Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

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 Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

EC Number:

241-924-6

EC Name:

Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

Cas Number:

18016-43-8

Molecular formula:

C38H69N3O – C58H111N3O3

IUPAC Name:

(9Z)-octadec-9-enoic acid; bis(2-aminoethyl)amine

Details on test material:

- Name of test material (as cited in study report): Oleic acid, compound with N-(2- aminoethyl)ethane-1,2-diamine
- Physical state: liquid
- Analytical purity: Reaction product of Oleic acid and N-(2-aminoethyl) ethane-1,2-diamine: elemental analysis yielded 100.4 g/100 g; "Triamide"-content: 5.2 g/100 g (HPLC analysis)
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males approx. 8 weeks, females approx. 12 weeks
- Weight at study initiation: males 235-247 g, females 204-211 g
- Housing: single housing in Makrolon cages, type III, with bedding (H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)) and enrichment (NGM E-022; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm2
- % coverage: 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation; recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals; scoring of skin findings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly and on the last day of observation; mortality at least once each workday.
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. The following test item-related local effects were recorded during the course of the study: o Very slight to severe erythema (grade 1 to 4) o Very slight to moderate edema (grade 1 to

Gross pathology:

The mean body weight of the animals increased throughout the study period within the normal range.