Castor oil, dehydrated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although the study is well documented, meets generally accepted scientific principles, acceptable for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy

IUPAC Name:

Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy

Details on test material:

- Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8). Under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'

Method

Target gene:

Not applicable

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100

Details on mammalian cell type (if applicable):

Not reported

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

10 and 30% Aroclor 1254-induced S9 from male Syrian hamster liver and male Sprague Dawley rat liver

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333 and 10000 µg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Tested on TA100 and TA1535

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Tested on TA97

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

Tested on TA 98, without metabolic activation

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: Pre-incubation. The detailed protocol of Zeiger et al. (1988) was followed.

NUMBER OF REPLICATIONS: Three

Evaluation criteria:

Not reported

Statistics:

Not reported

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

None

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

Under the test conditions, castor oil can be considered to be non-mutagenic in a Salmonella typhimurium mutation assay (Ames test).

Executive summary:

A study was performed to investigate the potential mutagenicity of castor oil through the reverse mutation assay using Salmonella typhimurium strains TA 1535, TA 97, TA 98 and TA 100, along with Aroclor-induced 10 and 30% liver fraction for metabolic activation (S9-mix).

Salmonella strains were exposed to five different concentrations (0, 100, 333, 1,000, 3,333 and 10,000 µg/plate) of castor oil and vehicle control (DMSO), in both absence and the presence of S9-mix. Three parallel plates were used for each dose. Concurrent positive controls, 2-aminoanthracene (for all strains, with metabolic activation), 4-nitro-o-phenylenediamine (on TA 98, without metabolic activation), sodium azide (TA100 and TA1535) and 9-aminoacridine (TA97) were also included in the assays.

In both absence and presence of the S9-mix, castor oil did not cause a significant increase in the number of revertant colonies in comparison to the control. Both positive and vehicle control groups were also valid.

Hence, under the test conditions, castor oil can be considered to be non-mutagenic in a Salmonella mutation assay (Ames test).