Endpoint study record: Chromosomal Aberration (OECD 

473) - Vertellus 2012 

Administrative Data 

Data source 

Reference 

Data access 

Data protection claimed 

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 Vitro Mammalian Chromosome Aberration Test) no 

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

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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 vitro Mammalian Chromosome Aberration Test no 

according 

to 

other guideline: EPA TSCA 40 CFR 799.9537 (TSCA in vitro 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 chromosomes (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 activation: 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 

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

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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 

ethylmethanesulphonate (and cyclophoshpamide) 

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 line. Therefore, the test item is considered to be nonclastogenic in this chromosome aberration test. 

To investigate the potential of Oxidized Castor Oil to induce structural chromosome aberrations in Chinese hamster V79 

cells, an in vitro chromosome aberration assay was carried out.

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

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The 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 each concentration. 100 metaphases per culture were scored for 

structural chromosomal aberrations (for exceptions, see tables).

The following concentrations were evaluated for the 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 activation 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 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 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 activation, 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.

Endpoint study record: Chromosomal Aberration (OECD 473) - Vertellus 2012 Page 4 of 4

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