Fatty acids, C18-unsaturated, 2-hexyldecyl ester

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test (OECD 471): negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 100 and TA 98, and E. coli WP2 uvrA and WP2 uvrA pKM 101

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

30 Jul - 07 Aug 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted Jul 1997

Deviations:

yes

Remarks:

analytical purity of the test substance was not reported

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

analytical purity of the test substance was not reported

GLP compliance:

yes (incl. QA statement)

Remarks:

Direccion General de Farmacia y Productos Sanitarios, Consejera de Sanidad y Consumo, Madrid, Spain

Type of assay:

bacterial reverse mutation assay

Target gene:

his operon

Species / strain / cell type:

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

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Metabolic activation system:

Cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

0.05, 0.15, 0.5, 1.5, 5 µL/plate, with and without metabolic activation

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: no data

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

solvent type not reported

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-nitrofluorene, sodium azide, 9-aminoacridine, 4-nitroquinoline-N-oxide, 2-aminoanthracene

Remarks:

See 'Any other information on material and methods incl. tables' for details on positive controls

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); if the first assay result was negative the second assay was performed as a preincubation assay, and if the first assay result was positive the second assay was performed as a plate incorporation assay

DURATION
- Preincubation period: 20 min (second assay)
- Exposure duration: 48 hrs

NUMBER OF REPLICATIONS: 3 replications in 2 independent assays

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

A test substance is considered positive (mutagenic) in the test if:
It induces a dose-resonse in the range tested and/or
a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with ot without mutagenic activation is observed.

Statistics:

Mean values and standard deviation were calculated.

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed at any dose level, with and without metabolic activation.

COMPARISON WITH HISTORICAL CONTROL DATA: yes, the negative control and test substance results fell within the historical control data range (see Table 1 under 'Any other information on material and methods incl. tables').

ADDITIONAL INFORMATION ON CYTOTOXICITY: no cytotoxicity was observed up to and including the highest dose level, which is the limit dose level recommended in the OECD 471 guideline.

OTHER: Only 2-amino anthracene was used as a positive control, however, dilutions of the sample S9-mix were tested and confirmed to activate benzo(a)pyrene and 2-amino anthracene.

Table 2. Test results of experiment 1 (plate incorporation method)

With or without S9-Mix	Test substance concentration (μL/plate)	Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation)
		Base-pair substitution type			Frameshift type
		TA 100	TA1535	WP2 uvR	TA98	TA1537
-	Solvent	49.7 ± 26.1	14.7 ± 1.5	76.0 ± 8.2	14.7 ± 2.5	27.3 ± 5.5
-	0.05	41.0 ± 4.0	14.7 ± 3.8	77.3 ± 22.9	21.3 ± 3.8	28.0 ± 8.9
-	0.15	37.7 ± 3.8	11.0 ± 1.0	59.7 ± 7.2	16.0 ± 7.1	29.0 ± 3.0
-	0.5	36.3 ± 6.8	13.3 ± 3.1	59.7 ± 4.9	20.0 ± 4.6	40.0 ± 21.0
-	1.5	42.7 ± 4.7	12.0 ± 2.6	55.7 ± 21.1	16.3 ± 4.9	34.3 ± 9.6
-	5.0	47.3 ± 10.1	10.3 ± 2.1	43.3 ± 18.1	17.0 ± 1.0	37.3 ± 8.6
Positive controls, –S9	Name	NaN3	NaN3	4 -NNO	2-NF	9-AA
	Concentrations positive controls (μg/plate)	10	30	7	90	100
	Mean No. of colonies/plate (average of 3 ± SD)	556.3 ± 55.2	184.7 ± 46.8	610.0 ± 30.3	399.3 ± 25.0	215.0 ± 1.0
+	Solvent	44.0 ± 2.0	15.7 ± 7.4	71.7 ± 14.7	20.3 ± 4.7	8.7 ± 3.1
+	0.05	52.0 ± 6.1	14.3 ± 7.8	90.7 ± 17.5	27.7 ± 1.5	10.0 ± 5.6
+	0.15	67.0 ± 14.7	15.3 ± 5.1	76.0 ± 39.9	27.0 ± 5.3	5.7 ± 2.1
+	0.5	47.0 ± 10.1	15.7 ± 3.5	87.3 ± 29.9	26.3 ± 5.0	8.7 ± 0.6
+	1.5	49.7 ± 13.3	10.7 ± 1.2	80.7 ± 24.0	21.7 ± 4.5	9.0 ± 2.6
+	5.0	61.3 ± 9.0	10.7 ± 2.5	64.7 ± 29.7	19.7 ± 4.7	7.0 ± 4.6
Positive controls, +S9	Name	2-AA	2-AA	2-AA	2-AA	2-AA
	Concentrations (μL/plate)	10	30	7	10	30
	Mean No. of colonies/plate (average of 3 ± SD)	305.0 ± 41.6	326.0 ± 10.8	320.0 ± 6.2	611.3 ± 108.1	320.0 ± 6.2

