Registration Dossier
Registration Dossier
Diss Factsheets
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: 701-197-2 | 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 mammalian cells
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented publication, which meets basic scientific principles and was performed similar to OECD guideline 476, performed i.a. on the read-across substances glycidol und butylglycidyl ether
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of alkyl glycidyl ethers in three short-term assays
- Author:
- Thompson, E.D., Coppinger, W.J., Piper, C.E., McCarroll, N., Oberly, T.J., Robinson, D.
- Year:
- 1 981
- Bibliographic source:
- Mutation Research, 90 (1981) 213-231
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not applicable
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,3-epoxypropan-1-ol
- EC Number:
- 209-128-3
- EC Name:
- 2,3-epoxypropan-1-ol
- Cas Number:
- 556-52-5
- Molecular formula:
- C3H6O2
- IUPAC Name:
- oxiran-2-ylmethanol
- Reference substance name:
- Glycidol
- IUPAC Name:
- Glycidol
- Reference substance name:
- Butyl 2,3-epoxypropyl ether
- EC Number:
- 219-376-4
- EC Name:
- Butyl 2,3-epoxypropyl ether
- Cas Number:
- 2426-08-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(butoxymethyl)oxirane
- Reference substance name:
- n-butylglycidyl ether
- IUPAC Name:
- n-butylglycidyl ether
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): glycidol; C-4 (butyl-GE), butyl glycidyl ether
- Substance type: pure active
- Analytical purity:
97.7% (glycidol)
99.1% (butyl glycidyl ether)
- Impurities (identity and concentrations):
0.4% C4 alcohol (butyl glycidyl ether)
- Other:
Glycidol and the butyl glycidyl ether were obtained in high purity by the following procedure: Glycidol, and butyl glycidyl ether were purchased and purified by fractional vacuum distillation.
The substances were characterized by gas liquid chromatography on a Hewlett Packard instrument equipped with a 2-m stainless steel column packed with SP2100 (Supelco). Oxirane levels were determined as described by Walker (Walker, R.O. (Ed.) (1978) Oxirane Oxygen, Official and Tentative Methods of the American Oil Chemists Society, Tentative Method Cd 9-57, 508 South Sixth Street, Champaign, IL 61820.). Free epichlorohydrin was determined by gas liquid chromatography of the head space.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- tk+
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- The L5178Y mouse lymphoma cells were obtained from Dr. D. Clive, Burroughs Welcome Co.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenates prepared from Aroclor-1254-induced Sprague-Dawley rats; non-induced liver homogenate was prepared in the same manner from Sprague-Dawley rats injected with corn oil
- Test concentrations with justification for top dose:
- 5 or more concentrations were used for the mutation assay. The highest dose was set at twice the level that killed 50% of the organisms in the toxicity assay.
Glycidol: 8, 15, 23, 30, 45, 60, 75, 94, 125, 187, 250 µg/mL
Butyl glycidyl ester: 84, 100, 130, 164, 200, 256, 300, 320, 400, 500, 640, 800 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- N-dimethylnitrosamine
- ethylmethanesulphonate
- Remarks:
- Positive control without S9 fraction was ethyl methanesulfonate, 620 µg/ml; with induced S9 fraction, 2-acetylaminofluorene, 100 µg/ml; with uninduced S9 fraction, dimethylnitrosamine, 74 µg/ml.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 48h
- Selection time (if incubation with a selection agent): 10-12 days
SELECTION AGENT (mutation assays): 1 µg/ml trifluorothymidine
NUMBER OF REPLICATIONS: A single tube was prepared for each dose level, and the treated cells were cloned in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; other: trypan blue exclusion - Evaluation criteria:
- A compound was considered positive if dose-related increases in the mutation index over at least 3 concentrations with the highest response at least equal to 3.0 were obtained.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- both glycidol and butyl glycidyl ether
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The results of the mouse lymphoma assay are shown in Table 1. The assays were first performed over a wide range of concentrations, then rerun over the narrow ranges shown in the table to demonstrate dose response. The relative growth column is an index of the amount of toxicity to the cells. In most cases the range of concentrations was restricted to 5-fold or less due to toxicity. The mutation frequency was calculated by dividing the number of colonies appearing in the selective plates (TFT) by the number of surviving cells as determined by plating a sample of cells in the absence of the selective agent. The mutation index was calculated by dividing the mutation frequency of the test results by the mutation frequency of the solvent control. For this particular set of experiments, we considered a compound positive if dose-related increases in the mutation index over at least 3 concentrations with the highest response at least equal to 3.0 were obtained. The mouse lymphoma assays were performed without metabolic activation, with metabolic activation by non-induced rat liver microsome preparation, and with an Aroclor-1254-induced rat liver microsome preparation.
In general, the highest mutagenic responses were obtained in the assays without metabolic activation. Responses obtained were slightly reduced in the assays that used the non-induced S9 preparations, whereas much lower responses were obtained with the Aroclor-induced S9 preparations. Cell toxicity was reduced proportionally, i.e. the same dose of chemical produced a more toxic response in the absence of any S9 and a less toxic response in the presence of the S9.
