
Effect level:
4.31 mg/L air
Exp. duration:
4 h
Remarks on result:
other: no mortality occured
Mortality:
No mortality occured.
Clinical signs:
other: During exposure: animals showed immediately escape attempts, eyelid closure, accelerated respiration and after 15 min restlessness. After 2 h irregular respiration and closed eyelids were noted. After exposure and during observation period: up to 24 acce
Body weight:
The body weight gain of the male rats in the test group, compared with a historical. control collective, was not affected by the substance over the total observation period.
The body weight gain of the female rats in the test group, compared with a historical control collective, was slightly retarded in the second week of the observation period.
Gross pathology:
No pathologic findings noted.

Any other information on results incl. tables

Body weight:

 Mean body weight (in g)   male        female     
 day 0  day 7  day 14  day 0  day 7  day 14
Test group  255  280  319  183  195  207
 Historical control group  248  286  318  177  196  211

The animals exhibited distinct eye irritation at the day of exposure which repressed during the recovery period (corneal stipplings, fundus not visible). There is indication that the test substance causes local irritation to exposed tissues, including respiratory tract.

Although the limit concentration of 5 mg/L was not fully met, the test is judged sufficient to characterize the acute inhalation toxicity of the substance as virtually nontoxic.

Applicant's summary and conclusion