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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-04-23 to 2012-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethylene bis(3-mercaptopropionate)
- EC Number:
- 245-044-3
- EC Name:
- Ethylene bis(3-mercaptopropionate)
- Cas Number:
- 22504-50-3
- Molecular formula:
- C8H14O4S2
- IUPAC Name:
- ethane-1,2-diyl bis(3-sulfanylpropanoate)
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- 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:
- Liver post-mitochondrial fraction (S9 fraction) from rats treated with Aroclor 1254. S9 was collected from 20 - 30 rats.
- Test concentrations with justification for top dose:
- 5000 µg GDMP/plate based on cytotoxicity (scarce background lawn and reduction of the number of revertants)
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h
SELECTION AGENT (mutation assays): his-free medium
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Plate incorporation test -without metabolic activation
S9 Mix |
Conc. (µg/ plate) |
Number of revertants (mean number of colonies per plate, n=3) |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1537 |
WP2 uvr A |
||
– |
0 |
40.7 |
157.3 |
22.0 |
5.0 |
5.7 |
29.3 |
– |
31.6 |
32.0 |
179.3 |
19.0 |
4.3 |
4.7 |
54.3 |
– |
100 |
37.7 |
140.0 |
19.3 |
2.3 |
3.3 |
53.0 |
– |
316 |
37.3 |
168.0 |
14.0 |
5.0 |
4.3 |
51.7 |
– |
1000 |
29.3 |
171.3 |
20.7 |
2.3 |
3.3 |
49.3 |
– |
3160 |
27.3 |
140.7 |
18.0 |
5.3 |
5.3 |
43.7 |
– |
5000 |
10.3# |
87.0# |
9.3# |
1.0# |
2.0# |
12.7# |
Pos controls |
Name |
2-NF |
NaN3 |
NaN3 |
9-AA |
2-NF |
NQO |
Conc. (µg/plate) |
10 |
10 |
10 |
100 |
10 |
5 |
|
No. of revertants per plate |
134.7 |
865.7 |
118.0 |
140.7 |
174.3 |
249.3 |
2-NF 2-Nitrofluorene
NQO 4-Nitroquinoline-1-oxide
9-AA 9-Aminoacridine
NaN3 Sodium azide
# scarce background lawn
Table 2: Plate incorporation test -with metabolic activation
S9 Mix |
Conc. (µg/ plate) |
Number of revertants (mean number of colonies per plate, n=3) |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1537 |
WP2 uvr A |
||
+ |
0 |
45.0 |
177.0 |
15.7 |
6.7 |
5.3 |
54.3 |
+ |
31.6 |
37.7 |
163.3 |
16.0 |
4.7 |
6.7 |
42.3 |
+ |
100 |
39.7 |
153.7 |
14.0 |
2.0 |
6.3 |
52.7 |
+ |
316 |
35.3 |
161.0 |
19.7 |
5.0 |
5.3 |
50.7 |
+ |
1000 |
26.7 |
166.3 |
22.3 |
1.7 |
4.3 |
53.0 |
+ |
3160 |
35.3 |
161.3 |
18.0 |
3.7 |
4.3 |
52.0 |
+ |
5000 |
15.0# |
91.3# |
7.7# |
1.0# |
1.7# |
16.3# |
Pos controls |
Name |
BaP |
NaN3 |
NaN3 |
9-AA |
2-NF |
NQO |
Conc. (µg/plate) |
5 |
2 |
2 |
5 |
5 |
2 |
|
No. of revertants per plate |
120.7 |
869.0 |
125.7 |
142.7 |
170.3 |
211.0 |
BaP Benzo[a]pyrene
2-AA 2-Aminoanthracene
# scarce background lawn
Table 3: Pre-incubation test -without metabolic activation
S9 Mix |
Conc. (µg/ plate) |
Number of revertants (mean number of colonies per plate, n=3) |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1537 |
WP2 uvr A |
||
– |
0 |
35.3 |
153.7 |
17.7 |
4.7 |
5.7 |
47.0 |
– |
31.6 |
33.3 |
153.7 |
16.0 |
6.3 |
5.3 |
47.7 |
– |
100 |
23.7 |
155.0 |
15.7 |
5.0 |
5.3 |
51.3 |
– |
316 |
35.7 |
1296.7 |
17.7 |
5.3 |
5.0 |
51.7 |
– |
1000 |
24.7 |
137.0 |
26.7 |
5.7 |
6.3 |
48.0 |
– |
3160 |
4.07 |
14137 |
22.7 |
5.0 |
5.7 |
43.7 |
– |
5000 |
9.3# |
59.0# |
4.3# |
1.0# |
1.7# |
9.3# |
Pos controls |
Name |
2-NF |
NaN3 |
NaN3 |
9-AA |
2-NF |
NQO |
Conc. (µg/plate) |
10 |
10 |
10 |
100 |
10 |
5 |
|
No. of revertants per plate |
175.7 |
945.3 |
127.7 |
127.0 |
230.1 |
224.7 |
2-NF 2-Nitrofluorene
NQO 4-Nitroquinoline-1-oxide
9-AA 9-Aminoacridine
NaN3 Sodium azide
# scarce background lawn
Table 4: Pre-incubation test -with metabolic activation
S9 Mix |
Conc. (µg/ plate) |
Number of revertants (mean number of colonies per plate, n=3) |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1537 |
WP2 uvr A |
||
+ |
0 |
36.7 |
161.7 |
16.7 |
2.7 |
4.7 |
56.0 |
+ |
31.6 |
27.7 |
148.3 |
19.7 |
6.0 |
7.0 |
39.0 |
+ |
100 |
28.0 |
141.0 |
18.7 |
4.7 |
5.0 |
45.7 |
+ |
316 |
35.3 |
163.7 |
11.7 |
5.7 |
4.7 |
30.7 |
+ |
1000 |
23.7 |
152.0 |
19.7 |
4.7 |
4.7 |
50.3 |
+ |
3160 |
22.7 |
168.7 |
15.0 |
3.0 |
5.3 |
46.3 |
+ |
5000 |
10.7# |
43.7# |
6.7# |
1.0# |
1.7# |
8.3# |
Pos controls |
Name |
BaP |
NaN3 |
NaN3 |
9-AA |
2-NF |
NQO |
Conc. (µg/plate) |
5 |
2 |
2 |
5 |
5 |
2 |
|
No. of revertants per plate |
178.0 |
980.7 |
173.3 |
113.0 |
227.7 |
255.3 |
BaP Benzo[a]pyrene
2-AA 2-Aminoanthracene
# scarce background lawn
Applicant's summary and conclusion
- Conclusions:
- GDMP is negative in the Ames test, with and without metabolic activation.
- Executive summary:
GDMP was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and in the Escherichia coli strain WP2 uvr A in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
GDMP was completely dissolved in dimethylsulfoxide (DMSO). The vehicle DMSO served as the negative control.
Preliminary test
GDMP was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA 100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 5000 μg GDMP/plate.
Hence, 5000 μg GDMP/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test, respectively.
Main study
Six concentrations ranging from 31.6 to 5000 μg GDMP/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 5000 μg GDMP/plate, in all Salmonella typhimurium strains and in the Escherichia coli strain WP2 uvr A.
No mutagenic effect (no increase in revertant colony numbers as compared with control counts) was observed for GDMP, tested up to a cytotoxic concentration of 5000 μg/plate, in the Salmonella typhimurium and in the Escherichia coli test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test).
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