di-, tri- and tetrachlorotetradecane

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:

other: Guideline study, to GLP

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Reference 2

Reference Type:

secondary source

Title:

Chlorinated paraffins

Author:

IPCS

Year:

1996

Bibliographic source:

Environmental Health Criteria 181

Reference 3

Reference Type:

secondary source

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

This test system does not have the ability to detect certain oxidising or cross-linking mutagens

GLP compliance:

no

Remarks:

Data audited by RBM S.p.A. quality assurance unit

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Alkanes, C14-17, chloro

EC Number:

287-477-0

EC Name:

Alkanes, C14-17, chloro

Cas Number:

85535-85-9

Molecular formula:

Substance is a range of chlorinated isomers of C14 to C17 paraffin

IUPAC Name:

Alkanes, C14-17, chloro

Details on test material:

- Name of test material (as cited in study report): Solvocaffaro C1642
- Substance type: technical product
- Physical state: pale yellow liquid
- Analytical purity: no data
- Composition of test material, percentage of components: a C14-17 n-paraffin, 42% chlorination
- Impurity: no details on presence or absence of a stabiliser
- Lot/batch No.: Gi 2/88

Method

Target gene:

histidine biosynthesis

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:

Obtained from the liver of male rats administered Aroclor 1254

Test concentrations with justification for top dose:

1, 10, 100, 1000 and 5000 µg/plate (but erroneously reported as up to 5000 mg/plate in the draft EU RAR, 2008).

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Hydrazine sulphate, 9-aminoacridine-HCl, doxorubicine HCl, 2-aminofluorene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in mediumDURATION- Preincubation period: none- Exposure duration: 72 hNUMBER OF REPLICATIONS: 3 plates/dose level; duplicate experiments carried out on separate occassions.

Evaluation criteria:

Test article considered positive if the mean number of revertant colonies is significantly greater than controls and a dose-response is verified over at least 3 doses

Statistics:

Student's t-test for comparison of numbers of revertants between test and control incubations and linear regression test for dose-response evaluation.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

no data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Data erroneously reported for Salmonella typhimurium strain TA199 in IPCS EHC 181 (1996), should read strain TA100

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):negative C14-17 chlorinated paraffin; 42% chlorinationThe C14-17 chlorinated paraffin (Solvocaffero C1642) was not mutagenic in the Ames assay with five Salmonella typhimurium strains, with or without the addition of a rat liver metabolic activation system.

Executive summary:

In an OECD 471 guideline study, a C14-17 chlorinated paraffin (Solvocaffero C1642; 42% chlorination) was tested in the Ames assay with and without rat liver metabolic activation (S9) at up to a maximum concentration of 5000 µg/plate. The bacterial strains used were Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538. (This test system does not have the ability to detect cross-linking or certain oxidising mutagens). Negative and positive control groups validated the study.

Solvocaffero C1642 did not induce any significant increase in the number of reversions compared to controls, both in the presence or absence of S9, when tested up to 5 mg/plate on two separate occasions. Therefore this C14-17 chlorinated paraffin is considered to be non-mutagenic under the conditions of the test.