Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-09-27 to 2016-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted December 17, 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine

EC Number:

271-547-2

EC Name:

Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine

Cas Number:

68585-02-4

Molecular formula:

C28H63N5O4

IUPAC Name:

acetic acid;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;octadecanoic acid

Test material form:

solid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 168 - 183 g
- Fasting period before study: yes, feeding was discontinued approx. 16 hours before administration
- Housing: MAKROLON cages (type III plus) groups of 3 animals
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 ad libitum
- Water (e.g. ad libitum): from municipal source, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle

First dosing October 11, 2016
Termination of the in-life phase October 26, 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw - limit test

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Initial test three females at 2000 mg/kg bw, as no animal died further 3 females were exposed.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily animals were observed, weighting weekly
- Necropsy of survivors performed: yes

Statistics:

not applicable - limit test

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No animal died

Clinical signs:

Slightly reduced motility, slight ataxia, slightly reduced muscle tone, and pilo-erection in all 6 of 6 animals and slight dyspnoea in 2 of 6 animals 5 to 30 minutes after administration.

Body weight:

All animals gained the expected body weight.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 > 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study according to OECD guideline 423 and EC method B.1 tis, a total of 6 female CD rats were given a single oral dose of 2000 mg/kg bw Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine and observed for 14 days.

Oral LD₅₀      Females = > 2000 mg/kg bw

No animal died prematurely. The following clinical signs were observed: slightly reduced motility, slight ataxia, slightly reduced muscle tone, and pilo-erection in all 6 of 6 animals and slight dyspnoea in 2 of 6 animals 5 to 30 minutes after administration. All animals gained theexpected body weight. No pathological changes were observed at necropsy.