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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
Mutations were quantified by counting anaphase aberrations. Negative (0.85 %) and positive (0.1 µg/l triethylene melamine) controls were run in parallel.
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Reference substance name:
112926-00-8
EC Number:
601-214-2
Cas Number:
112926-00-8
IUPAC Name:
112926-00-8
Details on test material:
- Name of test material (as cited in study report): Syloid 244
- Physical state: fine white powder

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: human embryonic lung cells (Wi-38)
Details on mammalian cell type (if applicable):
negative for viruses and mycoplasma
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Test concentrations with justification for top dose:
0.1-10 µg/ml (Data taken from original report. In OECD SIDS the mentioned test concentration range is 1-1000 µg/ml.)
Controls
Untreated negative controls:
yes
Remarks:
0.85 % saline
Negative solvent / vehicle controls:
yes
Remarks:
0.85 % saline
True negative controls:
no
Positive controls:
yes
Positive control substance:
triethylenemelamine
Remarks:
Migrated to IUCLID6: 0.1 µg/l

Results and discussion

Test results
Species / strain:
mammalian cell line, other: human embryonic lung cells (Wi-38)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The low (0.1 µg/ml) and intermediate (1 µg/ml) levels contained 3 % and 4 % cells with acentric fragments, respectively. The intermediate level also contained a cell with a bridge. The negative control contained only one cell with an acentric fragment. While other levels were somewhat higher in aberrrations than the negative control, they are not considered significant. The positive control contained three cells with severely pulverizied chromosomes together with the other aberrations indicated in the summary sheet.

Applicant's summary and conclusion