N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from April 4, 1996 to June 20, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

EC Number:

260-982-3

EC Name:

N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

Cas Number:

57843-53-5

Molecular formula:

C18H36N2O6

IUPAC Name:

N,N,N',N'-tetrakis(2-hydroxypropyl)hexanediamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system: Rat, Hanlbm: WIST (SPF)
Rationale: Recognized by the international guidelines as a recommended test system.
Source: 8RL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Fullinsdorf / Switzerland
Number of animals per group: 5 males, 5 females
Age when treated: males: 8weeks females: 10 weeks
Body weight range when treated: males: 201 - 205 g females: 172 - 182 g
Identification: By unique cage number and corresponding color-coded spots on the tail.
Randomization: Randomly selected at the time of delivery into groups of five.
Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
HUSBANDRY
Room No.: E 16 / RCC
Conditions:
Standard Laboratory Conditions.
Air-conditioned with XO-15 air changes per hour and continuously monitored environment with target ranges for temperatures of 20 ±3 degrees centigrade, and for relative humidity between 40 - 70 % (values above 70% during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation:
Groups of five in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
Diet: Pelleted standard Kliba 343, Batch no. 72/96 rat maintenance diet (Kliba Muhlen AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application). Results of analyses for contaminants are included in the report.
Water: Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

test article preparation:
The test article was placed into a glass beaker on a tared Mettler PM 460 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared. A homogenizer (Ultra-Turrax, Janke & Kunkelr 0-79219 Staufen) was used to ensure homogeneous distribution of the test article in vehicle.
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel, D-79219 Staufen) .
The preparation was made shortly before dosing.
Treatment:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 16 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
Dose/kg body weight: 2000 mg
Application Volume/ kg body weight: 10 ml
Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

test article was administered by single oral gavage to rats, followed by an observation period of 14 days.
observation:
Mortality / Viability: Four times during test day 1 and once daily during days 2 - 15.
Body Weights: On test day 1 (pre-administration), 8 and 15.
Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during day 1 and once daily during days 2 - 15.

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: There were no deaths as a result of treatment with the test article. No adverse effect was observed in the clinical sign, body weight and macroscopic findings.

Mortality:

There were no deaths as a result of treatment with the test article.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The mean lethal dose of test article after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because no mortality occured and the LD50 was found greater than 2000 mg/kg.

Executive summary:

The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight. A weight by volume dilution was prepared with bi-distilled water as vehicle. There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age. No macroscopic findings were observed at necropsy.

Therefore, it is concluded that test article is not subject to classification for acute oral toxicity according to CLP (Regulation EC No. 1272/2008).