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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: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Dissertation: Quadrol, N, N, N', N'-Tetrakis(2-Hydroxypropyl)ethylenediamine: pharmacokinetics and assessment of acute toxicity.
Author:
Dunphy MJ
Year:
1991
Bibliographic source:
Graduate Faculty of the University of Akron
Reference Type:
publication
Title:
Dissertation: Quadrol, N, N, N', N'-Tetrakis(2-Hydroxypropyl)ethylenediamine: pharmacokinetics and assessment of acute toxicity.
Author:
Dunphy MJ
Year:
1991
Bibliographic source:
Dissertation Abstracts International B52/02, 762, Order No. 9119922

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
EC Number:
203-041-4
EC Name:
1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
Cas Number:
102-60-3
Molecular formula:
C14H32N2O4
IUPAC Name:
1-({2-[bis(2-hydroxypropyl)amino]ethyl}(2-hydroxypropyl)amino)propan-2-ol
Details on test material:
- Name of test material (as cited in study report): Quadrol
- Physical state: viscous fluid
- Analytical purity: >90 %
- Impurities (identity and concentrations): no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Zivic Miller Laboratories
- Weight at study initiation: 250-300 g
- Housing: separate
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intravenous
Vehicle:
water
Details on exposure:
- Volume of injection: 1 ml
- Side of application: Caudal vein
Doses:
250, 500 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for clinical observations and mortalities; on days 2, 7 and 14 for blood and urine analysis
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, urine analytes (glucose, bilirubin, ketones, protein, blood and pH), plasma analytes (ethylenediamine, +4PO, urea, LDH, creatinine, total protein, glucose, cholesterol, ALT
Statistics:
Results from dosed rats were compared to controls by a two-tailed t-test.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Mortality:
500 mg/kg bw: 2/10
250 mg/kg bw: 1/10
control: 1/10
There were no immediate deaths following dosing in any group. The animals of the control and 250 mg/kg bw groups died following orbital bleeding. The cause of death appeared to be the ether exposure.
Clinical signs:
Immediately after dosing hyperventilation for typically about 1-2 min, lethargy during the first 1-2 hours post-dose, particularly after the 500 mg/kg bw doses; stool samples usually normal in colour and consistency. Deaths were preceded by bouts of diarrhea and convulsions. All surviving rats were eating, drinking and sleeping normally following 24 hours post-dose.
Other findings:
- Urine analysis: no unusual components, protein, blood, bilirubin, glucose and ketones were negative or trace, the pH was generally in the range of 7-8, which is normal for the SD rat.

- Chlinical chemistry: No test substance-induced variations.

Any other information on results incl. tables

Plasma analytes for acute i.v. dosing:

 Dose [mg/kg bw]  Day  n  B. weight [g]  Ethylenediamine, +4PO [mg/ml]  Glucose [mg/dl]  BUN [mg/dl]  Choles. [mg/dl]  LDH [U/l]  Creat. [mg/dl]  T. prot. [g/dl]  ALT [U/l]
 Control  pre 10  293±12  n.d.  133±13.9  22±1.5  104±12.5 175±24.5   0.64±0.14  7.7±0.44  46±8.0
   2 10  298±15  n.d.  136±13.5  23±1.2  112±13.6 180±21.8  0.64±0.12  7.4±0.39  43±7.3
   7 10  311±19  n.d.  129±14.8  22±1.6  108±13.3  172±36.4  0.67±0.11  7.7±0.46  48±8.1
   14  9  336±16  n.d.  136±13.1  23±1.2  108±14.1  184±27.9  0.65±0.11  7.8±0.43  45±7.7
 250  pre 10  284±11  2.94±0.23  138±14.7  23±1.5  105±16.8  165±21.9  0.64±0.14  7.8±0.48  55±9.7
   2  9  288±12  3.01±0.30  143±16.0  23±1.4  114±16.2  172±21.6  0.65±0.12  7.1±0.67  47±9.6
   7  9  301±17  2.88±0.26  139±13.9  24±1.6  116±13.4  178±26.4  0.66±0.11  7.5±0.46  48±8.6
   14  9  327±18  3.11±0.29  144±18.3  23±1.3  113±14.1  176±32.1  0.65±0.13  7.3±0.54  51±7.7
 500  pre 10  290±14  6.87±0.44  145±13.2  22±1.2  119±15.2  177±19.5  0.63±0.11  7.7±0.44  48±9.1
   2 10  290±17  7.03±0.59  131±10.8  23±1.2  114±17.2  189±20.6  0.64±0.11  7.6±0.57  57±4.6
   7  9  299±19  6.65±0.66  136±14.7  24±1.4  125±16.4  188±21.9  0.66±0.12  7.5±0.46  60±7.6
   14  8  321±14  6.78±0.55  140±14.3  23±1.4  123±14.8  175±22.1  0.65±0.13  7.6±0.34  56±6.7

n.d. none detected

Applicant's summary and conclusion