N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 4, 1995 to February 6, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine

EC Number:

930-859-5

Molecular formula:

C23-25H49-53NO3

IUPAC Name:

N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine

Test material form:

solid

Remarks:

Amber solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: August 1999

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

OTHER SPECIFICS: Amber solid

Test animals

Species:

rat

Strain:

other: Crl:CD (BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Males: approximately 10 weeks; Females: approximately 11 weeks
- Weight at study initiation: Males: 290 to 363 g; Females: 230 to 250 g
- Fasting period before study: After recording animal body weights, all food was removed during the evening immediately prior to the day of administration of the test material. Food was withheld until completion of dosing the following morning.
- Housing: Single housed during the study period in suspended stainless steel and wire mesh caging with absorbent paper below cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 23 d

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 to 76
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12/12 by automatic timer

IN-LIFE DATES: From: January 5, 1995 To: January 19, 1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The undiluted test material was warmed until it was doseable. The temperature of the water bath was 49 °C. The test material was administered as a single oral intubation via syringe and a stainless steel, stright, ball tipped feeding needle.

Doses:

2000 mg/kg fasted body weight

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: The animals were examined for viability twice during during the week and once dialy during weekends. Body weights were recorded on the day prior to dosing (pretest), the day of dosing (Day 0), on Day 7, Day 14, and at death for animals which succumbed prior to study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: Clincila observations were made as to the nature, onset, severity, and duration of toxicoloigical signs at 1, 2, 4, and 6 h after dosing, and once per day thereafter for a total of 14 d. The time of death was recorded, as precisely as possible, for animals which succumbed prior to study termination.

Statistics:

Statistical analysis included means and standard deviations of body weight and body weight change by group and sex.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Two female animals died prior to study termination. On Days 0 and/or 1, one of the animals was observed with oral and ocular discharge, dyspnea, wet rales, and hypoactivity. The other animal was observed with abdominal/ anogenital staining and soft stool. Both animals were found dead on Day 2.

Clinical signs:

other: Clinical signs of the 8 animals wich survived to study termination included oral or nasal discharge, decreased food consumption, emaciated, staining of the skin/ fur, and /or stool abnormalities. These signs were observed primarily from Day 2 to Day 7, b

Gross pathology:

All animals whcih survived to study termination were without gross abnormalities at postmortem examination.

Gross postmortem observations of the 2 females that succumbed included doscoloured liver and/or lungs, consolidated lungs, this/ discoloured stomach lining, roughened glandular portion of the stomach, distended/ discoloured small intestine, and/or staining of the skin/ fur.

Any other information on results incl. tables

Please see the attached tables:

Table 1: Individual inlife observations

Table 2: Individual body weight

Table 3: Individual body weight changes

Table 4: Individual gross postmortem observations

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test material was assessed in accordance with OECD Guideline 401. Overt signs of toxicity were apparent at a dose level of 2000 mg/kg in all animals as indicated by adverse clinical signs and/or body weight gain suppression, as well as mortality in 2 of the 10 animals. All surviving animals appeared to recover by Day 12. Based on the results of this study, the test material elicited evidence of toxicity at a dose of 2000 mg/kg, but the LD50 is > 2000 mg/kg. As such, the test material does not meet the criteria for classification.