Fatty acids, C18-unsaturated, 2-hexyldecyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

29 Aug - 21 Sep 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

yes

Remarks:

analytical purity of the test substance was not reported

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-octyldodecyl myristate

EC Number:

245-205-8

EC Name:

2-octyldodecyl myristate

Cas Number:

22766-83-2

Molecular formula:

C34H68O2

IUPAC Name:

2-octyldodecyl myristate

Test animals

Species:

rat

Strain:

other: OFA.Sprague-Dawley (IOPS Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo, L'Arbresle, France
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 145.0 g (mean, females) and 164.4 g (mean, males)
- Fasting period before study: 18 h
- Housing: animals were caged in groups of 5/sex in type FI polycarbonate cages (365 mm x 225 mm x 180 mm). Bedding was changed weekly.
- Diet: complete pelleted rat-mouse maintenance diet U.A.R. formule A.04 CR, U.A.R. (Epinay-S/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 10 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 35 mL/kg bw

Doses:

29.75 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of mortality and signs of toxicity were made 15 minutes and 1, 2 and 4 hours after administration, and daily thereafter; animals were weighed on Day -1, Day 1 prior to dosing and on Day 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 29 750 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

No substance-related findings were noted during the necropsy and histopathological examination.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008