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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, wich meets generally accepted scientific standards. Isobutanol used as read-across partner to isobutyl-R-lactate, since being the primary metabolite.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: list V
Author:
Smyth HF, Carpenter CP, Weil CS and Pozzani UC
Year:
1954
Bibliographic source:
AMA Arch Ind Hyg Occup Med 10(1):61-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylpropan-1-ol
EC Number:
201-148-0
EC Name:
2-methylpropan-1-ol
Cas Number:
78-83-1
Molecular formula:
C4H10O
IUPAC Name:
2-methylpropan-1-ol
Constituent 2
Reference substance name:
isobutanol
IUPAC Name:
isobutanol
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): isobutyl alcohol

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own colony (Mellon Institute of Industrial Research, University of Pittsburgh
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Diet (e.g. ad libitum): ad libitum, Rockland rat diet complete
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
No data
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
Single dose oral toxicity for rats is estimated by intubation of dosages in a logarithmic series to groups of five male rats. Fourteen days after dosing, mortality is considered complete.
Statistics:
The most probable LD50 value and its fiducial range are estimated by the method of Thompson.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 460 mg/kg bw
Based on:
test mat.
95% CL:
>= 1.6 - <= 3.78

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study in rats the LD50 of isobutanol was estimated to be 2460 mg/kg bw.
Executive summary:

In an acute oral toxicity study equivalent to OECD test guideline 401, 5 male Carworth-Wistar rats were given a single oral dose of isobutanol. The animals were observed for 14 days after the single exposure. The oral LD50 reported in this study is 2460 mg/kg bw.