Alcohols, C16-18

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

ALFOL 1618 alcohol,Hayes Consultancy Service Bromley, Kent

Author:

Continental Oil Company.

Year:

1979

Bibliographic source:

Toxicity test summary dated February 8th 1979.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: other: in house protocol

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18

EC Number:

267-008-6

EC Name:

Alcohols, C16-18

Cas Number:

67762-27-0

Molecular formula:

C16 H34 O

IUPAC Name:

Alcohols, C16-18

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report):Tradename Alfol 1618 C16-18 alcohols 100% linear

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: Rat (Sprague-Dawley)
- Source: Not reported
- Weight at study initiation: 200-245 g
- Group size: 5 (a group of 5 is used at each dose level but it is not clear how the sexes were distributed among the dose levels as the report states both were used). The rats were fasted.
- Controls: none
Sex: male/female
No. of Animals: 20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 20% aqueous suspension prepared in 0.5% gum tragacanth

Details on oral exposure:

Vehicle: other: 20% aqueous suspension prepared in 0.5% gum tragacanth
Doses: 2, 4, 5 and 10 g/kg,

Doses:

Doses: 2, 4, 5 and 10 g/kg,

No. of animals per sex per dose:

Group size: 5 (a group of 5 is used at each dose level but it is not clear how the sexes were distributed among the dose levels as the report states both were used).

Control animals:

no

Details on study design:

ADMINISTRATION: Gavage
- Doses: 2, 4, 5 and 10 g/kg (based on range finding test)
- Doses per time period: single
- Volume administered or concentration: 20% aqueous suspensioin in 0.5% gum tragacanth.
- Post dose observation period: 14 days

EXAMINATIONS: Mortality was recorded.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

other: Not reported.

Gross pathology:

No significant gross abnormalities were seen at autopsy.

Other findings:

NECROPSY FINDINGS: Not carried out.
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: Combined test group.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 in male/female rats is >10000 mg/kg bw . No significant gross abnormalities were seen at autopsy.
The rat oral LD50 for Alcohols, C16-18 was >10000 mg/kg bw.

Executive summary:

The rat oral LD50 for Alcohols, C16-18 was >10000 mg/kg bw.