No IUPAC name is currently defined for Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”).

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol

EC Number:

700-991-6

Cas Number:

8007-24-7

Molecular formula:

Cardanol (saturated side chain): Formula: C21 H36 O Cardanol (monoene): Formula: C21 H34 O Cardanol (diene): Formula: C21 H32 O Cardanol (triene): Formula: C21 H30 O

IUPAC Name:

3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol

Details on test material:

- Name of test material (as cited in study report): Cardolite NC511 (distilled grade)
- Other: dark brown liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

arochlor induced rat liver S9 extract

Test concentrations with justification for top dose:

0, 50, 150, 500, 1500 or 5000 µg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

Migrated to IUCLID6: TA100 and TA1535

Controls 2

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: TA1537

Controls 3

Positive control substance:

other: 4-nitro-o-phenylenediamine TA1538

Controls 4

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

Migrated to IUCLID6: TA98

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

For a positive result, a dose related and statistically significant increase in mutation rate in one or more strains of bacteria in the presence or absence of S9 at sub-toxic dose levels should be induced.

Statistics:

Dunnet's method of linear regression.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Observed at and above 1500 µg/plate


RANGE-FINDING/SCREENING STUDIES: The test material was non-toxic in Salmonella strain TA100 up to 5000 µg/plate.


ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxicity was exhibited to any strain used.

Any other information on results incl. tables

No significant increase in the frequency of revertant colonies of bacteria were recorded for any of the strains used, at any dose level with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material was not genotoxic to Salmonella strains with and without metabolic activation.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA 1537 and TA1538 of S. typhimurium were exposed to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), at concentrations of 0, 50, 150, 500, 1500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation.

The positive controls induced the appropriate responses in the corresponding strains.   There was no evidence of induced mutant colonies over background for the test substance.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.