Octan-1-ol, ethoxylated

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation in bacteria (OECD 471, Ames): negative with and without metabolic activation

Conclusion based on data obtained with octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) and considering all available data on gene mutation in bacteria in the Alcohol Ethoxylates (AE) category in a Weigh-of-Evidence approach.

 

No additional genetic toxicity information is required according to the respective tonnage band of octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1; 1 - 10 tpa, Annex VII information requirements). The following key information on genetic toxicity is available in the database of the AE category:

 

In vitro cytogenicity / chromosome aberration in mammalian cells: negative with and without metabolic activation

Conclusion based on all available data on cytogenicity / chromosome aberration in mammalian cells in the AE category considered in a Weigh-of-Evidence approach.

 

In vitro gene mutation in mammalian cells: negative with and without metabolic activation

Conclusion based on all available data on gene mutation in mammalian cells in the AE category considered in a Weigh-of-Evidence approach.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 - 21 Dec 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted 21 Jul 1997

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 30 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Version / remarks:

adopted Aug 1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japan MAFF

Version / remarks:

adopted 24 Nov 2000

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ICH S2(R1)

Version / remarks:

adopted Jun 2012

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Medicines and Healthcare Products Regulatory Agency, Department of Health, London, United Kingdom

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark

Target gene:

his operon

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital and beta-naphthoflavone

Test concentrations with justification for top dose:

1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation.
The maximum dose level of the test item was selected as the OECD 471 recommended dose level of 5000 µg/plate.

Vehicle / solvent:

- Vehicle/solvent used: DMSO
- Lot No. 184106
- Justification for choice of vehicle: The test item was immiscible in sterile distilled water at 50 mg/mL but was fully miscible in DMSO at the same concentration

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-aminoanthracene (2AA)

Remarks:

-S9: ENNG (2 µg/plate) f. WP2uvrA, (3 µg/plate) for TA100 + (5 µg/plate) f. TA1535; 9AA (80 µg/plate) f. TA1537; 4NQO (0.2 µg/plate) f. TA98 / +S9: 2AA (1 µg/plate) f. TA100, (2µg/plate) f. TA1535 + TA1537, (10µg/plate) f. WP2uvrA; BP (5 µg/plate) f. TA98

Details on test system and experimental conditions:

METHOD OF APPLICATION:
Initial mutation test: Plate incorporation
Confirmatory mutation test: Pre-incubation

DURATION
- Pre-incubation period: 20 min at 37 ± 3 °C
- Exposure duration: 48 to 72 h

NUMBER OF REPLICATIONS: triplicates each in two independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: observation of bacterial growth inhibition

Evaluation criteria:

A test item was considered mutagenic (positive) if the following criteria were met:
- a dose-related increase in mutant frequencies over the dose range tested
- a reproducible increase at one or more concentrations
- biological relevance against historical control ranges
- a fold increase greater than two times the concurrent vehicle control for TA100, TA98 and WP2uvrA or a three-fold increase for TA1535 and TA1537

A test item was considered non-mutagenic (negative) if the above mentioned criteria were not met.

Statistics:

Statistical significance was confirmed by using Dunnetts Regression Analysis (p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 µg/plate

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:

cytotoxicity

Remarks:

at 5000 µg/plate

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 in any experiment at any concentration
 
HISTORICAL CONTROL DATA: Results of positive and negative controls fell within historical control data range. Data are summarised in "Any other information on results incl. tables" Table 5.

Table 1: Test results - first experiment (plate incorporation test) without metabolic activation

Test Period		From: 07 December 2018					To: 10 December 2018
S9-Mix (-)	Dose Level Per Plate	Number of revertants (mean) +/- SD
		Base-pair substitution strains						Frameshift strains
		TA100		TA1535		WP2uvrA		TA98		TA1537
	Solvent Control (DMSO)	81 94 97	(91) 8.5#	13 12 18	(14) 3.2	28 28 38	(31) 5.8	30 24 27	(27) 3.0	18 23 9	(17) 7.1
	1.5 µg	98 90 105	(98) 7.5	21 17 18	(19) 2.1	41 21 26	(29) 10.4	17 24 15	(19) 4.7	11 27 12	(17) 9.0
	5 µg	98 98 107	(101) 5.2	12 9 28	(16) 10.2	34 26 33	(31) 4.4	17 34 25	(25) 8.5	12 14 17	(14) 2.5
	15 µg	86 109 99	(98) 11.5	16 9 14	(13) 3.6	48 25 21	(31) 14.6	25 32 28	(28) 3.5	28 26 6	(20) 12.2
	50 µg	91 115 112	(106) 13.1	9 8 14	(10) 3.2	30 32 40	(34) 5.3	28 19 31	(26) 6.2	11 14 9	(11) 2.5
	150 µg	64 92 95	(84) 17.1	15 14 15	(15) 0.6	26 21 32	(26) 5.5	24 16 18	(19) 4.2	13 18 24	(18) 5.5
	500 µg	90 106 86	(94) 10.6	16 18 13	(16) 2.5	27 30 29	(29) 1.5	11 19 17	(16) 4.2	12 21 22	(18) 5.5
	1500 µg	97 88 93	(93) 4.5	12 15 14	(14) 1.5	46 23 37	(35) 11.6	21 24 31	(25) 5.1	14 12 7	(11) 3.6
	5000 µg	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 V 0 V 0 V	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0
Positive controls S9-Mix (-)	Name DoseLevel No. of Revertants	ENNG		ENNG		ENNG		4NQO		9AA
		3 µg		5 µg		2 µg		0.2 µg		80 µg
		653 559 690	(634) 67.5	113 140 118	(124) 14.4	837 807 777	(807) 30.0	175 187 167	(176) 10.1	129 123 114	(122) 7.5

ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine

4NQO: 4-Nitroquinoline-1-oxide

9AA: 9-Aminoacridine

T: Toxic, no bacterial background lawn

V: Very weak bacterial backgroundlawn

#: Standard deviation

Table 2: Test results - first experiment (plate incorporation test) with metabolic activation

Test Period		From: 07 December 2018					To: 10 December 2018
S9-Mix (+)	Dose Level Per Plate	Number of revertants (mean) +/- SD
		Base-pair substitution strains						Frameshift strains
		TA100		TA1535		WP2uvrA		TA98		TA1537
	Solvent Control (DMSO)	108 101 115	(108) 7.0#	16 12 21	(16) 4.5	42 52 41	(45) 6.1	40 31 31	(34) 5.2	14 10 6	(10) 4.0
	1.5 µg	105 93 89	(96) 8.3	24 18 15	(19) 4.6	48 26 38	(37) 11.0	35 33 44	(37) 5.9	14 10 11	(12) 2.1
	5 µg	90 105 117	(104) 13.5	18 15 32	(22) 9.1	42 37 41	(40) 2.6	26 23 27	(25) 2.1	13 13 11	(12) 1.2
	15 µg	83 91 95	(90) 6.1	19 10 13	(14) 4.6	32 33 40	(35) 4.4	19 35 32	(29) 8.5	16 8 8	(11) 4.6
	50 µg	89 113 115	(106) 14.5	11 10 12	(11) 1.0	34 34 34	(34) 0.0	30 35 30	(32) 2.9	10 10 18	(13) 4.6
	150 µg	94 94 100	(96) 3.5	17 15 12	(15) 2.5	45 50 48	(48) 2.5	43 22 27	(31) 11.0	21 14 14	(16) 4.0
	500 µg	89 97 93	(93) 4.0	13 10 7	(10) 3.0	36 43 48	(42) 6.0	29 17 32	(26) 7.9	9 9 9	(9) 0.0
	1500 µg	97 102 98	(99) 2.6	12 15 14	(14) 1.5	44 49 34	(42) 7.6	36 24 41	(34) 8.7	11 12 12	(12) 0.6
	5000 µg	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 V 0 V 0 V	(0) 0.0	0 V 0 V 0 V	(0) 0.0	0 T 0 T 0 T	(0) 0.0
Positive controls S9-Mix (+)	Name DoseLevel No. of Revertants	2AA		2AA		2AA		BP		2AA
		1 µg		2 µg		10 µg		5 µg		2 µg
		1568 1502 1377	(1482) 97.0	261 244 247	(251) 9.1	202 217 270	(230) 35.7	192 197 199	(196) 3.6	270 286 308	(288) 19.1

