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EC number: 700-672-1 | CAS number: 70226-26-5
- 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
- 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:
- 31 Jan - 10 Feb 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Only five S. typhimurium strains and neither the tester strain TA102 nor an additional E. Coli strain were included in the testing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no E. coli or TA102 was included in the testing.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,3-dihydroxypropyl laurate
- EC Number:
- 205-526-6
- EC Name:
- 2,3-dihydroxypropyl laurate
- Cas Number:
- 142-18-7
- Molecular formula:
- C15H30O4
- IUPAC Name:
- 2,3-dihydroxypropyl laurate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Substance class: surfactant, glyceryl laurate
- Chemical denomination: lauric acid monoglyceride
- Physical state: white solid
- Analytical purity: 100% (active substance)
- Purity test date: 17 Nov 1994
- Lot/batch No.: MD 5094081
- Expiration date of the lot/batch: Mar 1995
- Stability: 12 months (pure)
- Stability in solvent: not given
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- his operon
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
Second experiment: 6.25, 12.5, 25, 50 and 100 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidistilled water (0.1 mL/plate)
- Justification for choice of solvent/vehicle: According to solubility properties which were tested prelininary before start of the study, the suspension medium Tween 80/bidist. water was chosen.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated fresh cell suspensions
- Negative solvent / vehicle controls:
- yes
- Remarks:
- suspension medium Tween 80/bidist. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538; with S9: 2 aminoanthracene (2.5 or 5 µg/plate) for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: clearing or diminution of the background lawn - Evaluation criteria:
- A combination of the following criteria was considered as a positive result:
The plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls.
The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range (see Table 1 under "Any other information on materials and methods incl. tables").
As a rule, the positive control showed mutation rates exceeding the control values of TA100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.03.
- At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.
Reproducibility:
If the test substance induces reverse mutations in only one test, and if this effect cannot be reproduced in one or several repeated tests, the initially positive test data will lose their significance. The criteria for interpretation specified here do not apply absolutely. Other aspects in connection with this in vitro test system may as well be taken into account for the final assessment of the test substance. - Statistics:
- Mean values and standard deviation were calculated.
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:
- cytotoxicity
- Remarks:
- from 40 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitations were not noted.
COMPARISON WITH HISTORICAL CONTROL DATA: number of revertants in the negative and vehicle controls (with and without S9) were all within the characteristic spontaneous mutation ranges of the test batches presented in Table 1 under "any other information on materials and methods incl. tables".
ADDITIONAL INFORMATION ON CYTOTOXICITY:
First experiment:
The background lawn was reduced or completely cleared in:
TA100 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA1535 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA1537 from 40 µg/plate (-S9 and +S9)
TA1538 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA98 from 200 µg/plate (+S9 and +S9)
Second experiment:
The background lawn was reduced or completely cleared in:
TA100 from 50 µg/plate (-S9) and from 100 µg/plate (+S9)
TA1535 from 100 µg/plate (-S9 and +S9)
TA1537 from 50 µg/plate (-S9 and +S9)
TA1538 from 50 µg/plate (-S9 and +S9)
TA98 from 100 µg/plate (+S9 and +S9) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2. Results of Experiment I.
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
TA 100 |
TA1535 |
TA1537 |
TA1538 |
TA98 |
– |
Untreated |
168 |
20 |
13 |
27 |
28 |
– |
Vehicle |
134 |
17 |
14 |
28 |
32 |
– |
8 |
119 |
16 |
9 |
29 |
28 |
– |
40 |
87 |
10 |
4 |
T |
24 |
– |
200 |
T |
T |
T |
T |
20 |
– |
1000 |
T |
T |
T |
T |
T |
– |
5000 |
T |
T |
T |
T |
T |
Positive controls, –S9 |
Name |
Sodium azide |
Sodium azide |
9-AA |
4-NOPD |
4-NOPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3) |
474 |
455 |
604 |
1675 |
1359 |
|
+ |
Untreated |
152 |
22 |
17 |
23 |
51 |
+ |
Vehicle |
159 |
18 |
13 |
31 |
38 |
+ |
8 |
126 |
18 |
12 |
23 |
32 |
+ |
40 |
132 |
13 |
12 |
25 |
30 |
+ |
200 |
96 |
15 |
5 |
23 |
27 |
+ |
1000 |
45 |
T |
T |
8 |
10 |
+ |
5000 |
20 |
T |
T |
T |
T |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3) |
1562 |
183 |
87 |
1339 |
940 |
2-AA = 2-aminoanthracene
9-AA = 9-aminoacridine
4-NOPD = 4-nitro-o-phenylendiamine
T = toxic
Table 3. Results of Experiment II.
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
TA 100 |
TA1535 |
TA1537 |
TA1538 |
TA98 |
– |
Untreated |
121 |
13 |
12 |
28 |
24 |
– |
Vehicle |
141 |
13 |
9 |
24 |
31 |
– |
6.25 |
135 |
20 |
14 |
26 |
26 |
– |
12.5 |
137 |
19 |
11 |
34 |
26 |
– |
25 |
112 |
12 |
7 |
30 |
29 |
– |
50 |
79 |
13 |
8 |
T |
28 |
– |
100 |
T |
T |
T |
T |
20 |
Positive controls, –S9 |
Name |
Sodium azide |
Sodium azide |
9-AA |
4-NOPD |
4-NOPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3) |
612 |
518 |
457 |
1741 |
1449 |
|
+ |
Untreated |
128 |
14 |
12 |
26 |
38 |
+ |
Vehicle |
129 |
16 |
17 |
27 |
26 |
+ |
6.25 |
135 |
14 |
14 |
27 |
42 |
+ |
12.5 |
114 |
13 |
12 |
30 |
27 |
+ |
25 |
129 |
17 |
13 |
28 |
26 |
+ |
50 |
119 |
15 |
8 |
21 |
28 |
+ |
100 |
111 |
15 |
12 |
T |
23 |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3) |
1591 |
166 |
143 |
1499 |
780 |
2-AA = 2-aminoanthracene
9-AA = 9-aminoacridine
4-NOPD = 4-nitro-o-phenylendiamine
T = toxic
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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