2-methylpropyl-(R)-2-hydroxypropanoate

Acute Toxicity: oral

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

Test material information

Constituent 1

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.