3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Not GLP

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Justification for type of information:

The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The molecular weight, number of hydrogen bond donors, number of hydrogen bond acceptors, water solubility, and partition coefficient values for both substances indicate they will have similar bioavailability in both an aquatic environment and after oral dosing.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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

Test material form:

liquid

Specific details on test material used for the study:

minimum purity 95%

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

Details on oral exposure:

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

Doses:

1470 mg/kg bw, 2150 mg/kg bw, 3160 mg/kg bw at 10mL/kg

No. of animals per sex per dose:

No. of animals per sex per dose: 5 Male and 5 Female animals per dose group.

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 160 mg/kg bw

Based on:

test mat.

Mortality:

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
14d 2/5 0/5 0/5

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.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The Oral LD50 = 3160 mg/kg bw.

Executive summary:

The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.