2-NF: 2-nitrofluorene

NaN3: sodium azide

9-AA: 9-aminoacridine

4-NNO: 4-nitroquinoline-N-oxide

2-AA: 2-aminoanthracene

 

Table 3. Test results of experiment 2 (preincubation method)

With or without S9-Mix	Test substance concentration (μL/plate)	Mean number of revertant colonies per plate (average of 3 plates ± Standard Deviation )
		Base-pair substitution type			Frameshift type
		TA 100	TA1535	WP2 uvR	TA98	TA1537
-	Solvent	64.3 ± 5.1	9.7 ± 5.5	74.7 ± 19.0	22.7 ± 6.5	9.7 ± 3.2
-	0.05	39.0 ± 1.0	12.3 ± 5.8	113.0 ± 15.7	23.3 ± 3.1	11.3 ± 3.1
-	0.15	44.3 ± 4.2	12.3 ± 5.0	103.7 ± 17.6	24.0 ± 2.0	11.0 ± 3.5
-	0.5	38.7 ± 14.2	9.0 ± 6.9	116.3 ± 10.8	22.7 ± 2.1	10.7 ± 1.5
-	1.5	34.0 ± 3.0	16.7 ± 4.9	107.3 ± 10.1	29.3 ± 7.6	11.7 ± 5.5
-	5.0	43.3 ± 10.7	10.0 ± 2.6	116.7 ± 10.1	19.3 ± 9.9	11.0 ± 5.2
Positive controls, –S9	Name	NaN3	NaN3	4-NNO	2-NF	9-AA
	Concentrations (μL/plate)	10	30	7	90	100
	Mean No. of colonies/plate (average of 3 ± SD)	580.0 ± 8.2	504.0 ± 27.6	810.0 ± 77.3	544.3 ± 417.5	682.7 ± 91.5
+	Solvent	47.0 ± 9.8	17.7 ± 5.5	45.3 ± 5.9	15.0 ± 4.0	19.3 ± 9.1
+	0.05	52.0 ± 6.6	18.0 ± 3.0	74.0 ± 5.6	17.3 ± 3.8	25.7 ± 1.5
+	0.15	51.3 ± 9.0	13.0 ± 7.9	80.0 ± 6.1	18.0 ± 4.4	24.7 ± 8.7
+	0.5	58.7 ± 8.5	16.0 ± 5.0	63.7 ± 14.5	17.7 ± 1.5	18.7 ± 3.1
+	1.5	58.7 ± 4.2	19.0 ± 6.2	76.0 ± 18.0	14.0 ± 3.6	18.3 ± 6.0
+	5.0	56.3 ± 4.1	15.7 ± 3.1	78.7 ± 26.1	16.0 ± 4.4	32.0 ± 6.9
Positive controls, +S9	Name	2-AA	2-AA	2-AA	2-AA	2-AA
	Concentrations (μL/plate)	10	30	7	10	30
	Mean No. of colonies/plate (average of 3 ± SD)	352.7 ± 62.0	284.7 ± 11.7	475.7 ± 84.4	299.7 ± 79.6	161.7 ± 27.5

2-NF: 2-nitrofluorene

NaN3: sodium azide

9-AA: 9-aminoacridine

4-NNO: 4-nitroquinoline-N-oxide

2 -AA: 2 -aminoanthracene

Conclusions:

CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Reference 2

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

11 - 20 Mar 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

his operon

Species / strain / cell type:

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

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

10, 33, 100, 333 and 1000 µg/plate, with and without metabolic activation

Vehicle / solvent:

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

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

sodium azide

methylmethanesulfonate

other: daunomycine, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3 replications in 2 independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (reduction of bacterial background lawn, increase in size of the microcolonies, reduction of the revertant colonies)

OTHER:
the results of the dose range-finding test were included as part of experiment 1

Evaluation criteria:

A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following
criteria:
a) The negative control data (number of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain (see Table 1)
b) The positive control chemicals should produce responses in all tester strains which are within the laboratory historical range documented for each positive control substance. Furthermore, the mean plate count should be at least two times the concurrent vehicle control group mean
c) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.

