Octadecan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecan-1-ol

EC Number:

204-017-6

EC Name:

Octadecan-1-ol

Cas Number:

112-92-5

Molecular formula:

CH3(CH2)17OH

IUPAC Name:

octadecan-1-ol

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River (UK) Ltd., Margate, kent, UK.

- Age at study initiation: 5-8 weeks

- Weight at study initiation: 137-151g males, 124-135g females

- Fasting period before study: overnight

- Housing: The animals were housed in groupd of five by sex in solid floor polypropylene cages furnished with woodflakes.

- Diet: Rat and Mouse Expanded Diet No.1, ad libitum, Special Diets Services Ltd., Witham, Essex, UK

- Water: mains drinking water, ad libitum

- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 19-22C

- Humidity (%): 39-60

- Air changes (per hr): ca. 15

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: arachis oil

Details on oral exposure:

VEHICLE

- Concentration in vehicle: 10 mg/ml


MAXIMUM DOSE VOLUME APPLIED: 200 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5M, 5F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and for the remainder of the observation period. Individual bodyweights were recorded prior to dosing on Day 0 and on days 7 and 14.

- Necropsy of survivors performed: yes, the animals were killed by cervical dislocation

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The gross pathological examination consisted of external examination and opening of abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded.

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No other findings reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of >2000 mg/kg was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.

Executive summary:

In an acute oral toxicity study, 2000 mg/kg of test material dissolved in arachis oil was administered to 5 male and 5 female rats. Body weight changes and clinical signs of toxicity were noted regularly during the 14 -day study period. Necropsy was performed at the end of the study.

There were no deaths during the 14 -day study period. No signs of systemic toxicity were observed. The expected gain in body weight was observed in all animals. No macroscopic abnormalities were observed at necropsy.

An LD 50 value of > 2000 mg/kg bw was reported. The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.