A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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: 200 - 300 g; +-20% of the mean weight
- 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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Single application of 2.2 ml/kg bw (density 0.908 g/mL) to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semiocclusive dressing for 24 hours, afterwards removal of the dressing. Rinsing of the application site with warm water.
Clipping of the fur: at least 15 hours before the beginning of the study.

Duration of exposure:

single application for 24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Observation period: 14 days
Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study period.
Signs and symptoms: Recording several times on the day of administration, at least once each working day for the individual animals.
Scoring of skin findings: Individual readings 30 - 60 min after removal of the semiocclusive dressing, weekly thereafter and at the and of the study period.
General observations and mortality: A check was made each working day and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
Pathology: Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before death 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:

> 2 000 mg/kg bw

Mortality:

No mortalities observed.

Clinical signs:

No abnormalities observed.

Body weight:

Mean body weights of the male animals: before application 281 g, after 6 days 299 g, after 13 days 331 g
Mean body weights of the female animals: before application 219 g, after 6 days 219 g, after 13 days 222 g

Gross pathology:

No pathologic findings noted.

Other findings:

No local abnormalities observed.

Any other information on results incl. tables

There was no death and no systemic or local sign of reaction to the treatment