Octadecane-1,12-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The experiments were carried out from January to February 1981.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, near guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octadecane-1,12-diol

EC Number:

220-342-6

EC Name:

Octadecane-1,12-diol

Cas Number:

2726-73-0

Molecular formula:

C18H38O2

IUPAC Name:

octadecane-1,12-diol

Details on test material:

- Name of test material (as cited in study report): Loxanol
- Loxanol is a mixture of 12-hydroxystearoylalcohol and monostearoylalcohol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 16 hours
- Housing: Makrolon 3 cages, 5 animals per cage, soft wood granulate bedding
- Diet: Altromin-Haltungsdiät 1324, Altromin GmbH, 4937 Lage (D), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% aqueous suspension

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5 and 25 % (g/v)
- Amount of vehicle: 20 mL/kg

Doses:

1000 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms and mortality several times on the day of application, afterwards 2 x daily. The animals were weighed on the day of the application (with an empty stomach), 48 hours, 7 days after 14 days after the application.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the 20 animals died during the period of 14 days after application.

Clinical signs:

other: No symptoms of intoxication were observed during a period of 14 days after the application.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of the test substance after oral application was found to be greater than 5000 mg/kg bw in male rats.

Executive summary:

The acute oral toxicity test was conducted similar to OECD 401 by oral gavage. 10 male Wistar rats per dose were exposed to a single dose of 1000 or 5000 mg/kg test substance suspended in 2 % aqueous CMC-suspension. The rats were observed for 14 days. None of the 20 animals died during the period of 14 days after application and no symptoms of intoxication were observed. Under the conditions of this study the median lethal dose (LD50) of the test substance after oral application was found to be greater than 5000 mg/kg bw in male rats.