A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants compared to the solvent control value in any of the tester strains, either with or without metabolic activation. However, any plate with a mean plate count of less than 20 colonies is considered to be not significant and the result will be disregarded.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was observed in all strains, with and without metabolic activation, from 1000 µg/plate and above.

RANGE-FINDING/SCREENING STUDIES:
A dose range-finding test with strain TA100 and the WP2uvrA strain (both with and without S9- mix) was performed to select suitable doses for the main experiments. Eight concentrations (3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate) were tested in triplicate. The results were reported as a part of the first experiment of the mutation assay. The highest concentration of the test substance used in the main experiments was the level at which the test substance exhibited limited solubility. Precipitation was observed on the plates from 1000 µg/plate and above in both strains.

COMPARISON WITH HISTORICAL CONTROL DATA: yes, the spontaneous mutation rate of each tester strain per plate were within the characteristic spontaneous mutation range (see Table 1 under 'Any other information on materials and methods incl. tables'), with the exception of TA 100 without metabolic activation. The value was slightly outside the limit of the range, therefore the validity of the test was considered not to be affected.

ADDITIONAL INFORMATION ON CYTOTOXICITY: no cytotoxicity was observed at any concentration level, with or without metabolic activation (see Table 2 and 3).

Table 2: Results of experiment 1 

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 3 plates ± SD)
		Base-pair substitution type		Frameshift type
		TA 100	TA 1535	WP2 uvrA	TA 98	TA 1537
-S9	ethanol	55 ± 3	12 ± 3	14 ± 6	16 ± 2	6 ± 1
-S9	3	55 ± 6	-	11 ± 2	-	-
-S9	10	63 ± 7	10 ± 4	10 ± 3	15 ± 6	7 ± 2
-S9	33	49 ± 7	8 ± 3	11 ± 1	16 ± 1	7 ± 4
-S9	100	59 ± 2	8 ± 1	12 ± 2	15 ± 3	5 ± 3
-S9	333	57 ± 7	7 ± 2	11 ± 6	17 ± 4	5 ± 3
-S9	1000 SP	70 ± 6	10 ± 3	10 ± 2	16 ± 1	4 ± 1
-S9	3300 SP	77 ± 9	-	12 ± 2	-	-
-S9	5000 SP	59 ± 13	-	10 ± 4	-	-
Positive controls, –S9	Name	MMS	SA	4-NQO	DM	9-AC
	Concentrations (μg/plate)	650	1	10	4	60
		529 ± 23	121 ± 18	291 ± 26	375 ± 36	185 ± 66
+S9	ethanol	71 ± 3	8 ± 2	10 ± 1	26 ± 2	8 ± 1
+S9	3	66 ± 10		11 ± 4
+S9	10	62 ± 3	9 ± 2	9 ± 4	25 ± 4	8 ± 3
+S9	33	64 ± 3	9 ± 3	14 ± 3	22 ± 2	6 ± 2
+S9	100	50 ± 8	9 ± 3	15 ± 3	24 ± 5	6 ± 2
+S9	333	45 ± 5	13 ± 4	10 ± 3	18 ± 4	6 ± 4
+S9	1000 SP	54 ± 8	12 ± 4	12 ± 6	23 ± 5	8 ± 1
+S9	3330 SP	54 ± 9	-	12 ± 1	-	-
+S9	5000 SP	51 ± 9	-	12 ± 2	-	-
Positive controls, +S9	Name	2-AA	2-AA	2-AA	2-AA	2-AA
	Concentrations (μg/plate)	1	2.5	5	2.5	2.5
		1182 ± 90	240 ± 8	88 ± 10	1047 ± 57	713 ± 149

MMS = methylmethanesulfonate

SA = sodium azide

4-NQO = 4-nitroquinoline-N-oxide

9-AC = 9-aminoacridine

DM = daunomycine

2-AA = 2-aminoanthracene

SP = slight precipitate

 

Table 3: Results of experiment 2

With or without S9-Mix	Test substance concentration (μg/plate)	Mean number of revertant colonies per plate (average of 3 plates ± SD)
		Base-pair substitution type		Frameshift type
		TA 100	TA 1535	WP2 uvrA	TA 98	TA 1537
-S9	ethanol	88 ± 10	10 ± 2	10 ± 6	22 ± 7	5 ± 2
-S9	10	94 ± 13	9 ± 3	9 ± 2	17 ± 2	7 ± 3
-S9	33	93 ± 3	8 ± 3	12 ± 2	17 ± 3	5 ± 1
-S9	100	90 ± 7	10 ± 3	9 ± 2	14 ± 5	5 ± 3
-S9	333	90 ± 9	6 ± 3	11 ± 3	15 ± 6	5 ± 1
-S9	1000 SP	77 ± 5	6 ± 3	9 ± 4	14 ± 4	7 ± 4
Positive controls, –S9	Name	MMS	SA	4-NQO	DM	9-AC
	Concentrations (μg/plate)	650	1	10	4	60
		714 ± 49	152 ± 10	936 ± 118	598 ± 16	251 ± 100
+S9	ethanol	99 ± 8	8 ± 4	11 ± 7	15 ± 1	7 ± 3
+S9	10	98 ± 10	8 ± 3	7 ± 1	17 ± 3	4 ± 2
+S9	33	103 ± 21	6 ± 3	8 ± 2	27 ± 6	7 ± 1
+S9	100	98 ± 9	8 ± 3	13 ± 7	21 ± 7	6 ± 2
+S9	333	93 ± 6	7 ± 5	8 ± 3	20 ± 5	8 ± 2
+S9	1000 SP	112 ± 2	9 ± 3	8 ± 1	23 ± 1	4 ± 1
Positive controls, +S9	Name	2-AA	2-AA	2-AA	2-AA	2-AA
	Concentrations (μg/plate)	1	2.5	5	2.5	2.5
		2235 ± 60	322 ± 15	406 ± 20	1732 ± 115	703 ± 41

 MMS = methylmethanesulfonate

SA = sodium azide

4-NQO = 4-nitroquinoline-N-oxide

9-AC = 9-aminoacridine

DM = daunomycine

2-AA = 2-aminoanthracene

SP = slight precipitate

 

Conclusions:

CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Analogue justification

No data on the genetic toxicity of Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) are available. The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Genetic toxicity (mutagenicity) in bacteria in vitro

CAS 22766-83-2

The in vitro genetic toxicity of 2-octyldodecyl myristate (CAS 22766-83-2) was assessed in a bacterial reverse mutation assay (Ames test) (WoE, 2007). The study was performed according to OECD guideline 471 and under GLP conditions. The plate incorporation method was applied in the first experiment and the preincubation method in the second experiment, using S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvrA pKM 101. All the strains were tested at concentrations up to and including the limit value of 5 µL/plate. No cytotoxicity was observed, with and without metabolic activation. The negative and positive controls were valid. The test substance did not induce an increase in reversions in the S. typhimurium and E.coli strains, with or without metabolic activation.

CAS 93803-87-3

The in vitro genetic toxicity of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was assessed in a bacterial reverse mutation assay (Ames test), performed according to OECD guideline 471 and in compliance with GLP (WoE, 1998). S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvrA were exposed to the test substance at concentrations up to and including 1000 µg/plate (TA 1535, TA 98 and TA 1537) and 5000 µg/plate (TA 100 and E.coli WP2 uvrA), using the plate incorporation method in two independent experiments. Precipitation was observed in the medium at 1000 µg/plate and above in all strains, with and without metabolic activation. The positive and solvent controls were shown to be valid. The test substance did not induce reversions in the S. typhimurium strains or E. coli strain, with or without metabolic activation.

Overall conclusion for genetic toxicity

There are no available studies on the genetic toxicity of the target substance.Therefore, analogue read-across from source substances was applied fromin vitro studies on gene mutations in bacterial cells. The results of the available in vitro studies were consistently negative. Based on the available data and following the analogue approach, Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) is not expected to be mutagenic in vitro.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

 

The available Ames tests on source substances fulfil the standard information requirements given in Annex VII of Regulation (EC) 1272/2008 and are suitable for classification. Based on the analogue read-across approach, there is no indication that the target substance induces genetic toxicity. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on mutagenicity and clastogenicity in mammalian cells/in vivo of read-across substances have been considered in the Annex VII dossier for Fatty acids, C18-unsaturated, 2-hexyldecyl ester.