Reaction product of adipic acid and sebacic acid and isotridecan-1-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (only single plating, dissimilar positive control substances), read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

; only single plating, dissimilar positive control substances

Principles of method if other than guideline:

Pre-guideline study; but the method used is similar to OECD test guideline 471

GLP compliance:

no

Remarks:

pre-GLP study

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diisotridecyl adipate

EC Number:

247-660-8

EC Name:

Diisotridecyl adipate

Cas Number:

26401-35-4

IUPAC Name:

bis(11-methyldodecyl) adipate

Details on test material:

- Name of test material (as cited in study report): MCTR-25-78
- Physical state: slightly viscous yellowish liquid
- no further information on test substance

Method

Target gene:

his¯ (S. thyphimurium)

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100

Species / strain 2

Species / strain / cell type:

Saccharomyces cerevisiae

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from livers of Aroclor 1254 induced male Sprague-Dawley rats

Test concentrations with justification for top dose:

0.01, 0.1, 1.0, 5.0, and 10.0 µL/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

50 µL solvent/plate

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9-mix : ethylmethansulfonate (TA1535, TA100, D4 ), QM (TA1537), nitrofluoren (TA98, TA1538); with S9-mix: anthracene (TA1535, TA1537, TA1538, TA98, TA100, D4)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: S. thyphimurium 48 h at 37°C ; S. cerevisiae 3 - 5 days at 30°C (nonactivation) or at 37°C (activation)
- Expression time (cells in growth medium): 48 h or 3-5 days

NUMBER OF REPLICATIONS: single plating

DETERMINATION OF CYTOTOXICITY
- Method: no data

Evaluation criteria:

Strains TA1535, TA1537, and TA 1538
If the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA98, TA100, and D4
If the solvent control value is within the normal range a chemical that produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control value for TA100 and 2-3 times the solvent control value for strains TA98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.
Reproducibility
If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the initial positive test data lose significance.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

; at the highest doses some cytotoxicity was observed

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

Saccharomyces cerevisiae

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

; at the highest doses some cytotoxicity was observed

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

For detailed results, see Attached background material.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Diisotridecyl adipate was not mutagenic as it did not increase the number of revertants in five strains of Salmonella typhimurium or in Saccharomyces cerevisiae strain D4 with or without metabolic activation in an Ames test performed similar to OECD TG 471.

Executive summary:

In a gene mutation assay according to Ames (1975), strains of Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537, TA 1538) and Saccharomyces cerevisiae (strain D4) were exposed to diisotridecyl adipate at concentrations of 0.01, 0.1, 1.0, 5.0, and 10 µL/plate in the presence and absence of mammalian metabolic activation. Exposure was in agar (plate incorporation method) and only single plates were used per test concentration.

 

Diisotridecyl adipate was tested up to the limit concentration of 10 µL/plate, which exhibited slight toxicity. The positive controls induced the appropriate responses in the corresponding strains. Diisotridecyl adipate did not increase the number of revertants in the test strains used. There was no evidence of induced mutant colonies over background.

 

This study is classified as acceptable with restrictions due to some deviations from OECD test guideline 471 (only single plating, dissimilar positive control substances).