Isopropyl palmitate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1981-09-09 to 1991-09-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

limited documentation, incomplete strain selection

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl myristate

EC Number:

203-751-4

EC Name:

Isopropyl myristate

Cas Number:

110-27-0

Molecular formula:

C17H34O2

IUPAC Name:

isopropyl myristate

Details on test material:

- Name of test material (as cited in study report): Isopropylmyristate
- Analytical purity: no data

Method

Target gene:

Genes involved in Histidine synthesis

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other:

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

other:

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix (Aroclor 1254 induced)

Test concentrations with justification for top dose:

0, 4, 20, 100, 500 and 2500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Acetone

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

Acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-Nitro-o-phenylendiamin

Remarks:

TA1537, TA1538 and TA98 without metabolic activation

Controls 2

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

Acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA1535 and TA100 without metabolic activation

Controls 3

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

Acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

All strains with metabolic activation

Evaluation criteria:

Revertant colonies were counted and the means and standard deviations were calculated and compared to the controls.

Statistics:

Means and standard deviations were calculated

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
The vehicle acetone with 100 µL/plate had cytotoxic effects on the tester strains TA 100 and TA 1537 with and without metabolic activation. Therefore additional experiments with 50µL acetone/plate with these two strains were performed. These experiments lead to valid results except for TA 1537 without activation. To obtain reliable results and for the comparability of the two series of experiments, the relative numbers of revertants in comparison to the vehicle control were calculated (Table 2).

Any other information on results incl. tables

Table 1: Maximum number of revertants

	Maximum number of revertants (dose level [µg/mL])
	Negative control		Positive control		Treatment
Strain	With S9	Without S9	With S9	Without S9	With S9	Without S9
TA 98	24	20	796	843	25 (2500)	18 (4)
TA 100	150	49	935	375	128 (500)	49 (500)
TA 1535	13	6	145	336	11 (2500)	9 (2500)
TA 1537	13	8	275	--	10 (4)	--
TA 1538	27	16	376	662	20 (100)	17 (500)

Table 2: Maximum relative number of revertants

	Maximum relative number of revertants (dose level [µg/mL])
	Negative control		Positive control		Treatment
Strain	With S9	Without S9	With S9	Without S9	With S9	Without S9
TA 98	1	1	33.6	42.2	1.03 (2500)	0.90 (4)
TA 100	1	1	6.2	7.6	0.85 (500)	0.99 (500)
TA 1535	1	1	11.2	58.9	0.81 (2500)	1.58 (2500)
TA 1537	1	1	21.5	--	0.74 (4)	--
TA 1538	1	1	13.9	40.6	0.72 (100)	1.01 (500)

The results for TA 1537 without S9 -mix were not valid. Although the targets of reverse mutations are different in TA 1537 and TA 98, the possible mutational event in both strains is frameshift. TA 98 is additionally more sensitive to mutations because it carries the R-factor (pKM101) plasmid. The fact that there is no increase in revertants in TA 98 without S9 -mix, gives evidence that there would be no increase of revertants in TA 1537 as well. Therefore it can be concluded that the test substance showed no increase in the number of revertants at any concentration in any tester strain. The test substance is non-mutagenic.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative