Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.

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:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, with the exception that no cross linking strain was used. Read across to the registered substance is considered scientifically justified

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

The toxicity of behenyl alcohol: I. Genotoxicity and subchronic toxicity in rats and dogs

Author:

Iglesias G, J J Hlywka, J E Berg, M H Khalil, L E Pope and D Tamarkin

Year:

2002

Bibliographic source:

Regulatory Tox. and Pharm. 36, 69-79 2002a

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(no TA102 or E. coli WP2 uvrA; 2-aminoanthracene only positive control with metabolic activation)

Principles of method if other than guideline:

Well-conducted study according to a protocol very similar to OECD guideline 471

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Docosan-1-ol

EC Number:

211-546-6

EC Name:

Docosan-1-ol

Cas Number:

661-19-8

Molecular formula:

C22H46O

IUPAC Name:

docosan-1-ol

Details on test material:

- Name of test material (as cited in study report): behenyl alcohol
- Substance type: colourless, waxy solid
- Physical state: solid
- Analytical purity: no data, but for repeated dose toxicity (oral) studies reported in same publication, 98%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data, but for repeated dose toxicity (oral) studies, obtained from Condea, Germany
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other:
- Melting point: 70 deg C
- Soluble in: ethanol and chloroform
- Insoluble in: water

Method

Target gene:

histidine

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

liver microsomal fractions from male rats prepared by "established methods"

Test concentrations with justification for top dose:

10, 100, 333, 667, and 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA100, TA1535 without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-O-phenylenediamine

Remarks:

TA98, TA1537, TA1538 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: aminoanthracene

Remarks:

all strains with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: none
- Exposure duration: no data

NUMBER OF REPLICATES:
- two independent experiments, both with and without metabolic activation
- each concentration (including controls) tested in triplicate

DETERMINATION OF CYTOTOXICITY
- Method: no data

Evaluation criteria:

To be considered positive in TA100, >=2x increase in revertants over spontaneous rate; in TA98, TA1535, TA1537 and TA1538, >=3x increase; alternatively a concentration-dependent increase irrespective of 2- or 3-fold increase

Statistics:

none

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: not determined, but number of revertants reduced in TA 98 at 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: not determined, but number of revertants not reduced at 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data

RANGE-FINDING/SCREENING STUDIES: yes, no data presented

COMPARISON WITH HISTORICAL CONTROL DATA: no

ADDITIONAL INFORMATION ON CYTOTOXICITY: none

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1 Revertants per plate (mean of 3 plates)

Concentration µg/plate	TA 98		TA100		TA1535		TA1537		TA1538
	- S9	+ S9	- S9	+ S9	- S9	+ S9	- S9	+ S9	- S9	+ S9
Negative control	15.3	17.0	82.3	833.7	5.7	8.0	5.0	4.0	14.3	16.7
0*	15.3	15.7	83.3	77.3	8.3	8.3	7.0	5.0	14.7	15.0
10.0	14.0	19.0	70.7	80.3	10.7	9.7	3.0	5.0	14.3	14.0
100.0	9.3	15.3	85.0	82.0	7.7	9.0	4.0	4.3	14.7	15.7
333.3	11.7	15.7	80.0	79.7	8.0	12.3	4.7	5.0	15.0	15.3
666.6	12.0	12.7	74.0	82.3	8.3	6.3	4.3	5.3	14.0	15.3
1000	6.7	8.0	76.0	86.3	4.7	3.3	3.7	5.0	13.7	14.7
Positive control	1573	2337.7	1158	2414	601.7	345	109.7	85.3	1980	495.7

* Solvent control with

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In a valid and reliable study, behenyl alcohol (C22) did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at concentrations up to and including 1000 µg/plate. It is concluded that the test substance is negative for mutagenicity in bacteria under the conditions of the test.