Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-802-0 | CAS number: 110-77-0
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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May 16 1986 to June 6 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to a protocol that was similar to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that the range of strains does not comply with the current guideline. Read across to the registered substance is considered scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-dithiobisethanol
- EC Number:
- 217-576-6
- EC Name:
- 2,2'-dithiobisethanol
- Cas Number:
- 1892-29-1
- IUPAC Name:
- 2,2'-disulfanediyldiethanol
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, 100, 1535, 1537, 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 0.050 - 10.000 µl/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: based on solubility of test substance
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535 without metabolic activation
Migrated to IUCLID6: 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 and YA 1538 without metabolic activation
Migrated to IUCLID6: 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: quinacrine mustard 5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine 2.5 µg/plate
- Remarks:
- all strains with metabolic activation
- Details on test system and experimental conditions:
- Activation: S9 mix contained 10% S9 and cofactors glucose-6-phosphate and NADP; 0.5 ml were added to agar, test substance and indicator organisms to a total volume of 2.75 ml.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Fixation time (start of exposure up to fixation or harvest of cells): 2 days
SELECTION AGENT (mutation assays): histidine deficient medium
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: condition of background lawn - Evaluation criteria:
- A positive result is a reproducible dose-related increase in the mean number of revertants relative to solvent control.
- Statistics:
- No statistical methods employed.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, 100, 1535, 1537, 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5 µl/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no information
- Effects of osmolality: no information
- Evaporation from medium: no information
- Water solubility: no information
- Precipitation: no information
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: test concentrations were based on the preliminary range-finding study
COMPARISON WITH HISTORICAL CONTROL DATA: The solvent controls were within the range of the historical controls
ADDITIONAL INFORMATION ON CYTOTOXICITY: test material was toxic at 4.69 µl/plate and above in the preliminary toxicity test, as evidenced by the reduced number of revertants and the clearing of the background lawn on the minimal media plates. - 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 µl/plate |
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
0* |
29.0 |
15.0 |
9.0 |
10.0 |
13.0 |
17.3 |
26.3 |
29.3 |
171.3 |
138.7 |
0.050 |
27.3 |
14.7 |
10.3 |
11.7 |
11.3 |
20.7 |
25.3 |
37.3 |
175.3 |
150.3 |
0.100 |
22.7 |
13.0 |
6.7 |
7.0 |
9.3 |
17.7 |
21.3 |
28.7 |
169.3 |
167.3 |
0.250 |
21.0 |
12.7 |
8.0 |
8.3 |
10.3 |
15.7 |
20.3 |
31.0 |
179.3 |
157.0 |
0.500 |
23.0 |
14.7 |
7.3 |
11.0 |
9.3 |
14.0 |
23.3 |
33.7 |
182.7 |
152.3 |
1.000 |
19.3 |
14.7 |
7.0 |
11.0 |
10.3 |
16.7 |
19.0 |
32.0 |
166.7 |
155.0 |
2.500 |
16.0 |
13.3 |
8.3 |
4.3 |
7.0 |
9.3 |
18.7 |
30.0 |
190.3 |
152.3 |
5.000 |
9.0 |
6.3 |
6.3 |
4.3 |
1.7 |
1.0 |
12.7 |
13.0 |
126.7 |
91.7 |
10.000 |
0.0 |
0.0 |
3.0 |
0.0 |
0.0 |
0.0 |
0.0 |
.0. |
37 |
0.0 |
Positive control |
1459.3 |
154.7 |
1431.3 |
159.0 |
1330.3 |
136.3 |
986.3 |
1535.0 |
1542.0 |
1456.0 |
*Solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
2,2'-dithiobisethanol has been tested according to a protocol that is similar to OECD 471 and under GLP. The test substance did not induce an increase in the number revertants in any of strains tested, either with or without activation. It is concluded that 2,2'-dithiobisethanol is negative for induction of mutations in bacteria under the conditions of the test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
