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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-finding toxicity data
Author:
Smyth H.F.
Year:
1954
Bibliographic source:
AMA Arch Ind Hyg Occup Med. 1954 Jul;10(1):61-8.
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report date:
1991
Reference Type:
publication
Title:
Industrial hygiene and toxicology, Second Revised Edition, Volume II
Author:
Fassett D.W.
Year:
1962
Bibliographic source:
p. 1966-1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five female Carworth Wistar per dose were exposed to the test substance. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the tables of Weil.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyraldehyde
EC Number:
201-149-6
EC Name:
Isobutyraldehyde
Cas Number:
78-84-2
Molecular formula:
C4H8O
IUPAC Name:
2-methylpropanal
Details on test material:
- Name of test material: isobutyraldehyde

Test animals

Species:
rat
Strain:
other: Carworth Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute of Industrial Research, University of Pittsburg
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 90 – 120 g
- Fasting period before study: not performed
- Diet: Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% solution of sodium 3,9-diethyl-6-tridecanol sulfate (Tergitol Penetrant 7)
Details on oral exposure:
Administered as a 20% aqueous dispersion in 1% Tergitol Penetrant 7
Doses:
2000, 3980, 7950 mg/kg
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 and its fiducial range are estimated by the method of Thompson using the tables of Weil.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 730 mg/kg bw
Based on:
test mat.
95% CL:
2 680 - 5 210
Gross pathology:
Severe gastrointestinal tract necrosis was observed. The liver, spleen and kidneys were also necrosed where they contacted the stomach wall. Lungs wer markedly congested or hemorrhagic.

Applicant's summary and conclusion

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