BP: Benzo(a)pyrene

2AA: 2 -Aminoanthracene

T:Toxic, no bacterial background lawn

V:Very weak bacterial backgroundlawn

#: Standard deviation

Table 3: Test results - second experiment (pre-incubation test) without metabolic activation

Test Period		From: 18 December 2018					To: 21 December 2018
S9-Mix (-)	Dose Level Per Plate	Number of revertants (mean) +/- SD
		Base-pair substitution strains						Frameshift strains
		TA100		TA1535		WP2uvrA		TA98		TA1537
	Solvent Control (DMSO)	113 88 87	(96) 14.7#	18 14 17	(16) 2.1	32 16 26	(25) 8.1	26 34 23	(28) 5.7	14 8 16	(13) 4.2
	1.5 µg	111 92 124	(109) 16.1	25 14 28	(22) 7.4	22 24 28	(25) 3.1	28 15 18	(20) 6.8	8 8 6	(7) 1.2
	5 µg	76 124 116	(105) 25.7	16 17 17	(17) 0.6	31 21 18	(23) 6.8	23 25 27	(25) 2.0	3 8 13	(8) 5.0
	15 µg	114 143 121	(126) 15.1	16 16 17	(16) 0.6	19 23 20	(21) 2.1	23 34 28	(28) 5.5	12 10 13	(12) 1.5
	50 µg	104 147 119	(123) 21.8	16 16 22	(18) 3.5	17 16 31	(21) 8.4	23 30 34	(29) 5.6	8 13 13	(11) 2.9
	150 µg	101 100 112	(104) 6.7	18 13 16	(16) 2.5	21 23 19	(21) 2.0	33 21 23	(26) 6.4	11 5 11	(9) 3.5
	500 µg	98 S 100 S 102 S	(100) 2.0	20 28 13	(20) 7.5	23 26 26	(25) 1.7	24 17 27	(23) 5.1	7 10 2	(6) 4.0
	1500 µg	0 T 0 T 0 T	(0) 0.0	8 S 12 S 7 S	(9) 2.6	14 S 20 S 14 S	(16) 3.5	17 S 22 S 21 S	(20) 2.6	6 S 2 S 1 S	(3) 2.6
	5000 µg	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 V 0 V 0 V	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0
Positive controls S9-Mix (-)	Name DoseLevel No. of Revertants	ENNG		ENNG		ENNG		4NQO		9AA
		3 µg		5 µg		2 µg		0.2 µg		80 µg
		962 1054 1057	(1024) 54.0	1819 2356 1807	(1994) 313.6	901 911 989	(934) 48.2	286 251 236	(258) 25.7	260 246 418	(308) 95.5

ENNG:N-ethyl-N'-nitro-N-nitrosoguanidine

4NQO: 4-Nitroquinoline-1-oxide

9AA: 9-Aminoacridine

S: Sparse bacterial background lawn

T:Toxic, no bacterial background lawn

V:Very weak bacterial backgroundlawn

#: Standard deviation

Table 4: Test results - second experiment (pre-incubation test) with metabolic activation

