Registration Dossier

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:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
EC Number:
406-640-0
EC Name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
Cas Number:
136920-07-5
Molecular formula:
C58H114N4O6 - C154H308N6O4
IUPAC Name:
Reaction mass of 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C12-C18)alkylacetamide and {[2-(Carboxymethyl-di(C12-C18)alkylcarbamoylmethyl-amino)-ethyl]-di(C12-C18)alkylcarbamoylmethyl-amino}-acetic acid
Constituent 2
Reference substance name:
Keroflux ES 3241
IUPAC Name:
Keroflux ES 3241
Details on test material:
- Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Storage condition of test material: Refrigerator
- Date of manufacturing: 1990-10-10

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, D
- Age at study initiation: Young adult animals
- Weight at study initiation: 187 (m); 179 (f); no more than +/-10% of the mean weight
- Fasting period before study: at least 16 h
- Housing: single in stainless steel wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 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:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 44 g/100 mL
- Justification for choice of vehicle: Poor solubility of the test substance in aqua dest.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
2200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period was 14 days. Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study. Recording of signs and symptoms several times on the day of administration, at least once each working day for the individual animals.
A check for general observations and mortality was made twice each working day and once on saturdays, sundays and public holidays. Necropsy was done at the last day of the observation period. Withdrawal of food at least 6 h before deaths with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.
Statistics:
-

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Mortality:
No mortality
Clinical signs:
Male animals: dyspnoe, staggering, piloerection, impaired general state and additionally in one male animal apathy and poor general state. The male animals were normal at about 1 - 6 days after application.
Female animals: piloerection on the day of application.
Body weight:
Male animals: before application 187 g, after 7 days 261 g, after 13 days 291 g.
Female animales: before application 179 g, after 7 days 206 g, after 13 days 218 g.
Gross pathology:
No abnormalities observed.

Any other information on results incl. tables

The concentration analytically found corresponds to approximately 93% of the exspected value.

Applicant's summary and conclusion