Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 293-209-3 | CAS number: 91052-49-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 03 May 2010 - 12 Jun 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
- EC Number:
- 293-170-2
- EC Name:
- Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates
- Cas Number:
- 91052-13-0
- Molecular formula:
- C15H26O6, C19H34O6, C21H38O6, C25H46O6
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- other: CHL/IU
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 6h treatment with and without S9-mix: 0.02, 0.39, 0.078 and 0.156 mg/mL
24 and 48h treatment without S9-mix: 0.078, 0.156, 0.313, 0.625, 1.25, 2.5 and 5.0 mg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Based on the information from the sponsor, the test substance was insoluble in water and physiological saline. And the solubility test was performed with DMSO and acetone. The test substance was insoluble at 500.0 mg/mL in DMSO, and was dissolved at 500.0 mg/mL in acetone, and neither generation of gas nor exothermic reaction was observed. Therefore acetone was selected as solvent in this study.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9-mix
Migrated to IUCLID6: 0.1 µg/mL ( 6 h treatment), 0.05 µg/mL (24 and 48 h treatment)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9-mix
Migrated to IUCLID6: 7 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6, 24 and 48 h
- Expression time (cells in growth medium): 18 h after 6 h treatment
SPINDLE INHIBITOR (cytogenetic assays): 0.2 µg/mL colcemid
STAIN (for cytogenetic assays): 0.1% crystal violet solution
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
OTHER EXAMINATIONS:
- Determination of polyploidy: yes, cells carrying greater than 38 chromosomes including triploid were recorded as polyploidy - Evaluation criteria:
- The following criteria were set to evaluate the frequency of aberrant cells in each dose group:
A final judgment was concluded excluding gaps, nevertheless, separate records were kept for both including and excluding gaps.
Negative (-) less than 5%
Equivocal (+-) 5% or more, less than 10%
Positive (+) 10% or more
Results and discussion
Test results
- Species / strain:
- other: CHU/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at concentrations of 0.078 µg/mL and higher
RANGE-FINDING/SCREENING STUDIES: In the results of the cell growth inhibition test, the dose of 50% cell growth inhibition was 5.0 mg/mL and
more all of without S9 mix, with S9 mix, 24 h and 48 h exposure. In addition, the cell growth inhibition was observed, though the cell growth rate was more than 50% at the 0.156~1.25 mg/mL doses of the 24 h exposure and the 0,313~1.25 mg/mL doses of 48 h exposure.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes - Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Effects of the test substance on viability and chromosome aberrations.
Test item |
Concentration |
Cell viability |
Aberrant cells in % |
|
|
in µg/mL |
in % |
Numerical |
Structural including gaps |
Exposure period 6h without S9 mix |
||||
Untreated |
-- |
-- |
0.0 |
0.0 |
Solvent |
-- |
100 |
0.0 |
1.5 |
MMC |
0.010 |
105.5 |
0.0 |
39.5 |
Test substance |
0.020 |
101.0 |
0.5 |
0.0 |
0.039 |
98.0 |
1.0 |
1.5 |
|
0.078 |
88.0 |
0.0 |
0.0 |
|
0.156 |
82.5 |
0.5 |
1.0 |
|
Exposure period 6h with S9 mix |
||||
Untreated |
-- |
-- |
0.0 |
2.0 |
Solvent |
-- |
100 |
0.0 |
0.5 |
B(a)P |
7.000 |
96.5 |
0.0 |
28.5 |
Test substance |
0.020 |
96.0 |
0.0 |
2.0 |
0.039 |
92.0 |
0.0 |
0.0 |
|
0.078 |
86.0 |
1.0 |
0.5 |
|
0.156 |
84.5 |
0.5 |
1.0 |
|
Exposure period 24h without S9 mix |
||||
Untreated |
-- |
-- |
1.0 |
0.5 |
Solvent |
-- |
100 |
0.5 |
0.0 |
MMC |
0.050 |
102.0 |
0.0 |
41.5 |
Test substance |
0.078 |
90.5 |
0.0 |
0.5 |
0.156 |
82.5 |
0.0 |
1.0 |
|
0.313 |
76.0 |
1.0 |
1.0 |
|
0.625 |
66.0 |
0.0 |
0.5 |
|
1.250 |
66.0 |
0.5 |
2.0 |
|
2.500 |
84.5 |
0.5 |
0.0 |
|
5.000 |
92.0 |
0.0 |
1.0 |
|
Exposure period 48h without S9 mix |
||||
Untreated |
-- |
-- |
0.0 |
0.0 |
Solvent |
-- |
100 |
0.5 |
0.0 |
MMC |
0.050 |
94.0 |
0.0 |
58.5 |
Test substance |
0.078 |
99.0 |
0.0 |
1.0 |
0.156 |
86.5 |
0.0 |
0.5 |
|
0.313 |
74.5 |
1.0 |
0.0 |
|
0.625 |
70.0 |
0.0 |
0.0 |
|
1.250 |
79.5 |
0.5 |
0.0 |
|
2.500 |
87.5 |
0.5 |
0.0 |
|
5.000 |
92.5 |
0.5 |
1.0 |
|
B(a)P: Benz(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