Glycidol and the butyl glycidyl ether gave distinctly positive responses either with one of the S9 preparations or without activation. On a molar basis glycidol was considerably more potent than glycidyl ether.Table 1: Results of the L5178Y TK+/- mouse lymphoma mutagenicity assay for glycidol and Butyl glycidyl ester ± S9 mix
Compound (µg/ml) |
Relative growth (percent of control) |
Mutation frequency per 10exp6 survivors |
Mutation index (ratio of test/control) |
||||||
No S9a |
I S9b |
UI S9c |
No S9a |
I S9b |
UI S9c |
No S9a |
I S9b |
UI S9c |
|
Glycidol |
|||||||||
250 |
- |
9.5 |
- |
- |
497 |
- |
- |
13.1 |
- |
187 |
- |
34.9 |
- |
- |
302 |
- |
- |
7.9 |
- |
125 |
- |
69.5 |
- |
- |
148 |
- |
- |
3.9 |
- |
94 |
- |
99.4 |
- |
- |
113 |
- |
- |
3.0 |
- |
75 |
- |
- |
46.1 |
- |
- |
507 |
- |
- |
9.1 |
60 |
- |
- |
48.7 |
- |
- |
301 |
- |
- |
5.4 |
45 |
- |
- |
44.8 |
- |
- |
287 |
- |
- |
5.1 |
30 |
6.5 |
- |
42.5 |
727 |
- |
176 |
21.4 |
- |
3.1 |
23 |
25.1 |
- |
- |
581 |
- |
- |
17.1 |
- |
- |
15 |
67.4 |
- |
77.7 |
277 |
- |
78 |
6.7 |
- |
1.4 |
8 |
80.1 |
- |
- |
141 |
- |
- |
4.1 |
- |
- |
Solvent control |
100.0 |
100.0 |
100.0 |
34 |
38 |
56 |
1.0 |
1.0 |
1.0 |
Positive controle |
38.5 |
65.0 |
50.0 |
818 |
140 |
1280 |
24.5 |
3.7 |
22.9 |
Butyl glycidyl ester |
|||||||||
800 |
- |
5.3 |
- |
- |
751 |
- |
- |
26.7 |
- |
640 |
- |
34.1 |
- |
- |
236 |
- |
- |
8.4 |
- |
500 |
- |
53.6 |
7.7 |
- |
193 |
353 |
- |
6.9 |
17.6 |
400 |
- |
59.4 |
22.3 |
- |
164 |
235 |
- |
5.8 |
11.7 |
320 |
- |
- |
39.9 |
- |
- |
125 |
- |
- |
6.2 |
300 |
4.2 |
- |
- |
805 |
- |
64 |
17.9 |
- |
- |
256 |
- |
- |
61.7 |
- |
- |
59 |
- |
- |
3.2 |
200 |
16.7 |
- |
54.2 |
681 |
- |
63 |
15.1 |
- |
2.9 |
164 |
- |
- |
46.3 |
- |
- |
35 |
- |
- |
3.1 |
130 |
- |
- |
81.8 |
- |
- |
37 |
- |
- |
1.7 |
100 |
58.1 |
116.6 |
79.6 |
133 |
4 |
37 |
3.0 |
0.3 |
1.8 |
84 |
- |
- |
80.9 |
- |
- |
38 |
- |
- |
1.9 |
Solvent control |
100.0 |
100.0 |
100.0 |
45 |
28 |
20 |
1.0 |
1.0 |
1.0 |
Positive controld |
8.4 |
48.1 |
47.5 |
1410 |
90 |
84 |
31.3 |
3.2 |
4.1 |
a Without exogenous metabolic activation.
b With Aroclor-induced S9 fraction.
c With uninduced S9 fraction.
d Positive control without S9 fraction was ethyl methanesulfonate, 620 µg/ml; with induced S9 fraction, 2-acetylaminofluorene, 100 µg/ml; with uninduced S9 fraction, dimethylnitrosamine, 74 µg/ml.
e Positive control with S9 fraction for this compound only was benzo[a]pyrene, 3 µg/ml.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation glycidol
positive without metabolic activation glycidol
positive with metabolic activation butyl glycidyl ester
positive without metabolic activation butyl glycidyl ester
The mutagenic potential of the the read-across substances glycidol and butyl glycidyl ester for '1,2,3-propanetriol, glycidyl ethers' was performed in a study similar to OECD 476, assessed with Klimisch 2. Hence, the results are considered as sufficiently reliable to cover this endpoint.
In this assay, a compound was considered positive if dose-related increases in the mutation index over at least 3 concentrations with the highest response at least equal to 3.0 were obtained. These criteria are met for both glycidol and butyl glycidyl ester, without metabolic activation as well as with the induced and non-induced S9 fraction. Hence, both substances and hence '1,2,3-propanetriol, glycidyl ethers' has to be considered as mutagenic in the mouse lymphoma assay. - Executive summary:
In a mammalian gene mutation assay (Mouse lymphoma assay, similar to OECD 476). L5178Y cell cultures were exposed to the read-across substances glycidol and butyl glycidyl ester for '1,2,3-propanetriol, glycidyl ethers' at concentrations of 8, 15, 23, 30, 45, 60, 75, 94, 125, 187, 250 µg/ml (glycidol) or 84, 100, 130, 164, 200, 256, 300, 320, 400, 500, 640, 800 µg/ml with and without metabolic activation. The metabolic activation system was either liver homogenates prepared from Aroclor-1254-induced Sprague-Dawley rats or rats injected with corn oil (non-induced).
Glycidol and butyl glycidyl ester were both tested up to cytotoxic concentrations, i.e. the highest dose was set at twice the level that killed 50% of the organisms in the toxicity assay.
Positive controls (ethyl methanesulfonate, 620 µg/ml, –S9; 2-acetylaminofluorene, 100 µg/ml, + induced S9; dimethylnitrosamine, 74 µg/ml, + uninduced S9) induced the appropriate responses. For both glycidol and butyl glycidyl ester there was a concentration-related positive response as well as the stipulated at least three-fold increase of the mutation frequency over background without or with both available metabolic activation systems. So it can be concluded that '1,2,3-propanetriol, glycidyl ethers' has to be considered as mutagenic in the mouse lymphoma assay, too.
This study is classified as acceptable, reliable with restrictions and satisfies the requirements for OECD guideline 476 for in vitro mammalian cytogenicity data.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.