Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Basic data given: scientifically acceptable study summary including result tabels; the test protocol can be viewed online. The quality of the NTP studies is generally good and accepted within the toxicological community. Neither Escherichia coli strain WP2 uvrA pKM101a nor S. typhimurium strain TA102 were employed in this study for the detection of oxidising mutagens and cross-linking agents.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1982
Reference Type:
publication
Title:
Mutagenicity Testing of Di(2-ethylhexyl)phthalate and Related Chemicals in Salmonella.
Author:
Zeiger E et al.
Year:
1985
Bibliographic source:
Environ. Mutagenesis 7: 213-232

Materials and methods

Principles of method if other than guideline:
The study was conducted according to the Standard NTP protocol (Preincubation Assay) which is comparable to the method described in the publication by Mortelsman and Zeiger (2000).

Mortelmans K, Zeiger E (2000). The Ames Salmonella/microsome mutagenicity assay. Mutat Res. 455(1-2): 29-60
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl acrylate
EC Number:
203-080-7
EC Name:
2-ethylhexyl acrylate
Cas Number:
103-11-7
Molecular formula:
C11H20O2
IUPAC Name:
2-ethylhexyl acrylate
Details on test material:
- Test substance: 2-ethylhexyl acrylate
- Chemical name: 2-propenoic acid, 2-ethylhexyl ester
- CAS No.: 103-11-7
- Analytical Purity: no data

Method

Target gene:
Histidin auxotrophy
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 from Aroclor 1254-induced male Sprague-Dawley rat and Syrian hamster liver
Test concentrations with justification for top dose:
0, 3.3, 10, 33, 100, 333, 1000, 3333, 10000 ug/plate
Vehicle / solvent:
dimethylsulfoxide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
dimethylsulfoxide
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Without activation: for TA1535 sodium azide, for TA100 sodium azide, for TA98 4-nitrophenylenediamine, for TA1537 9-aminoacridine; With activation: for all strains 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation


METABOLIC ACTIVATION
The test was conducted with and without metabolic activation. In this study metabolic activation enzymes and cofactors from Aroclor 1254 -induced male Sprague-Dawley rat and Syrian hamster liver were used. The percentage of S9 in the S9 mixture that was then added to cultures, was 10 %.

Results and discussion

Test results
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: TA1537: 333 ug/plate; TA1535 and TA100: 10000 ug/plate
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

TA1535:

			Mean number of revertants

Dose		No activation	10 % HLI	10 % RLI	
[ug/plate]	1st	2nd	1st	2nd	1st	2nd
--------------------------------------------------------------
0		13	30	13	23	8	19

100		11	23	12	18	13	21
333		9	22	11	15	9	20
1000		11	25	10	17	8	26
3333		13	20	8	14	9	24
10000		T	T	T	17	T	17

Pos. control	1071	1114	201	439	552	537
--------------------------------------------------------------

TA100:

			Mean number of revertants

Dose		No activation	10 % HLI	10 % RLI	
[ug/plate]	1st	2nd	1st	2nd	1st	2nd
--------------------------------------------------------------
0		130	166	159	238	164	193

100		138	171	118	255	134	227
333		126	163	103	223	165	202
1000		115	153	114	178	159	217
3333		112	152	108	183	176	193
10000		T	144	75	189	152	178

Pos. control	1632	358	1320	1321	906	2114
--------------------------------------------------------------

TA98:

			Mean number of revertants

Dose		No activation	10 % HLI	10 % RLI	
[ug/plate]	1st	2nd	1st	2nd	1st	2nd
--------------------------------------------------------------
0		19	15	28	33	27	21

100		15	15	31	33	21	28
333		14	14	26	33	25	28
1000		13	13	23	32	21	25
3333		16	10	21	31	17	25
10000		18	9	19	22	16	22

Pos. control	572	430	1058	924	1069	2119
--------------------------------------------------------------

TA1537:


			Mean number of revertants

Dose		No activation		10 % HLI	10 % RLI	
[ug/plate]	1st	2nd	3rd	1st	2nd	1st	2nd
---------------------------------------------------------------------
0		9	9	14	12	29	11	26

3.3			11	13
10			9	12
33			5	4
100		7	5	8	15	22	11	23
333		T	T	T	7	19	10	17
1000		T			7	15	13	19
3333		T			9	18	9	14
10000		T			6	19	8	14

Pos. control	199	730	1000	1341	413	382	196
---------------------------------------------------------------------
RLI: Rat Liver S9
HLI: Hamster Liver S9
s: slight toxicity
T: Toxic

Applicant's summary and conclusion

Conclusions:
negative