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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see “remarks”
Remarks:
GLP-Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
refer to analogue justification provided in IUCLID section 13

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)
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylidynetrimethanol
EC Number:
201-074-9
EC Name:
Propylidynetrimethanol
Cas Number:
77-99-6
Molecular formula:
C6H14O3
IUPAC Name:
2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Method

Target gene:
HPRT locus
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital-naphthoflavone induced rat liver S9 (male wistar rats, 8-12 weeks old)
Test concentrations with justification for top dose:
experiment I:
with and without S9-mix: 43.8, 87.5, 175, 350 700, 1400 µg/ml
incubation time: 4 hours
experiment II:
with S9-mix, incubation time: 4 hours:
43.8, 87.5, 175, 350 700, 1400 µg/ml

without S9-mix, incubation time:24 hours:
43.8, 87.5, 175, 350 700, 1400 µg/ml

Vehicle / solvent:
test item was dissolved in deionised water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: in the presence of S9-mix: 7.12 dimethylbenz(a)anthracene (DMBA); without S9-mIx: ethylmethane sulfonate (EMS)
Details on test system and experimental conditions:
according to the respective guideline
Evaluation criteria:
a test item is classified as mutagenic if it reproducibly induces a muation frequency that is three times above the sponontaneous mutatieon frequecy at least at one of the concentrations in theexperiment
Statistics:
linear regression (latest squares)

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: preliminary toxicity tests
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
negative