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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
yes
Remarks:
- source/origin, conditions of cultivation or maintenance of the test system, and temperature of exposure was not provided in the study report
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Isopropyl ether (IPE)
- Physical state: Colourless, clear, volatile liquid
- Analytical purity: 98.5%
- Lot/batch No.: Indent 9200/9944

Method

Species / strain
Species / strain / cell type:
primary culture, other: Rat liver (RL4) cells
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
without
Test concentrations with justification for top dose:
Growth inhibition assay: a range of concentrations from 0.1 to 1,200 µg/mL
Chromosome assay: 0, 300, 600, or 1,200 µg/mL
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Control was used; however, it is unclear if the control cultures were solvent-treated or untreated.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
- Control was used; however, it is unclear if the control cultures were solvent-treated or untreated.
True negative controls:
no
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in cell culture

DURATION
- Exposure duration: 24 hours (temperature not reported)

NUMBER OF REPLICATIONS: Each concentration and control were tested in triplicate (independent repeat was not performed)

NUMBER OF CELLS EVALUATED: 100 cells/culture (and, therefore, 300 cells/concentration).
Evaluation criteria:
The percentage of mitotic cells (mitotic index) was calculated.
Statistics:
None reported.

Results and discussion

Test results
Species / strain:
primary culture, other: Rat liver (RL4) cells
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
- the test substance did not appear to inhibit the growth of cells at any concentration
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation

It was concluded that di-isopropyl ether did not induce chromosome damage in cultured rat liver (RL4) cells under the experimental conditions described.