Amines, polyethylenepoly-, triethylenetetramine fraction

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA FR Vol.50, No. 188, September 27, 1985

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

purity and storage conditions are not reported

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, polyethylenepoly-, triethylenetetramine fraction

EC Number:

292-588-2

EC Name:

Amines, polyethylenepoly-, triethylenetetramine fraction

Cas Number:

90640-67-8

Molecular formula:

C6H18N4, C8H20N4

IUPAC Name:

Amines, polyethylenepoly-, triethylenetetramine fraction

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc.,Wilmington, Massachusetts
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 175-224 g
- Fasting period before study: yes
- Housing:individually in stainless steel 1/2'' wire mesh cages, sized in accordance with the "Guide for the Care and Use of Laboratory Animals'' of the Institute of Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Harlan Teklad Lab Blox, ad libitum
- Water (e.g. ad libitum):no data
- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

800, 1250, 1600 and 2000 mg/kg bw

No. of animals per sex per dose:

10 (5♂ and 5♀)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pharmacological and toxicological effects: at 1, 4 and 24 hours after dosing and once a day through 14 days; viability: once a day; body weight: d0, d7 and d14 or were found dead
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The method of Litchfield and Wilcoxon via Innovative programing Associates,LABCAT Module Version 4.22.

Results and discussion

Preliminary study:

Dose-range -finding: 3 groups of 2 rats (1♂ and 1♀ per group) fasted and administrated test article at the dose levels: 500, 2500 and 5000mg/kg bw, orally by gavage. 0/2 animal died at the 500mg/kg bw dose level; 2/2 animals died at both the 2500 and 5000mg/kg bw dose levels.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 861.9 mg/kg bw

Based on:

test mat.

95% CL:

1 383.5 - 2 505.7

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 591.4 mg/kg bw

Based on:

test mat.

95% CL:

1 283.5 - 1 973.3

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 716.2 mg/kg bw

Based on:

test mat.

95% CL:

1 446.5 - 2 036.1

Mortality:

0/10 animals died at both the 800 and the 1250mg/kg bw dose levels
5/10 animals died at the 1600 mg/kg bw dose level
7/10 animals died at the 2000 mg/kg bw dose level

Clinical signs:

other: decreased activity, abnormal gait, abnormal stance, prostration, diarrhea, lacrimation and dyspnea

Gross pathology:

Necropsy of the animals dying on study revealed fluid-filled and distended intestines and stomachs and discolored lungs and intestines. No visible lesions were observed in any animal at terminal necropsy .

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008

Conclusions:

Based on the results from the Acute Exposure Oral Toxicity in rats, the acute oral LD50 for males, females and combined sexes was determined to be 1861.9 (1383.5 - 2505.7) mg/kg bw, 1591.4 (1283.5 - 1973.3) mg/kg bw and 1716.2 (1446.5 - 2036.1) mg/kg bw, respectively.

Executive summary:

An acute oral toxicity study with TETA was carried out in Sprague Dawley rats. Groups of 5 rats per sex were treated per gavage at 800, 1250, 1600 or 2000 mg/kg bw and were observed for 14 days thereafter. Mortality was 0, 0, 50 and 70%, respectively. The acute oral LD50 for males, females and combined sexes was determined to be 1861.9 (1383.5 - 2505.7) mg/kg bw, 1591.4 (1283.5 - 1973.3) mg/kg bw and 1716.2 (1446.5 - 2036.1) mg/kg bw, respectively.