3,3'-oxybis(ethyleneoxy)bis(propylamine)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

EC Number:

224-207-2

EC Name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

Cas Number:

4246-51-9

Molecular formula:

C10H24N2O3

IUPAC Name:

3,3'-[oxybis(ethane-2,1-diyloxy)]dipropan-1-amine

Specific details on test material used for the study:

- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Expiration date of the lot/batch: July 1985

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, FRG
- Weight at study initiation: mean males: 182 g; mean females: 171 g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

(aqua dest.)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 14.7%, 21.5%, 31.6%
- Justification for choice of vehicle: aqueous preparation corresponds to physiological medium

DOSE VOLUME APPLIED: 10 ml/kg

Doses:

1470, 2150, 3160 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: check for mortality twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 7 and 12
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 160 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 850 mg/kg bw

Based on:

test mat.

Remarks on result:

other: value from interpolation

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 3 160 mg/kg bw

Based on:

test mat.

Mortality:

The highest applied dosage caused mortality (80%, 40% mortality for male and female rats, respectively) See table1 ("Any other information on results incl. tabeles")

Clinical signs:

other: Clinical signs included dyspnoea, rattling breath, apathy, agitation, abnormal position, staggering, tremble, tremor, spastic gait, piloerection, poor general state

Gross pathology:

Animals that died: general congestive hyperemia; stomach: bloody gastritis in glandular stomach; intestine: atonic, reddened diarrheal content.
Sacrificed animals: No abnormalities.

Any other information on results incl. tables

Tab. 1: Mortality:

Dose (mg/kg)		3160	2150	1470
Males
Dead animals/total animals after	1 h	0/5	0/5	0/5
	1 d	4/5	0/5	0/5
	2 d	4/5	0/5	0/5
	7 d	4/5	0/5	0/5
	14 d	4/5	0/5	0/5
Females
Dead animals/total animals after	1 h	0/5	0/5	0/5
	1 d	2/5	0/5	0/5
	2 d	2/5	0/5	0/5
	7 d	2/5	0/5	0/5
	14 d	2/5	0/5	0/5

 

Tab. 2: Mean body weights (g):

	Dose (mg/kg)	Weight day
		0	2	7	12
Males	3160	179	186	213	253
	2150	180	204	238	263
	1470	188	219	251	278
Females	3160	171	169	189	201
	2150	167	186	199	211
	1470	176	196	212	225

 

 

Tab. 3: Symptoms (cageside observations):

Dose (mg/kg)	3160	2150	1470
Males
Dyspnoea	1H-2D
Apathy	1H-4H
Agitation	1D-2D
Staggering	1H-2D
Piloerection	1H-6D
Poor general state	1H-2D
Females
Dyspnoea	1H-2D
Rattling breath	4H-2D
Apathy	1H-2D
Abnormal position	4H
Staggering	1H-2D
Tremble	4H
Tremor	4H
Spastic gait	2D
Piloerection	4H-6D
Poor general state	1H-2D

H: Hour; D: Day

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The aute oral toxicity study revealed a LD50 of 2850 mg/kg bw for male rats and a LD50 of 3160 mg/kg bw for female rats as well as males/females.

Executive summary:

In an acute toxicity study similar to OECD guideline 401 (non-GLP, reliability 2) 5 rats/sex were exposed to 1470, 2150, 3160 mg/kg bw of the test substance per gavage. No mortality was observed the low- and mid-dose group. The dosage of 3160 mg/kg bw caused 60% mortality in the rats (80% mortality for males, 40% mortality for females). Therefore, the LD50 for male and female rats was 3160 mg/kg bw (LD50males = 2850 mg/kg bw, LD50females = 3160 mg/kg bw). Clinical observations revealed dyspnoea, rattling breath, apathy, agitation, abnormal position, staggering, tremble, tremor, spastic gait, piloerection, poor general state. Animals wich died after oral exposure had general congestive hyperemia as well as pathological findings in the stomach and intestine (bloody gastritis in glandular stomach, atonic, reddened diarrheal content). All other sacrifieced anilmals did not show abnormalities and gained bodyweight during the study.