# 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 fo r 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 (B acterial Reverse Mutation Assay) 

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

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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

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 histidi ne (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 

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

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### 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 μ g/plate. Main experiment: 31.6, 100, 316, 1000, 2500 and 5000 μ g/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 

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

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# 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 descri bed mutagenicity test and under the experimental conditions reported, Oxidized Castor Oil (aka Pale 16, Material #104495) did not cause gene mutati ons 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. 

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### 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 fram eshifts in the genome of the tester strains used. Therefore, Oxidized Castor Oil is considered to be non-mutagenic in this bacterial reverse mutation assay. 

# Page 5 of 5 Endpoint study record: Ames A ssay (OECD 471) - Vertellus 2012

5/31/2012 file://G:\TSCA\Test Rule - Ox idized Castor Oil\Robust Stud y Summaries\FINAL Ames A ...