2-ethylhexan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with some resctrictions in documentation

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1969

Report date:

1969

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

non-fasted animals

GLP compliance:

no

Remarks:

Pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2-ethylhexan-1-ol

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellon Institute of Industrial Research, Pittsburgh, Pennsylvania
- Age at study initiation: 4 -5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: none
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete
- Acclimation period: not required; rats were reared at the Institute's own facilities

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

Dosages were given in a logarithmic series differing by a factor of 2. Doses actually used are not specified.

No. of animals per sex per dose:

5 male rats per dose level.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no

Statistics:

LD50 values were calculated by the method of Thompson [Thompson WR (1947) Bacteriol Rev 11:115]. The figures in parentheses show the limits of +/- 1.96 standard deviations.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 047 mg/kg bw

Any other information on results incl. tables

RS-Freetext:
LD 50 = 2.460 ml/kg (1.820 - 3.300 ml/kg). Taking the density into account  (0.832 kg/l) this 
corresponds to 2047 (1514 - 2746) mg/kg.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was 2047 mg/kg bw in male rats.

Executive summary:

The acute oral toxicity of 2 -EH was determined in groups of 5 male Wistar rats receiving the test material by oral gavage. The dosages were spaced by a factor of 2. The observation period was 14 days. The LD50 and a range of +/- 1.96 SD was calculated according to the method of Thomson (1947). Overall the study was conducted in accordance with the recently replaced OECD test guideline 401.

The acute oral LD50 was 2047 mg/kg bw in rats (Smyth et al., 1969).