Pent-1-ene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Well documented study but not performed under GLP. Testguideline similar to OECD test guideline, but the organism E.Coli was not tested. Substance purity not reported.

Data source

Reference

Reference Type:

other: Study result available in the National Toxicology Program database

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: NTP Standard Protocol

Deviations:

yes

Remarks:

The test was not conducted with E. Coli

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

The test was not conducted with E. Coli

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Pent-1-ene

EC Number:

203-694-5

EC Name:

Pent-1-ene

Cas Number:

109-67-1

Molecular formula:

C5H10

IUPAC Name:

pent-1-ene

Test material form:

not specified

Method

Target gene:

histidine gene

Species / strain

Species / strain / cell type:

bacteria, other: S. Typhimurium TA97, TA98, TA100, TA1535

Metabolic activation:

with and without

Metabolic activation system:

metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver S9 (10 and 30%)

Test concentrations with justification for top dose:

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

Vehicle / solvent:

Dimethyl Sulfoxide (DMSO)

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

Remarks:

without S9

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (or occasionnally, sterigmatocystin)

Remarks:

with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION:
preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 2 days

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

only slight cytotoxicity was measured for 10000 ug/plate without HLI

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Any other information on results incl. tables

See attachment in section "Attached background material".

Applicant's summary and conclusion

Conclusions:

Under the test condition,1-Pentene is not mutagenic with and without metabolic activation in S. typhimurium strains (TA1535, TA97, TA98 and TA100) according to the criteria of the Annex I of the of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a reverse gene mutation assay performed according to the NTP Standard Protocol (Ames Test), Salmonella typhimurium strains TA 1535, TA 97 and TA 98 and TA 100 were exposed to 1-pentene diluted in DMSO both in the presence and absence of metabolic activation system (S9 fraction) from 100 to 10000 µg/plate using the preincubation method. Vehicle (dimethyl sulphoxide) and positive control groups were also included in mutagenicity tests.

No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.

All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.

No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.

Under the test condition, test material is not mutagenic with and without metabolic activation in S. typhimurium (strains TA1535, TA97, TA98 and TA100) according to the criteria of the Annex I of the of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.