Reaction products of enzymatic esterification of linolenic acid and 1,2-octanediol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

This deviation was not considered to have compromised the validity or integrity of the study.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol

EC Number:

944-490-2

Molecular formula:

unknown

IUPAC Name:

1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol

Test material form:

liquid

Specific details on test material used for the study:

Pale yellow oily liquid.
Density of 0.95.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

6 nulliparous and non pregnant female rats, aged 8 or 9 weeks at the time of dosing.
Acclimatation period of at least 5 days before dosing: animals were observed once a day for clinical signs and mortality.
Temperature of 22°C, hydrometry between 30 and 70%, at least 10 full air changes/h, 12h/12h light/dark cycle (7 a.m. to 7 p.m.). Food and drink given ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Administration by gavage, using a plastic syringe fitted with an esophageal canula.

Doses:

2000 mg/kg as starting dose.
The starting dose-level was selected considering the chemical structure of the test item (ester of unsaturated fatty acid and alcohol in C8) which is not expected to induce mortality at 2000 mg/kg when administered by the oral route.

No. of animals per sex per dose:

3 animals/step (maximum of 2 steps per dose-level)

Control animals:

not specified

Details on study design:

The test item was tested using a stepwise procedure with a maximum of 2 steps per dose-level. The starting dose was fixed at 2000 mg/kg (two steps) with a dosage-volume of 2.1 mL/kg which corresponded to the liquid form of the test item.
Administration of treatment to rats followed by 14 or 15 days of observation. Body weights were measured on days 1, 3, 8 and 15 and macroscopic examination was performed for all sacrificed animals on day 15. Clinical signs were assessed 30 min, 1h and 3h after dosing and then, once daily for 14 days. Mortality and morbidity checks were carried out twice on day 1 then once daily.

Statistics:

not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg, no death were observed at either step throughout the period of observation.

Clinical signs:

other: At 2000 mg/kg, no clinical signs were observed throughout the period of observation.

Gross pathology:

No anomaly was detected at necropsy.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Within the experimental conditions of the study, Diolénique C8, can be assigned to Category 5 or the Unclassified Category of the GHS. Since no mortality was encountered, the LD50 is estimated to be higher than 2500 mg/kg.

Executive summary:

In an OECD Guideline N° 423 Acute Oral Toxicity test, Diolénique C8 can be assigned to Category 5 or the Unclassified Category of the GHS. Since no mortality was encountered, the LD50 is estimated to be higher than 2500 mg/kg.