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Toxicological information

Acute Toxicity: oral

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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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1969
Report Date:
1969
Reference Type:
publication
Title:
Unnamed
Year:
1962
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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).