1,3-Propanediaminium, 2-hydroxy-N1,N3-bis(2-hydroxyethyl)-N1,N1,N3,N3-tetramethyl-, chloride (1:2)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The results show that the test strains are sensitive to the positive control mutagens and had a spontaneous reversion rate well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents. The metabolic activation using the S9 activation mixture shows an active microsomal preparation. Using the same test conditions, there was no detectable genotoxic activity associated with the single test concentration of ColaMoist 200, 5% aqueous Lot #: 10756B05, neither in the absence or presence of the S9 enzyme activation, at the foHowing concentrations: 5 milligrams/plate of test material, which equates to 250 micrograms / plate of active ingredient.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only a screening test at one concentration of 5 mg/plate as a 5% solution of the 70% product. This is approx 0.2 mg/plate (200 µg) actives. Only a single experiment was performed

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

Principles of method if other than guideline:

The purpose of this protocol is to evaluate the ability of a chemical, formulation or extract to induce a mutagenic response in five different strains; namely Salmonella typhimurium, namely TA 97a, TA98, TA 100, TA 102, TA 1535. Test materials are screened at different dose levels by plating them with the tester strains both with and without Aroclor™ 1254 induced rat liver microsomes (59). Materials are considered mutagenic if they
cause an increase in revertant colonies above the spontaneous background (i.e. no test material) level.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Details on test system and experimental conditions:

In this protocol, a complete set of positive and negative controls is included with each assay, and is plated routinely with all of the tester strains.
Aroclor™ 1254 induced rat liver microsomes are included to mimic the in vivo activity of the liver enzymes in activating some pro"mutagens to mutagenic status. This method is compliant with the OECD TG 471, Bacterial Reverse Mutation Test (1997) guidance document.

Species / strain:

S. typhimurium, other: Salmonella typhimurium TA97a, S. typhimurium TA 98, S. typhimurium TA100, S. typhimur ium TA102, S. typhimurium TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

none detected

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative

The results show that the test strains are sensitive to the positive control mutagens and had a spontaneous reversion rate well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents.
The metabolic activation using the S9 activation mixture shows an active microsomal preparation.
Using the same test conditions, there was no detectable genotoxic activity associated with the single test concentration of ColaMoist 200, 5% aqueous Lot #: 10756B05, neither in the absence or presence of the S9 enzyme activation, at the foHowing concentrations: 5 milligrams/plate of test material, which equates to 250 micrograms / plate of active ingredient.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Supporting studies for a similar substance, (choline chloride CAS 67 -48 -1), gave the following conclusions in an OECD SIDS report from 2004;

Choline chloride does not have any structural alerts for genotoxicity. It did not produce gene mutations, clastogenicity or DNA damage when tested in vitro. It can be concluded from these studies that choline chloride does not have any mutagenic potential.

Choline chloride (CAS 67-48-1) is a similar short chain quaternary amine of similar properties to ColaMoist 200. The structure of ColaMoist 200 is equivalent to a dimer of choline chloride joined through a OH-C-H linkage. Groupings are similar and therefore toxicological propertes might be expected to be similar too although cannot be confirmed.

Justification for selection of genetic toxicity endpoint
Only valid study report on the actual substance, ColaMoist 200, avaialable for this end point.