3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ceraphyl 60 was tested for mutagenicity potential using the Salmonella auxotrophe strains as described by Ames et al. in Mutation Research, 113 (1983) pp. 173-215.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Version / remarks:

Not applicable

Deviations:

no

Principles of method if other than guideline:

Test procedure based on "Revised methods for the Salmonella mutagenicity Test" by Dorothy M, Maron and Bruce N. Ames. Mutation Research 113 (1983): 173-215

GLP compliance:

yes

Remarks:

US FDA

Type of assay:

bacterial forward mutation assay

Specific details on test material used for the study:

Identity: Ceraphyl 60, Lot #7452.
Composition:Quaternium 22 CAS# 51812-80-7 in Water CAS# 7732-18-5
Description of test Material: Clear yellow oily liquid
Quantity of Test Material: 245 ml in a glass bottle with plastic lid
Storage Conditions: room temperature

Species / strain / cell type:

S. typhimurium TA 97

Species / strain / cell type:

S. typhimurium TA 98

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix from rat liver

Test concentrations with justification for top dose:

Without activation: 10 µg
With activation: Three dose levels: 0.1 µg, 1.0 µg and 10 µg

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

9-aminoacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION:
Media
(a} Minimal agar medium for mutagenicity
(b) Top Agar Medium
{c) Nutrient Broth
Post-Mitocondrial Supernatant Fraction:
(a) Induction of Rat Liver Enzymes using mMale rats (200 grams. each) for tne inductfon with a single intraperitoneal injection of Aroclor 1254 at a dosage of 500 mg/kg five days before sacrifice.
(b) Preparation of Liver Homogenate: After weighing, livers were transferred to beakers containing 3 ml of 0.15 M KCl per gram of wet liver. Livers were minced and then centrifuged for 10 minutes at 9000 g.
(c) Storage: The S-9 fraction was distributed in 2 ml portions in small vials, quickly frozen and stored at -80 c.
DURATION
- Exposure duration: incubation at 37 dC for 72 hours
THE MUTAGENICITY TEST:
conducted by adding each level of test chemical to tubes containing 0.1 ml of tester strains and 2 ml of top agar (45 DC}, The tube contents were mixed and poured on minimal agar plates , in duplicate.

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Resuls of the spot-test and mutagenicity testing without activation
	TA97	TA98	TA100
10µg A	-	-	-
10µg B	-	-	-
Negative Control A	-	-	-
Negative Control B	-	-	-
Positive control A	+	++	+++
Positive control B	+	++	++

Resuls of mutagenicity testing with S9-activation
	20µl - S9			50µl - S9
Ceraphyl 60	TA97	TA98	TA100	TA97	TA98	TA100
0.1µg A	12	21	19	21	11	25
0.1µg B	17	16	28	16	9	23
1.0µg A	16	14	30	36	20	24
1.0µg B	19	19	22	27	23	27
10µg A	33	17	28	19	29	10
10µg B	18	21	19	8	21	33
Negative Control A	14	20	17	24	20	19
Negative Control B	24	26	19	26	12	12
Positive control A	2110	1960	2004	2836	2450	1990
Positive control B	2624	2228	1898	2540	2244	2460

Conclusions:

Ceraphyl 60 was tested for mutagenicity potential using the Salmonella auxotrophe strains as described by Ames et al. in Mutation Research, 113 (1983) pp. 173-215. The results of this series of tests indicate that the material does not have mutagenic potential.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

The results of this AMES test indicate that the material does not have mutagenic potential.