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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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