[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Oct - 12 Nov 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Docosanoic acid

EC Number:

204-010-8

EC Name:

Docosanoic acid

Cas Number:

112-85-6

Molecular formula:

C22H44O2

IUPAC Name:

docosanoic acid

Details on test material:

The test substance provided by Nippon Oil & Fats (NOF) Corporation was used. The test substance was stored at room temperature until use.

Specific details on test material used for the study:

The test substance was prepared into a suspension of 20% (w / v) using corn oil (Nacalai Tesque) on the day of administration and used as a sample to be administered. It was confirmed that the test substance in the administered sample was uniform and stable, and that the administered sample used in this test contained a predetermined amount of the test substance.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: female: ~90 g; male: ~100 g
- Fasting period before study: 18 hours
- Housing: metal wire floor cage
- Diet (ad libitum): solid food (CE-2, Clea Japan)
- Water (ad libitum): tap water
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 - 24.3
- Humidity (%): 54 - 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Samples were prepared and administered in suspension
- Amount of vehicle (if gavage): 20 % (w/v)
- Justification for choice of vehicle: test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
The dose was calculated based on the body weight measured immediately before administration, and forced using a rat gastric tube.

Doses:

2000 mg/kg bw (based on results of preliminary study)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations: once daily and weighing: on days 0, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

In a preliminary test, three concentrations (20, 200, 2000 mg/kg bw) were tested in male rats and the effect was observed for 8 days. Soft feces excretion was observed but no death.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred of either males or females in the treated groups.

Clinical signs:

other: No effects on general condition were found.

Gross pathology:

Nothing abnormal was detected in gross pathology.

Other findings:

As a change in general condition, excretion of loose stool was observed in 4 males and 4 females in the 2000 mg / kg group from 30 minutes to 6 hours after administration. However, in the solvent control group to which corn oil was administered, similar changes were observed in all males and 4 females within the same time period. Therefore, it was judged that this change was due to solvent ingestion and did not suggest the toxicity of the test substance.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met