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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide
EC Number:
940-223-9
Molecular formula:
C10H18NO3Na C12H22NO3Na C14H26NO3Na
IUPAC Name:
Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
S9 homogenate
Test concentrations with justification for top dose:
0.025, 0.05, 0.1 mg/ml
Precipitation at 0.15 mg/ml
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
cyclophosphamide
mitomycin C

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
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

Any other information on results incl. tables

APPENDIX 1.INDIVIDUAL DATA OF PERCENTAGE MITOTIC INDEX FOR INITIAL CYTOTOXICITY TEST

Set No.

Treatment

Dose (µL/mL)

Replicate

Metaphases

Blast cells

Mitotic index

Percentage Mitotic index

1 (+S9) (3-5hours)

Negative control

-

1

37

997

0.0358

3.58

2

34

1006

0.0327

3.27

Vehicle control

-

1

34

1003

0.0328

3.28

2

35

1000

0.0338

3.38

Hostapon SLG

 

0.1

1

31

1004

0.0299

3.00

2

33

1023

0.0313

3.13

0.05

1

29

1011

0.0279

2.79

2

34

1001

0.0329

3.29

  0.025

1

34

1020

0.0323

3.23

2

33

1007

0.0317

3.17

2 (-S9) (3-5 hours)

Negative control

-

1

37

1007

0.0354

3.54

2

36

991

0.0351

3.51

VC

-

1

36

1007

0.0345

3.45

2

37

1006

0.0355

3.55

Hostapon SLG

 

0.1

1

33

1002

0.0319

3.19

2

32

1002

0.0309

3.09

0.05

1

33

1008

0.0317

3.17

2

34

1035

0.0318

3.18

  0.025

1

43

1209

0.0343

3.43

2

36

1039

0.0335

3.35

3 (-S9) (18-20 hours)

Negative control

-

1

40

1122

0.0344

3.44

2

40

1023

0.0376

3.76

VC

-

1

40

1048

0.0368

3.68

2

38

1028

0.0356

3.56

Hostapon SLG

 

0.1

1

37

1010

0.0353

3.53

2

37

1035

0.0345

3.45

0.05

1

38

1007

0.0364

3.64

2

35

1015

0.0333

3.33

  0.025

1

37

1003

0.0356

3.56

2

36

1003

0.0346

3.46

APPENDIX 2.INDIVIDUAL DATA OFCHROMOSOMAL ABERRATIONAND MITOTIC INDEX

Set No.

Treatment

Dose (µL/mL)

Replicate

Mitotic Index

Aberrations

Total No. of Aberrations

Total No. of Aberrations without Gaps

Total % of Aberrated cells

GAP

Break

Exchange

Fragments

Ring

Deletion

Total No. of MP

Total No. of Blast cells

Mitotic Index

Percentage of MI

Chromatid

Chromosome

Chromatid

Chromosome

Chromatid

Chromosome

1 (+S9) (3-5 hours)

Negative control

-

R1

37

968

0.0368

3.68

-

-

-

-

-

-

-

-

-

-

-

-

R2

35

971

0.0348

3.48

-

-

-

-

-

-

-

-

-

-

-

-

Vehicle control

-

R1

36

973

0.0357

3.57

-

-

-

-

-

-

-

-

-

-

-

-

R2

36

966

0.0359

3.59

-

-

-

-

-

-

-

-

-

-

-

-

Positive control (Cyclophosphamide )

10 µg/mL

R1

32

997

0.0311

3.11

-

-

1

-

1

0

2

1

5

10

10

9

R2

33

972

0.0328

3.28

-

-

1

3

0

0

1

1

3

9

9

8

Hostapon SLG

 

0.025

R1

34

979

0.0336

3.36

-

-

-

-

-

-

-

-

-

-

-

-

R2

34

988

0.0330

3.33

-

-

-

-

-

-

-

-

-

-

-

-

0.05

R1

32

971

0.0319

3.19

-

-

-

-

-

-

-

-

-

-

-

-

R2

33

1010

0.0316

3.16

-

-

-

-

-

-

-

-

-

-

-

-

0.1

R1

31

983

0.0306

3.06

-

-

-

-

-

-

-

-

-

-

-

-

R2

31

993

0.0303

3.03

-

-

-

-

-

-

-

-

-

-

-

-

APPENDIX 2(Contd..,). INDIVIDUAL DATA OFCHROMOSOMAL ABERRATIONAND MITOTIC INDEX

Set No.

