Alcohols, C13-15

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity screening of twenty‐five cosmetic ingredients with the salmonella/microsome test

Author:

R. D. Blevins & D. E. Taylor

Year:

1982

Bibliographic source:

J. Environ. Sci. Health, A 17 (2), 217-239 (1982)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Salmonella/microsome test (Spot test) was performed to determine the mutagenic nature of cetyl alcohol

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecan-1-ol

EC Number:

253-149-0

EC Name:

Hexadecan-1-ol

Cas Number:

36653-82-4

Molecular formula:

C16H34O

IUPAC Name:

1-Hexadecanol

Test material form:

solid

Details on test material:

- Name of test material: Cetyl alcohol
- IUPAC name: 1-Hexadecanol
- Molecular formula: C16H34O
- Molecular weight: 242.4436 g/mol
- Substance Type: Organic
- Physical State: solid

Specific details on test material used for the study:

- Name of test material: Cetyl alcohol
- IUPAC name: 1-Hexadecanol
- Molecular formula: C16H34O
- Molecular weight: 242.4436 g/mol
- Substance Type: Organic
- Physical State: solid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: LT2 - TA98, TA100, TA1535, TA1537, and TA1538

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

Postmitochondrial preparations (S9) from livers of male Sprague-Dawley rats induced with Aroclor 1254

Test concentrations with justification for top dose:

50 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Sterile double distilled water
- Justification for choice of solvent/vehicle: The chemical was soluble in Sterile double distilled water

Controls

Untreated negative controls:

yes

Remarks:

Spontaneous revertants

Negative solvent / vehicle controls:

yes

Remarks:

Sterile double distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2- aminoanthracene (all strains), 4-nitro-o-phenylene diamine (TA1538 and TA98)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (spot test)

DURATION
- Preincubation period: No data
- Exposure duration: 2 days (48 hrs)
- Expression time (cells in growth medium): 2 days (48 hrs)
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: No data

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

The toxicity of the cosmetic ingredient was evidenced by either a clearing of the bacterial lawns (the reduction of colony counts below the range of spontaneous revertants) or the appearance of pinpoint his colonies. The cosmetic ingredient was considered mutagenic if there was a significant increase (a reproducible dose related increase in the number of revertant colonies) in the number of colonies on the plate compared with both the non-treated and cosmetic ingredient treated plates.

Statistics:

Mean ± SD

Results and discussion

Test results

Species / strain:

S. typhimurium, other: LT2 - TA98, TA100, TA1535, TA1537, and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Remarks:

Results showed no significant difference in the reversion rates of the solvent control plates

Untreated negative controls validity:

valid

Remarks:

Results showed no significant difference in the reversion rates of the spontaneous reversion plates

Positive controls validity:

valid

Remarks:

Known mutagens were tested as positive controls and confirmed that each strain was responding properly to mutation

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Any other information on results incl. tables

Table: CONTROL DATA FOR MUTAGENICITY ASSAYS

Compound/Solvent	Amount per plate	S9^b	Numbers of revertant colonies/plate^a
			TA1538	TA1537	TA1535	TA100	TA98
Negative controls
Spontaneous	0µL	-	5±3(14)	3±3(14)	11±7(13)	100±26(14)	17+5(14)
		+	5+3(12)	3+2(12)	7+4(12)	70+24(12)	22+11(12)
H20	100µL	-	4±2(6)	6+2(7)	12±6(7)	95±19(7)	14±5(7)
		+	4±2(6)	3+1(6)	7+1(6)	84±22(6)	26±9(6)
Ethanol	100µL	-	6±3(6)	5±2(6)	9±6(6)	88±17(6)	21±10(5)
		+	4±3(6)	4±3(6)	10±6(6)	65±5(6)	37+2(6)
Dimethyl sulfoxide (DMSO)	100µL	-	4±4(6)	5±1(6)	6±4(6)	72±6(6)	16±3(6)
		±	3±K6)	3±2(6)	5±1(6)	70± 1(6)	25±2(6)
Positive controls
2-Aminoanthracene in DMSO	5µg	-	7±3(12)	10±3(11)	16±T0(12)	101±36(12)	11±9(12)
		±	110±45(12)	100±31(12)	440±340(12)	4000±500(12)	2900±1300(12)
4-Nitro-o-phenylene diamine in DMSO	50µg	-	160±34(12)
Sodium azide in H20	50µg	-			2500±1200(12)	3500±800(12)
9-Aminoacridine in ethanol	50µg	-		3600±1000(11)

 

Table: SPOT TEST RESULTS OF CETYL ALCOHOL USING THE SALMONELLA/MICROSOME SYSTEM

Compound/Solvent	Amount per plate	S9^b	Numbers of revertant colonies/plate^a
			TA1538	TA1537	TA1535	TA100	TA98
Cetyl alcohol	50µg	-	-	-	-	-	-
		+	-	-	-	-	-

Applicant's summary and conclusion

Conclusions:

Cetyl alcohol did not induce gene mutation in Salmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Salmonella/microsome test (Spot test) was performed to determine the mutagenic nature of cetyl alcohol. The study was performed using Salmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 with and without S9 metabolic activation system. The chemical as used at dose levels of 50µg/plate and the plates were incubated for 2 days. The plates were observed for a dose dependent increase in the number of revertants/plate. Negative and positive control plates were also made with the test plates. The negative controls were used to determine the spontaneous reversion rate to prototrophy for each strain, and to determine the effect of the solvents on the reversion rates.Cetyl alcohol did not induce gene mutation inSalmonella typhimurium LT2 - hisTA98, hisTA100, hisTA1535, hisTA1537, and hisTA1538 both in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.