Pentene

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

Study period:

06 June 1983 to October 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not applicable

Principles of method if other than guideline:

Bridges, B. A. (1972) Simple bacterial systems for detecting mutagenic agents. Lab. Practice, 21 413-416.

Ames, B.N., McCann, J. and Yamasaki, E. (1975) Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian-Microsome Mutagenicity Test. Mutation Res., 31, 347-364.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Pentene

EC Number:

246-916-6

EC Name:

Pentene

Cas Number:

25377-72-4

Molecular formula:

C5H10

IUPAC Name:

pent-1-ene

Details on test material:

- Name of test material (as cited in study report): Pentene-1.(n-amylene)

- Physical state: Clear, colourless volatile liquid.

- Analytical purity: 94.4%

- Lot/batch No.: ST83/065

- Expiration date of the lot/batch:

- Stability under test conditions: The test substance was judged to have been stable for the duration of this study. (Formulations) The stabilities of formulations of the test substance in Tween 80/ethanol was stable for at least one working day (7.5 h).

- Storage condition of test material: In the dark at ambient temperature.

Method

Target gene:

Histidine operon (his) for Salmonella.
Tryptophan operon (trp) for E.Coli.

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 fraction

Test concentrations with justification for top dose:

Without S9 mix: 62.5, 125, 250, 500 and 1000 ug/ml
With S9 mix: 62.5, 125, 250, 500, 1000, 2000 and 4000 ug/ml

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

(concurrent vehicle control)

Negative solvent / vehicle controls:

yes

Remarks:

Tween 80/ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

for S. typhimurium with or without S9

Migrated to IUCLID6: 1.7 µg/ml

Controls 2

Untreated negative controls:

yes

Remarks:

(concurrent vehicle control)

Negative solvent / vehicle controls:

yes

Remarks:

Tween 80/ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

for S. typhimurium with or without S9

Migrated to IUCLID6: 10 µg/ml

Controls 3

Untreated negative controls:

yes

Remarks:

(concurrent vehicle control)

Negative solvent / vehicle controls:

yes

Remarks:

Tween 80/ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: neutral red, 10 µg/ml

Remarks:

for S. typhimurium with or without S9

Controls 4

Untreated negative controls:

yes

Remarks:

(concurrent vehicle control)

Negative solvent / vehicle controls:

yes

Remarks:

Tween 80/ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: potassium dichromate, 10 µg/ml

Remarks:

for E. coli with or without S9

Results and discussion

Test results

Test results 1

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100, E. coli WP2 uvr A pKM 101

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

> 1000 µg/ml

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100, E. coli WP2 uvr A pKM 101

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

> 4000 µg/ml

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The results of this study indicate that when examined over a wide range of concentrations Pentene-1 did not induce reverse mutation in bacteria (both with and without metabolic activation).

Executive summary:

The mutagenic activity of Pentene-1 was investigated in agar layer cultures of Escherichia coli and Salmonella typhimurium bacterial tester strains. Assay was performed both in the presence and absence of S9 microsomal fraction obtained from a liver homogenate from rats pretreated with Aroclor 1254.

The results indicate that Pentene-1 did not induce mutation in bacteria) under the conditions of the assays described.

The test was conducted following to the similar methodologies as OECD testguideline 471. There are no information available regarding the testing facility therefore a reliability of 2 is assigned.