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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 based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-finding toxicity data: List VII
Author:
Smyth Jr. HF et al.
Year:
1969
Bibliographic source:
Am. Ind. Hyg. J. 30, 470-476
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2009
Bibliographic source:
RIFM database

Materials and methods

Principles of method if other than guideline:
according to Smyth HF et al. Am. Ind. Hyg. Assoc. J. 23, 95, 1962
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-1-butanol

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own colony
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 90 - 120 g
- Diet (e.g. ad libitum): Rockland rat diet
- Fasting period before study: non-fasted

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water or corn oil; on occasion, a 1% solution of an aqueous solution of 25% sodium 3,9-diethyl-6-tridecanol sulfate was used as a dispersing agent
Doses:
logarithmic series differing by a factor of two

No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 value and its fiducial range are estimated by the method of Thompson (1947) using the tables of Weil (1952)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 5 726 mg/kg bw
Based on:
test mat.
95% CL:
3 856 - 8 424
Remarks on result:
other: calculated based on density = 0.81 g/cm3
Mortality:
Original value: LD50 = 7.07 mL/kg bw (95% CL: 4.82-10.4)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU