Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from peer review publication

Data source

Reference
Reference Type:
publication
Title:
CHROMOSOME TESTS WITH 134 COMPOUNDS ON CHINESE HAMSTER CELLS IN VITRO -- A SCREENING FOR CHEMICAL CARCINOGENS
Author:
MOTOI ISHIDATE, Jr. and SHIGEYOSHI ODASHIMA
Year:
1977
Bibliographic source:
Mutation Research, 48 (1977) 337—354

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mer mentiond below
Principles of method if other than guideline:
In vitro chromosomal aberration was conducted on Chinese hamster fibroblast cell line to evaluate genetoxicity effects of chemical.
GLP compliance:
no
Type of assay:
gene mutation assay in fungi

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyl 4-hydroxybenzoate
EC Number:
224-208-8
EC Name:
Isobutyl 4-hydroxybenzoate
Cas Number:
4247-02-3
Molecular formula:
C11H14O3
IUPAC Name:
2-methylpropyl 4-hydroxybenzoate
Details on test material:
- Name of test material: Isobutyl 4-hydroxybenzoate
- Molecular formula: C11H14O3
- Molecular weight: 194.23 g/mol
- Substance type: Organic
- Physical state: Solid

Method

Target gene:
Chinese hamster fibroblast cell line
Species / strain
Species / strain / cell type:
other: Chinese hamster fibroblast cell line
Details on mammalian cell type (if applicable):
- Type and identity of media: The cells had been maintained by 5-day passages and grown in a monolayer in petri dishes with Eagle's MEM (GIBCO F-11) supplemented with 10% calf serum
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
no data
Test concentrations with justification for top dose:
0.03%
Vehicle / solvent:
- Vehicle(s)/solvent(s) used:Ethanol
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period:48-h
Evaluation criteria:
% aberration

Results and discussion

Test results
Species / strain:
other: Chinese hamster fibroblast cell line
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data
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

Negative effects were known in chromosomal aberration test when tested in Chinese hamster fibroblast cell line with dose concentration of 03.% in ethanol.
Executive summary:

Chromosomal aberration test was conducted onChinese hamster fibroblast cell line for the chemical Isobuyl paraben.The Cells were treated with colcemid (0.2 pg/ml) for 2 h, and after trypsinization, they were incubated in 0.075 M KC1 hypotonic solution for 15 min. at 37°C.The dose concentration was 0.3% .

The test produced no chromosomal aberration after 48-h.Hence,Negative effects were known in chromosomal aberration test when tested inChinese hamster fibroblast cell line with dose concentration of 03.% in ethanol.