Registration Dossier

Administrative data

Description of key information

The oral LD50 of > 2000 mg/kg bw was determined for Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine in an OECD 423 guideline studie.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted December 17, 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals 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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Guideline study with GLP

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

Justification for classification or non-classification

Based on relevant, reliable and adequate data, Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine does not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute oral toxicity.