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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl ether
EC Number:
200-467-2
EC Name:
Diethyl ether
Cas Number:
60-29-7
Molecular formula:
C4H10O
IUPAC Name:
diethyl ether
Details on test material:
- Name of test material (as cited in study report): Diethyl ether
- Physical state: Clear liquid
- Lot/batch No.: 09023198
- Expiration date of the lot/batch: 09/2010
- Storage condition of test material: At room temperature

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital and β-naphthoflavone-induced rat liver microsomal fraction (S9)
Test concentrations with justification for top dose:
Toxicity experiment (experiment I): 0.156, 0.312, 0.625, 1.25, 2.5, or 5 µL/mL (± S9)
Toxicity experiment (experiment II): 0.5, 1, 2, 3, 4, or 5 µL/mL (- S9)

Mouse lymphoma assay (Experiment I): 0.039, 0.078, 0.156, 0.312, 0.625, 1.25, 2.5, or 5 µL/mL (± S9)
Mouse lymphoma assay (Experiment II): 0.1, 0.2, 0.5, 1, 2, 3, 4, or 5 µL/mL (± S9)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: RPMI + 3% horse serum (for short-term exposure) or RPMI + 7.5% horse serum (for long-term exposure)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
- RPMI + horse serum (3% of 7.5%)
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Ethylmethanesulfonate and methylmethanesulfonate (- S9) and benzo[a]pyrene (+ S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4 hours (for short-term exposure; ± S9) and 24 hours (for long-term exposure; - S9) (temperature not reported)
- Expression time (cells in growth medium): 72 hours (for short-term exposure) and 48 hours (for long term exposure) at 37 ºC

NUMBER OF REPLICATIONS: Duplicate plates/dose; independent repeat experiment was performed.
Evaluation criteria:
Criteria for determining a positive result:

- Clear and dose-related increase in the mutation frequency

- Biologically relevant response (at least a 2-fold increase of mutant frequencies related to the respective negative control values and higher than the historical range of negative controls) for at least one of the dose groups.

- Combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (slow growth colonies) indicated by a low large/small colonies ratio (1.5 times the ratio of clastogenic controls MMS and/or B[a]P) is an indication for potential clastogenic effects and/or chromosomal aberrations.

A test item is considered to be negative if there is no biologically relevant increase in the induction of mutant cells above concurrent control levels, at any dose level.
Statistics:
Not performed but not considered necessary.

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
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 with metabolic activation
negative without metabolic activation