Taurine

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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.