# Endpoint study record: Chromosomal Aberration (OECD 473) - Vertellus 2012

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# Materials and methods Type of genotoxicity Type of study Test guideline UUID IUC5-9f33c19d-2b0f-4fcf-b7db-e39ae727593b Dossier UUID 0 Author mbogle / Vertellus Specialties Inc. Date 2012-05-31 10:48:47 EDT Remarks

Purpose flag key study; robust study summary; used for classification; used for MSDS Study result type experimental result Study period 24 August 2011 to 8 February 2012 Reliability 1 (reliable without restriction)

Reference type Author Year Title Bibliographic source Testing laboratory Report no. Owner company Company study no. Report date study report OppongNketiah, M 2012 In Vitro Mammalian Chromosomal Aberration Test in Chinese Hamster V79 Cells with Oxidized Castor Oil (aka Pale 16, Material # 104495) BSL Bioservice Scientific Laboratories GmbH, Planegg, Germany 114189 Vertellus Specialties Inc.

data submitter is data owner
yes, but willing to share

chromosome aberration

in vitro mammalian chromosome aberration test

Qualifier Guideline Deviations according to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test) no according EU Method B.10 (Mutagenicity - In Vi tro Mammalian Chromosome Aberration Test) no 

# Page 1 of 4 Endpoint study record: Chromosomal Ab erration (OECD 473) - Vertellus 2012

5/31/2012 file://G:\TSCA\Test Rule - Ox idized Castor Oil\Robust Stud y Summaries\Chr Aberr.html

## GLP compliance 

# Test materials Identity of test material same as for substance defined in section 1 (if not read-across) Test material identity

Details on test material



# Method Target gene Species/strain

Test concentrations

Controls

to according to EPA OPPTS 870.5375 - In vi tro Mammalian Chromosome Aberration Test no according to other guideline: EPA TSCA 40 CFR 799.9537 (TSCA in vi tro mammalian chromosome aberration test, July 2010) no

yes

yes

Identifier Identity CAS name Castor Oil, Oxidized CAS number 68187-84-8
- Name of test material (as cited in study report): Oxidized Castor Oil (aka Pale 16, Material # 104495) - Physical state: liquid / yellow-amber - Analytical purity: 100% - Lot/batch No.: 0000113649 - Expiration date of the lot/batch: 30 June 2012 - Storage condition of test material: at room temperature

Chinese hamster V79 cells
Species/strain Chinese hamster lung fibroblasts (V79) Details on mammalian

cell lines (if applicable) V79 cells in vitro were chosen because of their relatively small numbero f chromosome s (diploid number, 2n = 22), their high proliferation rate (doubling time of the laboratory V79 done in stock cultures: 12-14 hr) and the high plating efficiency of untreated cells (normally more than 50%). The V79 (ATCC, CCL-93) cells are stored over liquid nitrogen (vapor phase) in the cell bank of BSL Bioservice, as large stock cultures allowing the repeated use of the same cell cuture batch in experiments. Routine checking for mycoplasma infections was carried out before freezing. Metabolic activation with and without Metabolic activation system S9

Pre-experiment for toxicity: 7.8 15.6, 31.3, 125, 250 500, 1000, 2500, and 5000 ug/mL (4 hours exposure duration) Experiment I, without metabolic activation: 15.6, 31.3, 62.5 , 125, 200, 250, 350, and 500 ug/mL (20 hours exposure duration) Experiment I, with metabolic activation: 62.5, 125, 250, 500, 1000, 2500, and 5000 ug/mL (4 hours exposure duration) Experiment II, without metabolic activa tion: 37.5, 75, 150, 200, 225, 250, 300, 350, 400, 500 and 600 ug/mL Experiment II, with metabolic activation: 200, 400, 800, 1200, 2000, 3000, 4000, and 5000 ug/mL 

# Page 2 of 4 Endpoint study record: Chromosomal Ab erration (OECD 473) - Vertellus 2012

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# Results and discussions Test results



# Overall remarks, attachments Attached full study report 

# Applicant's summary and conclusion Interpretation of results
Conclusions

Executive summary Negative controls yes (cell culture mediium (solvent or vehicle) alone) Solvent / vehicle controls yes (DMSO, Dimethylsulfoxide)

True negative controls no

Positive controls yes Positive control substance ethylmethanesulp honate (and cyclop hoshpamide)

Species/strain Chinese hamster lung fibroblasts (V79) Metabolic activation with and without

Test system all strains/cell types tested Genotoxicity negative Cytotoxicity no Vehicle controls

valid yes
Negative controls

valid yes

Positive controls

valid yes

Attached full study report Oxidized Castor Oil - Chromosomal Aberration (BSL Bioservice 2012).pdf / 1.68 MB (application/pdf)

negative
In conclusion, it can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item Oxidized Castor Oil (aka Pale 16, Mateiral # 104495) did not induce structural chromosomal aberrations in the V79 Chinese hamster cell lin e. Therefore, the test item is considered to be nonclastogenic in this chromo some aberration test.
To investigate the potential of Oxidized Castor Oil to induce structural chromosome aberrations in Chinese hamster V79 cells, an in vitro chromosome ab erration assay was carried out. 

# Page 3 of 4 Endpoint study record: Chromosomal Ab erration (OECD 473) - Vertellus 2012

5/31/2012 file://G:\TSCA\Test Rule - Ox idized Castor Oil\Robust Stud y Summaries\Chr Aberr.htmlThe chromosomes were prepared 20 h after start of treatment with the test item. The treatment interval was 4 h with and without metabolic activation in experiment I. In experiment II, the treatment interval was 4 h with and 20 h without metabolic activation. Duplicate cultures were treated at ea ch concentration. 100 metaphases per culture were scored for structural chromosomal aberration s (for exceptions, see tables). The following concentrations were evaluated for t he microscopic analysis of chromosomal aberrations: Experiment I: without metabolic activation: 62.5, 200, 250, 350 and 500 ug/mL with metabolic activation: 62.5, 500, 2500 and 5000 ug/mL Experiment II: without metabolic activation: 225, 350 and 500 ug/mL with metabolic activation: 200, 1200, 4000 and 5000 ug/mL In experiment I, precipitation of the test item was noted without metabolic ac tivation at concentrations of 125 ug/mL and higher, with metabolic activation at concentrations of 250 ug/mL and higher. In experiment II, precipitation of the test item was noted without metabolic activation at all concentrations evaluated, with metabolic activation at concentrations of 400 ug/mL and higher. In experiment I, without metabolic activation, toxic effects of the test item were observed at concentrations of 350 ug/mL and higher. With metabolic activation, toxic effects of the test item were noted only at the highest concentration of 5000 ug/mL. In experiment II, without metabolic activati on, toxic effects of the test item were observed at concentrations of 350 ug/mL and higher. With metabolic acti vation, toxic effects of the test item were noted at the highest concentration of 5000 ug/mL. In both experiments, no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control. In the experiments I and II with and without metabolic activati on, no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls. EMS (400 and 600 ug/mL) and CPA (0.83 ug/mL) were used as positive controls and induced distince and biologically relevant increases in cells with structural chromosomal aberrations. 

# Page 4 of 4 Endpoint study record: Chromosomal Ab erration (OECD 473) - Vertellus 2012

5/31/2012 file://G:\TSCA\Test Rule - Ox idized Castor Oil\Robust Stud y Summaries\Chr Aberr.html