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EC number: 226-159-8 | CAS number: 5306-85-4
- 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:
- 09 - 23 May 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- yes
- Remarks:
- E.coli and/or TA 102 tester strain were not included in the study; cytotoxicity/precipitation was not determined.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- EC Number:
- 226-159-8
- EC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- Cas Number:
- 5306-85-4
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: All TA strains carry a mutation of the uvr B gene coding for the DNA excision repair system (uvrB) and the deep rough mutation (rfa), TA100 and TA98 contain the R-factor plasmid (pkM101) to detect weak mutagens.
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: All TA strains carry a mutation of the uvr B gene coding for the DNA excision repair system (uvrB) and the deep rough mutation (rfa), TA100 and TA98 contain the R-factor plasmid (pkM101) to detect weak mutagens.
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- Experiment I
- 1.6, 8, 40, 200, 1000 and 5000 µg/plate (with and without metabolic activation)
Experiment II
- 1.6, 8, 40, 200, 1000 and 5000 µg/plate (with and without metabolic activation)
Experiment III
- 1.6, 8, 40, 200, 1000 and 5000 µg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Acridine Mutagen ICR191 (AM), 2-Aminoanthracene (2AA), Daunorubicin HCl (DR), 4-Nitro-o-phenylene diamine (4NPD), N-Methyl-N´-nitro-N-nitrosoguanidine (MNNG)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3 plates for each test concentration, 5 plates for negative controls, 2 plates for each positive control - Evaluation criteria:
- A positive response in an experiment is achieved when a two-fold or greater increase in the mean number of revertant colonies per test plate (over and above that observed for the solvent control plates) is obtained at at least one dose level. A second criterion for a positive result is the observation of a statistically significant dose-related increase in the number of revertants. In either case, the observed effect should be reproducible.
- Statistics:
- Mean values (colony count/plate) and standard deviation were calculated. An assessment of the statistical significance was carried out using a one-tailed Student´s t-test. The corresponding probability for each dose level was determined from a t-table using the appropriate degrees of freedom.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: No information is given, if a range-finding study was performed. In addition, cytotoxicity was neither examined in a previous study nor during the course of the study.
COMPARISON WITH HISTORICAL CONTROL DATA: No information is available for historical control data.
Any other information on results incl. tables
Table 1: Test Results - Experiment I (Plate Incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
||
– |
0 |
19.0 ± 2.7 |
114.0 ± 16.2 |
10.0 ± 4.0 |
5.0 ± 1.9 |
15.2 ± 4.1 |
– |
1.6 |
21.0 ± 1.7 |
101.7 ± 16.3 |
14.0 ± 0.0 |
6.7 ± 3.1 |
14.7 ± 3.5 |
– |
8 |
20.7 ± 1.2 |
109.0 ± 3.6 |
12.0 ± 0.0 |
5.0 ± 2.0 |
16.7 ± 2.1 |
– |
40 |
18.7 ± 1.5 |
96.0 ± 15.6 |
10.0 ± 1.4 |
6.7 ± 1.2 |
16.3 ± 3.5 |
– |
200 |
18.7 ± 4.0 |
120.0 ± 16.1 |
C |
5.7 ± 3.8 |
17.3 ± 4.6 |
– |
1000 |
20.7 ± 2.1 |
108.7 ± 13.6 |
C |
7.0 ± 2.6 |
17.3 ± 1.5 |
– |
5000 |
26.0 ± 6.9 |
114.3 ± 12.7 |
18.3 ± 3.1 |
6.0 ± 1.0 |
17.0 ± 4.0 |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
AM |
4NPD |
DR |
Concentrations (μg/plate) |
1 |
1 |
1 |
1 |
0.2 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
59.0 ± 26.9 |
215.0 ± 2.8 |
90.0 ± 0.0 |
49.5 ± 0.7 |
298.0 ± 24.0 |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
0.5 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
854.0 ± 69.3 |
825.0 ± 21.2 |
125. 0 ± 12.7 |
100.5 ± 19.1 |
700.5 ± 3.5 |
|
Concentrations (μg/plate) |
5 |
5 |
- |
5 |
1 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
2285.0 ± 257.4 |
2160.5 ± 85.6 |
- |
167.0 ± 25.5 |
1019.5 ± 64.3 |
|
+ |
0 |
14.0 ± 2.2 |
127.2 ± 18.9 |
15.4 ± 3.2 |
8.4 ± 3.8 |
16.0 ± 5.1 |
+ |
1.6 |
17.0 ± 3.6 |
132.3 ± 17.2 |
15.0 ± 2.0 |
7.0 ± 2.6 |
17.7 ± 5.7 |
+ |
8 |
15.3 ± 4.0 |
134.3 ± 7.4 |
15.0 ± 0.0 |
7.3 ± 1.5 |
20.7 ± 3.5 |
+ |
40 |
15.7 ± 4.6 |
132.3 ± 15.3 |
13.3 ± 3.5 |
7.3 ± 1.2 |
15.0 ± 3.6 |
+ |
200 |
22.3 ± 4.7 |
123.3 ± 11.6 |
9.0 ± 4.4 |
7.0 ± 1.0 |
16.0 ± 1.7 |
+ |
1000 |
16.3 ± 1.5 |
119.7 ± 8.5 |
18.5 ± 4.9 |
8.0 ± 1.7 |
15.3 ± 0.6 |
+ |
5000 |
18.3 ± 2.1 |
130.7 ± 1.2 |
8.0 ± 0.0 |
9.0 ± 4.0 |
13.0 ± 2.0 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
0.5 |
0.2 |
0.5 |
0.2 |
0.2 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
57.5 ± 2.1 |
282.0 ± 17.0 |
33.0 ± 0.0 |
4.5 ± 2.1 |
132.5 ± 19.1 |
|
Concentrations (μg/plate) |
1 |
0.5 |
1 |
0.5 |
0.5 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
78.0 ± 5.7 |
479.0 ± 137.2 |
66.5 ± 16.3 |
4.0 ± 0.0 |
353.5 ± 12.0 |
|
Concentrations (μg/plate) |
2 |
1 |
2 |
1 |
1 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
125.5 ± 26.2 |
953.0 ± 7.1 |
184.0 ± 1.4 |
6.0 ± 1.4 |
730.5 ± 91.2 |
2AA: 2-aminoanthracene
MNNG: N-methyl-N´-nitro-N-nitrosoguanidine
DR: Daunorubicin
AM: Acridine mutagen
4NPD: 4-nitro-o-phenylenediamine
C: Contaminated
Table 2: Test Results - Experiment II (Plate Incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
||
– |
0 |
13.0 ± 4.0 |
103.6 ± 20.4 |
10.5 ± 2.1 |
8.6 ± 3.4 |
12.8 ± 3.6 |
– |
1.6 |
13.7 ± 4.6 |
107.0 ± 16.5 |
7.0 ± 1.0 |
12.0 ± 1.0 |
14.0 ± 3.0 |
– |
8 |
12.3 ± 4.9 |
118.7 ± 9.1 |
6.5 ± 0.7 |
8.0 ± 1.0 |
11.7 ± 2.9 |
– |
40 |
11.3 ± 3.5 |
121.3 ± 13.7 |
8.7 ± 0.6 |
7.7 ± 2.1 |
13.3 ± 1.5 |
– |
200 |
14.0 ± 2.6 |
122.3 ± 4.5 |
5.0 ± 0.0 |
7.3 ± 3.1 |
11.3 ± 0.6 |
– |
1000 |
11.7 ± 2.1 |
124.0 ± 26.6 |
6.7 ± 2.1 |
6.0 ± 1.7 |
14.3 ± 3.5 |
– |
5000 |
12.0 ± 1.0 |
118.7 ± 16.1 |
6.5 ± 0.7 |
9.7 ± 3.2 |
13.7 ± 4.2 |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
AM |
4NPD |
DR |
Concentrations (μg/plate) |
1 |
1 |
0.5 |
1 |
0.2 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
133.0 ± 62.2 |
328.0 ± 89.1 |
49.0 ± 2.8 |
52.0 ± 15.6 |
323.5 ± 68.6 |
|
Concentrations (μg/plate) |
2 |
2 |
1 |
2 |
0.5 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
901.5 ± 252.4 |
1326.5 ± 26.2 |
70.0 ± 2.8 |
88.0 ± 2.8 |
770.0 ± 87.7 |
|
Concentrations (μg/plate) |
5 |
5 |
2 |
5 |
1 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
1672.0 ± 32.5 |
1920.0 ± 83.4 |
127.0 ± 14.1 |
200.0 ± 46.7 |
809.5 ± 67.2 |
|
+ |
0 |
18.8 ± 5.1 |
125.4 ± 11.8 |
11.0 ± 5.0 |
10.2 ± 1.1 |
17.0 ± 1.9 |
+ |
1.6 |
18.7 ± 2.1 |
128.7 ± 4.5 |
11.3 ± 1.2 |
12.3 ± 5.7 |
18.0 ± 1.7 |
+ |
8 |
20.7 ± 3.1 |
142.0 ± 9.5 |
8.3 ± 4.2 |
13.0 ± 0.0 |
19.7 ± 4.7 |
+ |
40 |
15.0 ± 1.7 |
128.0 ± 21.0 |
10.0 ± 0.0 |
9.3 ± 1.5 |
17.0 ± 3.0 |
+ |
200 |
18.7 ± 3.1 |
124.3 ± 11.1 |
9.3 ± 1.5 |
9.0 ± 1.0 |
12.0 ± 1.0 |
+ |
1000 |
15.0 ± 1.0 |
127.7 ± 4.2 |
11.7 ± 2.5 |
9.3 ± 0.6 |
17.3 ± 3.8 |
+ |
5000 |
22.0 ± 4.0 |
135.3 ± 9.5 |
8.5 ± 2.1 |
10.7 ± 3.2 |
15.3 ± 3.5 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
0.5 |
0.2 |
1 |
0.2 |
0.2 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
48.0 ± 8.5 |
242.0 ± 35.4 |
51.0 ± 7.1 |
78.5 ± 2.1 |
78.0 ± 4.2 |
|
Concentrations (μg/plate) |
1 |
0.5 |
2 |
0.5 |
0.5 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
70.5 ± 12.0 |
442.0 ± 60.8 |
271.5 ± 112.4 |
330.5 ± 103.9 |
183.5 ± 17.7 |
|
Concentrations (μg/plate) |
2 |
1 |
- |
1 |
1 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
114.5 ± 0.7 |
749.0 ± 282.8 |
- |
487.5 ± 224.2 |
510.5 ± 38.9 |
2AA: 2-aminoanthracene
MNNG: N-methyl-N´-nitro-N-nitrosoguanidine
DR: Daunorubicin
AM: Acridine mutagen
4NPD: 4-nitro-o-phenylenediamine
Table 3: Test Results - Experiment III (Plate Incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
|
Frameshift type |
|||
TA 1537 (-S9-Mix) |
TA 1538 (+ S9-Mix) |
||
–/+ |
0 |
10.8 ± 1.9 |
7.0 ± 1.2 |
–/+ |
1.6 |
9.0 ± 1.7 |
9.0 ± 3.0 |
–/+ |
8 |
10.0 ± 4.6 |
6.7 ± 1.5 |
–/+ |
40 |
11.3 ± 2.1 |
9.7 ± 3.2 |
–/+ |
200 |
8.0 ± 4.4 |
8.0 ± 1.7 |
–/+ |
1000 |
12.7 ± 1.5 |
10.0 ± 2.6 |
–/+ |
5000 |
8.7 ± 4.0 |
11.0 ± 4.0 |
Positive controls, –S9 |
Name |
AM |
2AA |
Concentrations (μg/plate) |
0.5 |
0.2 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
67.0 ± 9.9 |
70.5 ± 2.1 |
|
Concentrations (μg/plate) |
1 |
0.5 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
82.5 ± 6.4 |
141.0 ± 8.5 |
|
Concentrations (μg/plate) |
2 |
1 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
123.0 ± 2.8 |
402.0 ± 1.4 |
AM: Acridine mutagen
2AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) tested with and without metabolic activation.
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