Test Period		From: 18 December 2018					To: 21 December 2018
S9-Mix (+)	Dose Level Per Plate	Number of revertants (mean) +/- SD
		Base-pair substitution strains						Frameshift strains
		TA100		TA1535		WP2uvrA		TA98		TA1537
	Solvent Control (DMSO)	90 101 127	(106) 19.0#	15 10 30	(18) 10.4	37 24 30	(30) 6.5	28 30 26	(28) 2.0	11 7 14	(11) 3.5
	1.5 µg	122 108 124	(118) 8.7	22 15 21	(19) 3.8	31 27 27	(28) 2.3	22 18 28	(23) 5.0	7 9 9	(8) 1.2
	5 µg	90 113 99	(101) 11.6	30 11 15	(19) 10.0	26 32 32	(30) 3.5	32 37 28	(32) 4.5	12 5 10	(9) 3.6
	15 µg	124 97 115	(112) 13.7	17 12 9	(13) 4.0	38 24 31	(31) 7.0	30 38 37	(35) 4.4	12 12 9	(11) 1.7
	50 µg	134 126 114	(125) 10.1	13 12 19	(15) 3.8	23 24 39	(29) 9.0	31 26 34	(30) 4.0	12 16 6	(11) 5.0
	150 µg	110 130 129	(123) 11.3	9 19 10	(13) 5.5	28 37 37	(34) 5.2	34 27 28	(30) 3.8	12 10 7	(10) 2.5
	500 µg	114 115 112	(114) 1.5	22 8 15	(15) 7.0	26 16 16	(19) 5.8	22 25 26	(24) 2.1	16 7 8	(10) 4.9
	1500 µg	92 S 118 S 90 S	(100) 15.6	13 S 12 S 23 S	(16) 6.1	19 S 17 S 15 S	(17) 2.0	17 S 14 S 14 S	(15) 1.7	4 S 4 S 8 S	(5) 2.3
	5000 µg	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 V 0 V 0 V	(0) 0.0	0 T 0 T 0 T	(0) 0.0	0 T 0 T 0 T	(0) 0.0
Positive controls S9-Mix (+)	Name DoseLevel No. of Revertants	2AA		2AA		2AA		BP		2AA
		1 µg		2 µg		10 µg		5 µg		2 µg
		1486 1508 1576	(1523) 46.9	246 258 215	(240) 22.2	123 116 105	(115) 9.1	93 114 99	(102) 10.8	216 178 216	(203) 21.9

BP: Benzo(a)pyrene

2AA: 2 -Aminoanthracene

S: Sparse bacterial background lawn

T:Toxic, no bacterial background lawn

V:Very weak bacterial backgroundlawn

#: Standard deviation

Table 5: Historical control data

Strain

TA100

TA1535

WP2uvrA

TA98

TA1537

Metabolic activation

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

2017

Combined vehicle and untreated control

Mean ± SD

92 ± 14.4

92 ± 15.4

18 ± 6.5

17 ± 7.1

25 ± 7.0

31 ± 7.4

22 ± 6.9

26 ± 6.8

13 ± 3.4

14 ± 3.4

Range

61 - 148

63 - 148

8 - 39

8 - 40

7 - 64

13 52

11 - 54

14 - 59

4 - 25

5 - 32

2018

Mean ± SD

122 ± 18.8

125 ± 21.5

17 ± 4.2

14 ± 3.1

27 ± 5.5

36 ± 6.2

22 ± 4.5

27 ± 5.1

12 ± 3.3

13 ± 3.2

Range

67 - 170

64 - 187

7 - 33

9 - 28

11 - 44

20 - 53

11 - 41

15 - 30

5 - 25

3 - 22

2017

Positive control

Mean ± SD

769 ± 353.2

1415 ± 553.3

773 ± 556.3

160 ± 71.1

682 ± 231.3

257 ± 132.5

224 ± 62.9

191 ± 83.9

305 ± 132.9

380 ± 113.8

Range

260 - 2374

296 - 3165

83 - 3264

128 - 1035

96 - 1529

83 - 1491

99 - 437

64 - 924

86 - 1239

143 - 1022

2018

Mean ± SD

605 ± 213.6

1726 ± 528.7

653 ± 484.4

301 ± 57.2

706 ± 335.8

230 ± 74.8

212 ± 77.1

158 ± 49.3

274 ± 150.4

294 ± 86.8

Range

220 - 3525

422 - 3928

74 - 2601

113 - 481

111 - 1420

105 -697

97 - 461

79 - 342

86 - 833

116 - 542

Conclusions:

Under the tested conditions, the test compound was not mutagenic in any of the four tested S. typhimurium strains (TA 98, TA 100, TA 1535 and TA 1537), nor in the E. coli strain WP2uvrA with and without metabolic activation up to 5000 µg/plate.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro gene mutation in mammalian cells

Data on in vitro gene mutation in bacteria are available for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1)

