Registration Dossier
Registration Dossier
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EC number: 274-625-4 | CAS number: 70495-37-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The target substance is considered non-mutagenic based on the result of the source chemical, sodium 2-ethylhexyl sulfate, in a bacterial reverse mutation assay equivalent to OECD guideline 471.
Link to relevant study records
- 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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- An E. coli strain or S. typhimurium TA102 is lacking
- Principles of method if other than guideline:
- The test was performed according to OECD Guideline 471 using four S. typhimurium strains. A fifth strain (S. thypimurium TA 102, E. coli WP2 uvrA or WP2 uvrA (pKM101)) is lacking.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9
- Test concentrations with justification for top dose:
- +S9/-S9: 0, 100, 333, 1000, 3333 and 10000 µg/plate
- Vehicle / solvent:
- - Solvent used: water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-aminoanthracene (all strains) ; -S9: sodium azide (TA1535, TA100); 4-nitro-o-phenylenediamine (TA98); 9-aminoacridine (TA1537)
- Details on test system and experimental conditions:
- Approximately 10^8 bacteria were mixed with 0.5 mL of either 0.1M sodium phosphate buffer (pH 7.4) or S-9 mix (containing 10% S-9 fraction), and 50 or 100 µL of the test chemical or solvent, in each of three tubes. This mixture was incubated at 37 °C for 20 min, following which 2 mL of molten top agar containing a trace amount of biotin and a growth-limiting amount of histidine (0.05 mM each) was added. The mixture was then poured onto minimal agar plates and incubated at 37 °C for 48 hr, after which time histidine-revertant colonies were counted.
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
- Conclusions:
- Under the experimental conditions reported, the test item is considered non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The substance, sodium 2-ethylhexyl sulfate, was evaluated for mutagenicity in a Bacterial Reverse Mutation Test equivalent to OECD guideline 471. Salmonella typhimurium strains TA98, TA100, TA1535 and TA 1537 were exposed to the test item at concentrations of 0, 100, 333, 1000, 3333 and 10000 µg/plate with and without metabolic activation. Under the experimental conditions of this Bacterial Reverse Mutation Test, the test item is considered non-mutagenic in this bacterial reverse mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- JUSTIFCATION FOR THE ANALOGUE APPROACH
The read across is based on scenario 1 of the ECHA Read-Across-Assessment Framework document (RAAF, ECHA, 2017), i.e. the analogue approach for which the read-across hypothesis is based on transformation of target and source substance to common compounds. Both, target and source substance, are salts of 2-ethylhexyl sulfate, the target substance being the ammonium salt and the source substance being the sodium salt. Since both substances are highly soluble in aqueous media and dissociate into the same organic compound 2-ethylhexyl sulfate and the respective cation, the read-across according to RAAF scenario 1 is justified. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- valid
Referenceopen allclose all
Table 1: Results of the mutagenicity testing with Sodium 2-ethylhexyl sulfate
Dose |
TA100 |
TA1535 |
TA1537 |
TA98 |
||||
µg/Plate |
-S9 Mean (SEM) |
+S9 Mean (SEM) |
-S9 Mean (SEM) |
+S9 Mean (SEM) |
-S9 Mean (SEM) |
+S9 Mean (SEM) |
-S9 Mean (SEM) |
+S9 Mean (SEM) |
0 |
159 (7.4) |
158 (4.1) |
32 (3.0) |
16 (1.5) |
13 (0.7) |
16 (1.9) |
30 (1.5) |
44 (3.7) |
100 |
182 (5.7) |
145 (14.6) |
27 (1.9) |
13 (2.5) |
11 (1.0) |
18 (1.2) |
21 (1.5) |
43 (3.2) |
333 |
186 (0.7) |
136 (5.8) |
27 (4.5) |
15 (0.3) |
11 (3.6) |
19 (2.7) |
28 (1.5) |
39 (3.6) |
1000 |
181 (4.6) |
134 (4.4) |
23 (2.8) |
14 (6.0) |
9 (2.5) |
18 (2.0) |
35 (1.9) |
43 (3.8) |
3333 |
173 (7.0) |
137 (3.4) |
23 (3.2) |
14 (1.5) |
11 (2.2) |
18 (3.3) |
23 (3.6) |
34 (2.2) |
10000 |
113 s (6.7) |
116 (10.8) |
19 (0.9) |
15 (1.5) |
13 (0.7) |
9 (2.5) |
22 (2.7) |
37 (3.2) |
Positive control |
471 (17.5) |
1262 (54.6) |
359 (12.5) |
438 (30.3) |
215 (8.4) |
491 (60.8) |
815 (4.9) |
1031 (178.1) |
s: sligth clearing of background lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The substance, sodium 2-ethylhexyl sulfate,
was evaluated for mutagenicity in a Bacterial Reverse Mutation Test
equivalent to OECD guideline 471. Salmonella typhimurium strains TA98,
TA100, TA1535 and TA 1537 were exposed to the test item at
concentrations of 0, 100, 333, 1000, 3333 and 10000 µg/plate with and
without metabolic activation. Under the experimental conditions of this
Bacterial Reverse Mutation Test, the test item is considered
non-mutagenic in this bacterial reverse mutation assay.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on genetic toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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