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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Meets basic scientific principles.
Principles of method if other than guideline:
Study pre-dates guidelines. Principles of method similar to those of guideline studies.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks of age
- Weight at study initiation: 90 – 120 grams
- Fasting period before study: not fasted before dosing
- Diet (e.g. ad libitum): Rockland rat diet complete
Route of administration:
oral: gavage
Vehicle:
other: Chemicals were diluted with water, corn oil, or a 1% solution of sodium 3, 9-diethyl-6-tridecanol sulfate (Tergitol Penetrant 7) when necessary to bring the volume given one rat to between 1 and 10 ml.
Doses:
Single dose. The dosages were arranged in a logarithmic series.
No. of animals per sex per dose:
5 male rats per group
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
Based upon the mortalities observed during a 14-day observation period, the most probable LD50 value and its fiducial range was estimated by the method of Thompson using the Tables of Weil. The reported range shows limits of ± 1.96 standard deviations.
Sex:
male
Dose descriptor:
LD50
Effect level:
6 750 mg/kg bw
Remarks on result:
other: The reported range was 6,160 – 7,380 mg/kg bw.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an early study, Smyth et al (1954) reported an acute oral LD50 value of 6750 mg/kg for isopropyl acetate in male rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 750 mg/kg bw
Quality of whole database:
ok

Additional information

Justification for selection of acute toxicity – oral endpoint
Best availble data

Justification for classification or non-classification