The potential of octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) to induce gene mutation in bacteria was tested in a study conducted according to OECD guideline 471 under GLP conditions (Croda, 2019d). S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E. coli strain WP2uvrA were treated with the test item using both the Ames plate incorporation and pre-incubation methods at eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system. The dose range for experiment 1 (plate incorporation) was 1.5 to 5000 µg/plate. The experiment was repeated on a separate day (pre-incubation method) using fresh cultures of the bacterial strains and fresh test item formulations. The dose range was the same as in experiment 1. Eight test item concentrations per bacterial strain were selected in experiment 2 in order to achieve both four non toxic dose levels and the toxic limit. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range.  All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. 5000 µg/plate was the maximum dose level of the test item in the first experiment. The test item induced a visible reduction in the growth of the bacterial background lawns of all of the tester strains at 5000 µg/plate in both the presence and absence of metabolic activation, in the first mutation test. Based on the results of experiment 1, the same maximum dose level was employed in the second mutation test. In the second mutation test, the test item again induced a toxic response with weakened bacterial background lawns noted in the absence of S9-mix from 500 µg/plate (TA100) and 1500 µg/plate (remaining tester strains). In the presence of S9-mix weakened bacterial background lawns were noted to all of the tester strains from 1500 µg/plate. No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of metabolic activation (S9-mix) in experiments 1 and 2. There were no biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation in experiment 1. A minor statistical value was noted (TA1537 at 150 µg/plate in the presence of S9-mix). However, this response was within the in-house historical vehicle/untreated control range for the strain and was, therefore considered of no biological relevance. Similarly, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in experiment 2. The test substance was therefore considered to be non-mutagenic under the conditions of this test.

 

Studies in the AE category

Studies investigating in vitro gene mutation in bacteria are available for the following AE substances:

 

CAS No.	EC No.	Substance	Study protocol	Hazard conclusion
27252-75-1	500-058-1	Octan-1-ol, ethoxylated	OECD 471	Negative, with and without metabolic activation
68439-50-9	500-213-3	Alcohols, C12-14, ethoxylated	OECD 471	Negative, with and without metabolic activation
			Similar OECD 471	Negative, with and without metabolic activation
68439-49-6	939-518-5	Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO	OECD 471	Negative, with and without metabolic activation
9005-00-9	500-017-8	Octadecan-1-ol, ethoxylated	Similar OECD 471	Negative, with and without metabolic activation

 

Evaluation of gene mutation in bacteria as observed in studies

All available study results indicate a clear lack of mutagenic potential. No indication of an increase in revertant colony counts is observed in any study. Positive and vehicle control experiments yielded the expected results, demonstrating the adequacy of the test systems and metabolic activation systems. Based on all available data on in vitro gene mutation in bacteria in the AE category, it is predicted that the AE substances are not mutagenic in bacteria either in the presence or the absence of metabolic activation.

This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

 

In vitro cytogenicity / chromosome aberration in mammalian cells

Data on in vitro cytogenicity / chromosome aberration in mammalian cells are not required for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) in the respective tonnage band of the substance (1 - 10 tpa, Annex VII information requirements). Although legally not required, cytogenicity / chromosome aberration in mammalian cells is discussed here based on a study available in the database of the AE category. An adequate and reliable study investigating in vitro cytogenicity / chromosome aberration in mammalian cells within the AE category is available for alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5). The study demonstrates the lack of a clastogenic potential. Based on the study, it is concluded that the AE substances are not clastogenic in mammalian cells.

This evaluation is used for the hazard assessment and to conclude on the classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

 

In vitro gene mutation in mammalian cells

Data on in vitro gene mutation in mammalian cells are not required for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) in the respective tonnage band of the substance (1 - 10 tpa, Annex VII information requirements). Although legally not required, gene mutation in mammalian cells is discussed here based on a study available in the database of the AE category. An adequate and reliable study investigating in vitro gene mutation in mammalian cells within the AE category is available for alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5). The study demonstrates the lack of a mutagenic potential. Based on the study, it is concluded that the AE substances are not mutagenic in mammalian cells.

This evaluation is used for the hazard assessment and to conclude on the classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

Justification for classification or non-classification

The available data on genetic toxicity obtained with octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) and with other members of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.