(Z)-pent-2-enenitrile

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:

1990-08-28 to 1991-01-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted GLP study but only 4 strains were tested.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

4 strains tested

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-pent-2-enenitrile

EC Number:

247-323-5

EC Name:

(Z)-pent-2-enenitrile

Cas Number:

25899-50-7

Molecular formula:

C5H7N

IUPAC Name:

(2Z)-pent-2-enenitrile

Details on test material:

- Name of test material (as cited in study report): 2-pentenenitrile, (Z)
- Physical state: colorless liquid
- Stability under test conditions: assumed to be stable, no evidence of instability was observed

Method

Target gene:

Histidine revertant

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix from male Crl:CD rat injected i.p. with Aroclor 1254

Test concentrations with justification for top dose:

0, 500, 1000, 2000, 3000, 4000 and 5000 µg/plate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO (Baker Lot B51634)
- Justification for choice of solvent/vehicle: based on information supplied with the test material

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (Sigma Lot 33F-0816); 2-nitrofluorene (Aldrich Lot JPO3222JJ); sodium azide (Sigma Lot 26F-0434); ICR-191 Acridine (Raylo Chemicals Lot 178)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation period: 48 hours at 37 °C

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

A test sample is classified as positive when the average number of revertants in any strain at any test sample concentration studied is at least two
times greater than the average number of revertants in the solvent control and there is a positive dose-response relationship in that same strain.

Statistics:

Doses with and without activation were ranked and results from a strain were analyzed individually by were multiple linear regression. Comparisons
were made between each dose/concentration and the solvent control (0 rank) using the mean square error estimate. All comparisons were at the 95 %level of confidence.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No information

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 7.6.1/1: Results of mutagenicity assay with Cis-2-pentenenitrile and tester strain TA 1535

Concentration [µg/plate]	No. of revertants per plate**	No. of revertants per plate**	Cytotoxicity
	- MA	+ MA
0*	14 ± 3	13 ± 5	No
500	12 ± 4	11 ± 2	No
1000	12 ± 4	11 ± 3	No
2000	13 ± 1	10 ± 5	No
3000	11 ± 1	10 ± 4	No
4000	13 ± 5	14 ± 4	No
5000	13 ± 2	16 ± 5	No
Positive control	239 ± 15	261 ± 9

*solvent control with DMSO

** mean of 3 plates

 

Table 7.6.1/2: Results of mutagenicity assay with Cis-2-pentenenitrile and tester strain TA 97

Concentration [µg/plate]	No. of revertants per plate**	No. of revertants per plate**	Cytotoxicity
	- MA	+ MA
0*	102 ± 5	114 ± 18	No
500	105 ± 4	125 ± 8	No
1000	101 ± 9	126 ± 33	No
2000	98 ± 19	134 ± 14	No
3000	101 ± 7	130 ± 16	No
4000	103 ± 7	122 ± 25	No
5000	98 ± 10	108 ± 23	No
Positive control	1265 ± 34	1482 ± 72

*solvent control with DMSO

** mean of 3 plates

 

Table 7.6.1/3: Results of mutagenicity assay with Cis-2-pentenenitrile and tester strain TA 98

Concentration [µg/plate]	No. of revertants per plate**	No. of revertants per plate**	Cytotoxicity
	- MA	+ MA
0*	13 ± 4	19 ± 2	No
500	12 ± 3	28 ± 4	No
1000	13 ± 6	28 ± 6	No
2000	12 ± 2	21 ± 1	No
3000	14 ± 2	27 ± 9	No
4000	14 ± 5	25 ± 2	No
5000	14 ± 4	21 ± 5	No
Positive control	1590 ± 80	2096 ± 72

*solvent control with DMSO

** mean of 3 plates

 

Table 7.6.1/4: Results of mutagenicity assay with Cis-2-pentenenitrile and tester strain TA 100

Concentration [µg/plate]	No. of revertants per plate**	No. of revertants per plate**	Cytotoxicity
	- MA	+ MA
0*	100 ± 2	131 ± 4	No
500	96 ± 15	117 ± 13	No
1000	101 ± 4	110 ± 15	No
2000	104 ± 9	122 ± 9	No
3000	100 ± 11	115 ± 10	No
4000	94 ± 9	108 ± 7	No
5000	98 ± 8	114 ± 14	No
Positive control	413 ± 9	1871 ± 75

*solvent control with DMSO

** mean of 3 plates

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

There was no evidence of induced mutant colonies over background in this study

Executive summary:

In a reverse gene mutation assay in bacteria performed according to the OECD test guideline No. 471 and in compliance with GLP, strains TA 1535, TA 97, TA 98 and TA 100 of S. typhimurium were exposed to Cis-2-pentenenitrile (99.97 % pure) in DMSO at concentrations of 0, 500, 1000, 2000, 3000, 4000 and 5000 µg/plate in the presence and absence of mammalian metabolic activation (S-9 mix from male Crl:CD rat injected i.p. with Aroclor 1254).Cis-2-pentenenitrile was tested up to limit concentration. The positive controls induced the appropriate responses in the corresponding strains.  There was no evidence of induced mutant colonies over background.

 

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