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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.3.1975-25.2.1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976
Reference Type:
publication
Title:
Genetics of somatic mammalian cells. VII. Induction and isolation of nutritional mutants in Chinese hamster cells.
Author:
Kao, F.T. and T.T. Puck
Year:
1968
Bibliographic source:
Proc. Nat. Acad. Sci., 60, 1275 - 1281.
Reference Type:
publication
Title:
Genetics of somatic mammalian cells. IX. Quantitation of mutagenesis by physical and chemical agents.
Author:
Kao, F.T. and T.T. Puck
Year:
1969
Bibliographic source:
J. Cell Physiol., 74(3), 245 - 257.
Reference Type:
publication
Title:
Genetics of somatic mammalian cells. V. Treatment with 5-bromodeoxyuridine and visible light for isolation of nutritionally deficient mutants.
Author:
Puck, T.T. and F.T. Kao
Year:
1967
Bibliographic source:
Proc. Nat. Acad. Sci., 58, 1227- 1234.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
yes
Remarks:
No metabolic activation, two dose levels, no negative control.
Principles of method if other than guideline:
Wild type cells (Kao and Puck, 1968) capable of growth in both a minimal and enriched medium were exposed. Concentrations were selected from a single cell survival curve obtained according to the method of Puck and Kao (1967). Potential mutants were isolated by the BudR-visible light technique and confirmed by plating the cells in both aforesaid media. A mutant was defined as having growth capability in only the enriched medium. The positive control was ethylmethanesulfonate (Kao and Puck, 1969).
GLP compliance:
no
Remarks:
Unlikely. Study pre-dated even USFDA GPLs.
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol trinitrate
EC Number:
200-240-8
EC Name:
Glycerol trinitrate
Cas Number:
55-63-0
Molecular formula:
C3H5N3O9 C3H5(NO3)3
IUPAC Name:
propane-1,2,3-triyl trinitrate
Details on test material:
- Name of test material (as cited in study report): Trinitroglycerin, TNG
- Substance type: organic substance
- Physical state: capsules, 10% mixture in lactose
- Source: SDM No.17, Atlas Chemical Division, ICI America Inc., Wilmigton, DE

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
- Wild type Chinese hamster ovary cells.
Metabolic activation:
without
Test concentrations with justification for top dose:
50 µg/ml, 144.8 µg/ml.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Evaluation criteria:
Mutagenesis was measured relative to the known mutagen ethyl methanesulfonate.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative without metabolic activationNo mutagenic effects were evident from TNG under the conditions of this test.