Treatment

Dose (µL/mL)

Replicate

Mitotic Index

Aberrations

Total No. of Aberrations

Total No. of Aberrations without Gaps

Total % of Aberrated cells

GAP

Break

Exchange

Fragments

Ring

Deletion

Others*

Total No. of MP

Total No. of Blast cells

Mitotic Index

Percentage of MI

Chromatid

Chromosome

Chromatid

Chromosome

Chromatid

Chromosome

2 (-S9) (3-5 hours)

Negative control

-

R1

37

1012

0.0353

3.53

-

-

-

-

-

-

-

-

-

 

-

-

-

R2

35

965

0.0350

3.50

-

-

-

-

-

-

-

-

-

 

-

-

-

Vehicle control

-

R1

34

981

0.0335

3.35

-

-

-

-

-

-

-

-

-

 

-

-

-

R2

33

968

0.0330

3.30

-

-

-

-

-

-

-

-

-

 

-

-

-

Positive Control

(Mitomycin C)

0.05 µg/mL

R1

32

982

0.0316

3.16

2

-

1

-

-

-

3

1

3

2

12

10

8

R2

33

988

0.0323

3.23

2

3

1

2

-

-

-

1

1

3**

12

10

6

Hostapon SLG

 

0.025

R1

33

993

0.0322

3.22

-

-

-

-

-

-

-

-

-

 

-

-

-

R2

34

1006

0.0327

3.27

-

-

-

-

-

-

-

-

-

 

-

-

-

0.05

R1

31

971

0.0309

3.09

-

-

-

-

-

-

-

-

-

 

-

-

-

R2

32

1002

0.0319

3.19

-

-

-

-

-

-

-

-

-

 

-

-

-

0.1

R1

32

1023

0.0303

3.03

-

-

-

-

-

-

-

-

-

 

-

-

-

R2

32

1019

0.0304

3.04

-

-

-

-

-

-

-

-

-

 

-

-

-

APPENDIX 2(Contd..,). INDIVIDUAL DATA OFCHROMOSOMAL ABERRATIONAND MITOTIC INDEX

Set No.

Treatment

Dose (µL/mL)

Replicate

Mitotic Index

 

Aberrations

Total No. of aberrations

Total No. of aberrations without gaps

Total % of aberrated cells

GAP

Break

Exchange

Fragment

Ring

Deletion

Endoreduplication

Total No. of MP

Total No. of Blast cells

Mitotic Index

Percentage of MI

Chromatid

Chromosome

Chromatid

Chromosome

Chromatid

Chromosome

3 (-S9) (18-20 hours)

Negative control

-

R1

36

990

0.0351

3.51

-

-

-

-

-

-

-

-

-

-

-

-

-

R2

37

1020

0.0350

3.50

-

-

-

-

-

-

-

-

-

-

-

-

-

Vehicle control

-

R1

34

975

0.0337

3.37

-

-

-

-

-

-

-

-

-

-

-

-

-

R2

35

977

0.0346

3.46

-

-

-

-

-

-

-

-

-

-

-

-

-

Positive Control

(Mitomycin C)

0.05 µg/mL

R1

33

974

0.0334

3.34

-

4

2

3

-

-

1

1

4

-

15

11

9

R2

34

984

0.0324

3.24

4

-

-

2

-

-

3

1

1

1

12

8

5

Hostapon SLG

 

0.025

R1

34

982

0.0335

3.35

-

-

-

-

-

-

-

-

-

-

-

-

-

R2

34

973

0.0338

3.38

-

-

-

-

-

-

-

-

-

-

-

-

-

0.05

R1

32

979

0.0317

3.17

-

-

-

-

-

-

-

-

-

-

-

-

-

R2

33

982

0.0325

3.25

-

-

-

-

-

-

-

-

-

-

-

-

-

0.1

R1

31

988

0.0304

3.04

-

-

-

-

-

-

-

-

-

-

-

-

-

R2

32

984

0.0315

3.15

-

-

-

-

-

-

-

-

-

-

-

-

-

Applicant's summary and conclusion

Conclusions:
Not clastogenic
Executive summary:

Hostapon SLG was investigated according to the Guideline OECD 473 (version 1997). CHO cells were treated with the test substance with and without metabolic activation at concentrations of 0.025, 0.05 and 0.1 mg/ml. The concentration of 0.15 mg/l was associated with enhanced precipitation. Negative results were obtained in two indenpendent experiments. Hostapon SLG is not clastogenic in in-vitro assay.