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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09.05.1994 - 23.08.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid
Test material form:
solid: crystalline
Specific details on test material used for the study:
A 3 kg sample of MTC Taurine A (lot no. 302-3), fine opaque/white crystals and a 3 kg sample of MTC Taurine B (lot no. OISRM), a fine white aggregated crystalline powder, both contained in clear plastic jars, were received from Mitsui Toatsu Chemicals Incorporated on 13 April 1994. They were stored cool in the dark until required. The ident'ity, strength, purity and stability of the test materials were the responsibility of the Sponsor.

Method

Target gene:
HIS Operon, TRP operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Arocror 1254 induced rat liver S9 mix
Test concentrations with justification for top dose:
from 50 to 5000 ug per plate (toop dose according to guideline)
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
methylmethanesulfonate
other: 2 -Aminoanthracene
Details on test system and experimental conditions:
According to guideline
Rationale for test conditions:
According to guideline
Evaluation criteria:
According to guideline
Statistics:
According to guideline

Results and discussion

Test results
Key result
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
It was concluded that MTC Taurine A and MTC Taurine B were devoid of mutagenic activity under the conditions of the test.