Reaction mass of octadecyl heptanoate and octadecyl octanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. The analytical purity of the test substance was not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

yes

Remarks:

the analytical purity of the test substance is not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

octadecyl heptanoate; octadecyl octanoate

EC Number:

915-334-0

Molecular formula:

C25H50O2 C26H52O2

IUPAC Name:

octadecyl heptanoate; octadecyl octanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: white, waxy substance
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Animals Ltd.
- Weight at study initiation: 122 - 123 g (males), 120 - 123 g ( females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 5/sex/cage
- Diet: Spratts No. 2 autoclaved laboratory small animal diet, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): approximately 50

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 16 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg bw (equivalent to 15.4 g/kg bw based on a density of 0.961 g/cm³)

Doses:

16 mL/kg bw (equivalent to 15.4 g/kg bw based on a density of 0.961 g/cm³)

No. of animals per sex per dose:

5

Control animals:

yes

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 daily; animals were weighed prior to dosing and on Day 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 15.4 g/kg bw based on a density of 0.961 g/cm³

Mortality:

No mortality occurred during the study period in the treatment or control group.

Clinical signs:

other: No clinical signs of toxicity were observed in the treatment or control group up to the end of the 14-day observation period.

Gross pathology:

No substance-related findings were noted in the treatment or control group during necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified