Isooctadecan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

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)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecan-1-ol

EC Number:

248-470-8

EC Name:

Isooctadecan-1-ol

Cas Number:

27458-93-1

Molecular formula:

C18H38O

IUPAC Name:

2-methylheptadecan-1-ol

Constituent 2

Reference substance name:

Iso Stearyl alcohol

IUPAC Name:

Iso Stearyl alcohol

Test material form:

other: Liquid

Details on test material:

Colourless liquid (Prisorine 3515 Iso Stearyl Alcohol No 82350)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Asingle dose of 2 g/kg (bw) administered undiluted.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed prior to administration of the test substance and then on day 3,4,7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All animals were sacrificed on day 14 and an examination of the main vital organs was conducted

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were reported during the study period.

Gross pathology:

No evidence of toxicity and no lesions noted in any of the organs that were examined.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to current OECD guideline and in compliance with GLP.

Executive summary:

In an acute oral toxicity study conducted in accordance with OECD 401, a single oral administration of 2 g/kg (bw) Prisorine 3515 Iso Stearyl Aclohol was administered to 5 male and 5 female rats. No treatment related effects or mortality was reported under the conditions of this study. The LD50 is greater than 2 g/kg (bw) in the rat.