Endpoint study record: Ames Assay (OECD 471) -

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-bb8a2cd3-5bc3-4514-8296-142cf46b7715 

Dossier UUID 0 

Author mbogle / Vertellus Specialties Inc.

Date 2012-05-31 09:46:30 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 24 November 2011 

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 

Donath, 

C 

2012 Reverse 

Mutation 

Assay using 

Bacteria 

(Salmonella 

typhimurium 

and 

Escherichia 

coli) with 

Oxidized 

Castor Oil 

(aka Pale 16, 

Material # 

104495) 

 BSL 

Bioservice, 

Planegg, 

Germany 

114188 Vertellus 

Specialties 

Inc. 

 

data submitter is data owner 

yes, but willing to share 

gene mutation 

bacterial reverse mutation assay (e.g. Ames test) 

Qualifier Guideline Deviations 

according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) 

Endpoint study record: Ames Assay (OECD 471) - Vertellus 2012 Page 1 of 5

file://G:\TSCA\Test Rule - Oxidized Castor Oil\Robust Study Summaries\FINAL Ames A... 5/31/2012
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 

according to EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) 

according to EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998) 

according to other guideline: 40 CFR 799.9510 "TSCA bacterial reverse mutation test", 10 July 2010 

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 

- Lot/batch No.: 0000113649 

- Expiration date of the lot/batch: 1 June 2012 

- Storage condition of test material: at room temperature 

S. typhimurium histidine (his) revision system

E. coli tryptophan (trp) revision system 

Species/strain S. typhimurium TA 98 

Additional 

strain 

characteristics 

other: his D 3052; rfa-; uvrB-; R-factor: frame shift mutations 

Metabolic 

activation 

with and without 

Metabolic 

activation 

system 

S9 

Species/strain S. typhimurium TA 100 

Additional 

strain 

characteristics 

other: his G 46; rfa-; uvrB-; R-factor: base-pair substitutions 

Metabolic 

activation 

with and without 

Metabolic 

activation 

system 

S9 

Species/strain S. typhimurium TA 1535 

Additional 

strain 

other: his G 46; rfa-; uvrB-: base-pair substitutions 

Endpoint study record: Ames Assay (OECD 471) - Vertellus 2012 Page 2 of 5

file://G:\TSCA\Test Rule - Oxidized Castor Oil\Robust Study Summaries\FINAL Ames A... 5/31/2012
Test concentrations 

Vehicle 

Controls 

characteristics 

Metabolic 

activation 

with and without 

Metabolic 

activation 

system 

S9 

Species/strain S. typhimurium TA 1537 

Additional 

strain 

characteristics 

other: his C 3076; rfa-; uvrB-; frame shift mutations 

Metabolic 

activation 

with and without 

Metabolic 

activation 

system 

S9 

Species/strain E. coli WP2 uvr A 

Additional 

strain 

characteristics 

other: trp-; uvrA-; base-pair substitutions and others 

Metabolic 

activation 

with and without 

Metabolic 

activation 

system 

S9 

Pre-experiment: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate.

Main experiment: 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. 

- Vehicle(s)/solvent(s) used: DMSO 

Negative 

controls 

yes (A. dest.) 

Solvent / 

vehicle 

controls 

yes (DMSO) 

Positive 

controls 

yes 

Positive 

control 

substance 

sodium azide 

Remarks S. typhimurium: TA100, TA1535; without metabolic activation 

Negative 

controls 

yes (A. dest.) 

Solvent / 

vehicle 

controls 

yes (DMSO) 

Positive 

controls 

yes 

Positive 

control 

substance 

other: 4-NOPD; 4-nitro-o-phenylene-diamine 

Endpoint study record: Ames Assay (OECD 471) - Vertellus 2012 Page 3 of 5

file://G:\TSCA\Test Rule - Oxidized Castor Oil\Robust Study Summaries\FINAL Ames A... 5/31/2012
Results and discussions 

Test results 

Overall remarks, attachments 

Overall remarks 

Remarks S. typhimurium: TA98, TA1537; without metabolic activation 

Negative 

controls 

yes (A. dest.) 

Solvent / 

vehicle 

controls 

yes (DMSO) 

Positive 

controls 

yes 

Positive 

control 

substance 

methylmethanesulfonate 

Remarks E. coli: WP2 uvrA; without metabolic activation 

Negative 

controls 

yes (A. dest.) 

Solvent / 

vehicle 

controls 

yes (DMSO) 

Positive 

controls 

yes 

Positive 

control 

substance 

other: 2-AA; 2-Aminoanthracene 

Remarks all strains, with metabolic activation 

Species/strain S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 

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 

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions 

reported, Oxidized Castor Oil (aka Pale 16, Material #104495) did not cause gene mutations by base pair changes or 

frameshifts in the genome of the tester strains used.

Therefore, Oxidized Castor Oil (aka Pale 16, Material #104495) is considered to be non-mutagenic in this bacterial 

reverse mutation assay.

Endpoint study record: Ames Assay (OECD 471) - Vertellus 2012 Page 4 of 5

file://G:\TSCA\Test Rule - Oxidized Castor Oil\Robust Study Summaries\FINAL Ames A... 5/31/2012
Attached full study report 

Applicant's summary and conclusion 

Interpretation of results 

Conclusions 

Attached full study report 

Oxidized Castor Oil - Ames Mutagenicity Assay (BSL Bioservice 2012).pdf / 1.51 MB (application/pdf) 

negative (both with and without metabolic activation) 

Oxidized Castor Oil did not cause gene mutations by base pair changes or frameshifts in the genome of the tester 

strains used. Therefore, Oxidized Castor Oil is considered to be non-mutagenic in this bacterial reverse mutation assay. 

Endpoint study record: Ames Assay (OECD 471) - Vertellus 2012 Page 5 of 5

file://G:\TSCA\Test Rule - Oxidized Castor Oil\Robust Study Summaries\FINAL Ames A... 5/31/2012