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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (BASF study).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981 version of guideline
Deviations:
no
GLP compliance:
no
Test type:
standard acute method

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): Pluriol Q
- Physical state: aqueous solution
- Analytical purity: not reported
- Expiration date of the lot/batch: March 1984

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
- Age at study initiation: 12 weeks
- Weight at study initiation: males: 171 g, females: 177 g (mean)
- Fasting period before study: 16 hours
- Housing: 5/cage
- Diet: fasting period before application
- Water: ad libitum
- Acclimation period: 1 week


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50, 38.3, 26.1 %
- Purity: aqua dest.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2610, 3830, 5000 mg/kg bw
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 observations and weighing: clinical signs: several times on application day, at least once daily otherwise; moribund and dead animals: at least once daily; body weight: initially and on day 4, 7, and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
According to Finney DJ, "Probit analysis", Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 890 mg/kg bw

Any other information on results incl. tables

Clinical signs:

Males:

Symptom  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Dyspnea  15 min - 1 h  30 min - 5 h  1 h - 4 h
 Apathy  15 min - 1 h  30 min - 5 h  
 Aberrant body position  1 h  1 h  
Staggering  30 min - 1 h  30 min - 1 h  
 Tremble  30 min - 1 h  1 h  
 Twitch  1 h    
 Spastic gait  30 min  30 min - 1 d  
 Scrubby fur  30 min - 1 h  1 h  
 Diarrhea  30 min - 1 h  1 h - 1 d  
 Exophthalmus  30 min  1 h  
 Bad general condition  30 min - 1 h  30 min - 5 h  

Females:

Symptoms  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Dyspnea  15 min - 30 min  30 min  30 min - 1 d
Apathy  15 min - 30 min  30 min  30 min - 1 d
 Aberrant body position  30 min  30 min  
 Staggering    30 min  30 min - 5 h
 Atony    30 min  
 Absent pain reflex    30 min  
 Narcosis-like condition    30 min  
 Tremble  30 min  30 min  30 min - 1 h
 Twitch  30 min  30 min  
 Spastic gait    30 min  30 min - 1 d
 Scrubby fur 30 min   30 min  1 h - 1 d
 Diarrhea  30 min  30 min  30 min - 1 d
 Exsiccosis    30 min  
 Exophthalmus  30 min    30 min - 1 h
 Bloody exsudate from nose      4 h - 5 h
 Bad general condition  30 min  30 min  30 min - 1 d

Mortality:

Males:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 1 h  3/5  1/5  0/5
 1 d  5/5  3/5  0/5
 2 d  5/5  3/5  0/5
 7 d  5/5  3/5  0/5
 14 d  5/5  3/5  0/5

Females:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 1 h  5/5  5/5  0/5
 1 d  5/5  5/5  1/5
 2 d  5/5  5/5  1/5
 7 d  5/5  5/5  1/5
 14 d  5/5  5/5  1/5

Mean body weight (g):

Males:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Initially  180  167  165
 4 d  -  209  180
 7 d  -  230  221
 13 d  -  267  266

Females:

 Time  5000 mg/kg  3830 mg/kg  2610 mg/kg
 Initially  171  178  182
 4 d  -  -  205
 7 d  -  -  217
 14 d  -  -  233

Pathology:

Deceased animals:

Profound diarrhea.

Sacrificed animals:

Organs without clinical findings.

Applicant's summary and conclusion