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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, accepatable for assessment

Data source

Reference
Reference Type:
publication
Title:
Screeening of Safrole, Eugenol, their Ninhydrine Positive Metabolites and Selected Secondary Amines for Potential Mutagenicity
Author:
Green, N.R.; Savage, J.R.
Year:
1978
Bibliographic source:
Mutation Research 57, 115 - 121

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Bacterial Reverse Mutation Assay (Ames test). The other 2 methods: microsomial mutagnesis assay, host mediated assay.
Scientific study.
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Type of assay:
other: 3 different methods: direct bacterial assay (ames test), microsomial mutagnesis assay, host mediated assay.

Test material

Constituent 1
Chemical structure
Reference substance name:
L-proline
EC Number:
205-702-2
EC Name:
L-proline
Cas Number:
147-85-3
Molecular formula:
C5H9NO2
IUPAC Name:
L-proline

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1532, TA 1964, TA 1530 for Ames test and microsomial mutagenesis assay. S. typhimurium TA 1951, TA 1952, TA 1534, TA 1950 for host-mediated assay.
Additional strain / cell type characteristics:
other: TA 1535, TA 1532, TA 1964, TA 1530: defective excesion-repair system. TA 1951, TA 1952, TA 1534, TA 1950: histidine auxotroph, defective excesion-repair system, partially defective lipopolysaccharide moiety.
Metabolic activation:
with and without
Metabolic activation system:
Ames test and host mediated assay: no activation. Microsomal mutagenesis assay: mouse-liver post-mitochondrial fraction
Test concentrations with justification for top dose:
Ames test: no data
microsomial mutagenesis assay: 0.5 M
host mediated assay. 800 mg/kg
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: various

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1532, TA 1964, TA 1530 for Ames test and microsomial mutagenesis assay. S. typhimurium TA 1951, TA 1952, TA 1534, TA 1950 for host-mediated assay.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 1535, TA 1532, TA 1964, TA 1530 for Ames test and microsomial mutagenesis assay. S. typhimurium TA 1951, TA 1952, TA 1534, TA 1950 for host-mediated assay.
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

L-proline did not show mutagenicity in the Ames test, the microsomial mutagenesis assay and the host mediated assay under the conditions of the study.