Benzoyl chloride, 4-[[(2-methoxybenzoyl)amino]sulfonyl]-

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

OECD TG 471 (Ames): mutagenic (without and with S9 mix in strain TA 102)

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb - August 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1997

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix of Aroclor 1254 induced rats

Test concentrations with justification for top dose:

16, 50, 158, 500, 1581, 5000 µg/plate for bacteria strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 (plate incorporation and preincubation method)
500, 1000, 2000, 3000, 4000 and 5000 µg/ tube for strain TA102 (preincubation method only)

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide and 2-aminoanthracene

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

other: TA 98, TA 100, TA 1535, TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

starting from 1581 µg

Vehicle controls validity:

valid

Positive controls validity:

valid

Conclusions:

Weak positive findings in strain TA 102 with and without metabolic activation.

Executive summary:

The Salmonella/microsome test, employing doses of up to 5000 ug per plate, showed AE 0001789-Amidchlorid to produce bacteriotoxic effects, starting at 1581 ug per plate.
Evaluation of individual dose groups, with respect to relevant assessment parameters (dose effect, reproducibility) revealed biologically relevant variations from the respective negative controls for TA 102. These were regarded as mutagenic effects of AE 0001789-Amidchlorid. Since the observed effect was weak and only detectable in high doses, it may be assumed, that the effect may be due to a by-product and not to AE 0001789-Amidchlorid itself.
In spite of the low doses used, positive controls increased the mutant counts to well over those of the negative controls, and thus demonstrated the system's high sensitivity. Due to this sensitivity, indications of mutagenic effects of AE 0001789-Amidchlorid could be found at assessable doses of up to 5000 ug per plate in Salmonella typhimuriumTA102. Due to these results the tested batch of AE 0001789-Amidchlorid has to be regarded as mutagenic.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the positive study results (Ames test) a classification for genotoxicity warrants further investigations.