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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Referenceopen allclose all

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: GLP laboratory study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Also, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S-9 rat liver homogenate
Test concentrations with justification for top dose:
0, 4, 20, 100, 500, 2500, and either 10000 (1st expt) or 5000 (2nd experiment) micrograms/plate
Vehicle / solvent:
On the day of the experiment the test substance was dissolved in DMSO at appropriate concentrations.
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide (TA100, TA1535), 9-aminoacridine (TA1537), 2-nitrofluorene (Ta98, TA1538)
Evaluation criteria:
A test article is classified mutagenic if either of the following conditions are achieved:
a) test article produces at least a 2-fold increase in mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn,
b) a test article induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.
Statistics:
Standard statistics are employed.
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:
cytotoxicity
Remarks:
Toxic to most strains at 500 micrograms/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Same results for TA 1538

The test material was toxic to most of the bacterial strains at a dose of 500 micrograms/plate. Thinning of the bacterial lawn and a reduction in the number of colonies were observed at this dose. For mutagenicity testing, 5000 mictrograms/plate was chosen as the highest dose in the second experiment.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

The test material is not mutagenic in the bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
Executive summary:

Phenylsulfonat CA was tested for mutagenicity in the Ames test using strains TA 100, TA 1535, TA 1537, TA 1538 and TA 98 of Salmonella typhimurium. Studies were conducted in the presence and absence of S-9 metabolic activity derived from rat liver homogenate. Six doses ranging from 4 to 5000 micrograms/plate were tested in the mutagenicity test. Negative and positive controls showed the expected results and the test is valid. The test material was toxic to most of the bacterial strains at 500 micrograms/plate and 5000 micrograms/plate was chosen as the top dose level for the mutagenicity study. Phenylsulfonat CA did not result in relevant increases in the number of revertant colonies, either in the presence or absence of a metabolic activation system. Phenylsulfonat CA is not mutagenic in this study.

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
May 16, 1995-June 30, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian cell gene mutation assay
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
S9 from aroclor 1254 induced rat liver
Test concentrations with justification for top dose:
0, 0.6, 1, 1.8, 3, 6 ug/ml without S9
0, 6, 10, 18, 30, 60 ug/ml with S9
Vehicle / solvent:
None
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
yes
Remarks:
H0 medium
Positive controls:
yes
Positive control substance:
other: ethyl methane sulfonate; 3-(20-)methylcholanthrene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium


DURATION
- Preincubation period: 1 week
- Exposure duration: 4 hrs
- Expression time (cells in growth medium): 6 days at 37 degree C for cloning efficiency study, 9 days for mutation assay


STAIN (for cytogenetic assays): Giemsa


NUMBER OF REPLICATIONS: 2


Evaluation criteria:
A test substance was considered mutagenic if a statistically significant dose-related increase in mutant frequency was found in concentrations with greater than 20% survival rate. The mean mutant frequency must also be significantly above the maximum spontaneous mutant frequency.
Statistics:
Statistical significance was determined by the t-test.
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
preliminary test showed cytotoxicity at >= 50 ug/ml without S9, and >= 100 ug/ml with S9.
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: In both the studies with and without S9, the mutant frequencies in the treated groups were statistically significantly higher than in the concurrent negative controls. However, the mutant frequencies in the treated groups were not significantly increased when compared to historical negative controls. There was also no dose-response relationship. The increased mutant frequency in treated groups was therefore not considered to be biologically significant.


Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Results of Test 1 – Without S9 Mix            

Concentration (ug/ml)

Absolute cloning efficiency (%)

Mutant frequency ( x 106)

0

82

3 ± 2

0.6

86

7 ± 1

1

85

3 ± 2

1.8

78

5 ± 2

3

86

1 ± 1

6

83

0 ± 1

EMS

83

277 ± 17

Results of Test 1 – With S9 Mix     

Concentration (ug/ml)

Absolute cloning efficiency (%)

Mutant frequency ( x 106)

0

90

2 ± 1

6

88

1 ± 1

10

84

9 ± 4

18

78

5 ± 3

30

89

3 ± 2

60

89

7 ± 2

MCA

81

91 ± 9

Results of Test 2 – Without S9 Mix

Concentration (ug/ml)

Absolute cloning efficiency (%)

Mutant frequency ( x 106)

0

96

1 ± 1

0.6

92

2 ± 3

1

95

1 ± 1

1.8

93

5 ± 2

3

90

2 ± 1

6

91

6 ± 6

EMS

90

309 ± 20

Results of Test 2 – With S9 Mix     

Concentration (ug/ml)

Absolute cloning efficiency (%)

Mutant frequency ( x 106)

0

90

2 ± 1

6

92

7 ± 3

10

88

9 ± 2

18

94

2 ± 1

30

93

2 ± 2

60

90

5 ± 1

MCA

95

89 ± 6

Conclusions:
Interpretation of results (migrated information):
negative

The test substance is not mutagenic in either the presence or absence of metabolic activation.
Executive summary:

This study examined the potential of the test substance to cause mutations in mammalian cells. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/ml without S9, and 0, 6, 10, 18, 30, and 60 ug/ml with S9. The cells were then examined for cytogenicity and mutation frequency. Ethyl methane sulfonate and 3-(20-)methylcholanthrene were used as positive control substances. Preliminary tests show the test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/ml or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP laboratory study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
micronucleus assay
Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
Strain NMRI. Animals were approximately 22-26 g (male) and 20-25 g (female) and acclimated for 1 week to the test conditions (20 =/- 3 degrees C, 30-70% relative humidity, 12 hour light/dark cycle). Food was given daily and water was ad libitum. All animals were healthy at the time of test initiation.
Route of administration:
oral: gavage
Vehicle:
NaCl
Duration of treatment / exposure:
72 hours
Frequency of treatment:
single dose
Remarks:
Doses / Concentrations:
1122 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
40 males and 40 females per dose
Control animals:
yes
Positive control(s):
Endoxan (cyclophosphamid)
Tissues and cell types examined:
Cells were taken from the thigh.
Details of tissue and slide preparation:
Cells were mixed with cattle serum and suspended, then centrifuged. The sediment was then resuspended. The suspension was seperated in a cellulose chromatography column. This was centrifuged, and mixed with fetal calf serum and EDTA. This was air-dried for 24 hrs and stained with Giemsa.
Evaluation criteria:
number of polychromatid erythrocytes (PCE)
ratio of PCE to normochromatid erythrocytes (NCE)
number of cells with micronucleus
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Branched CaDDBS (Phenylsulfonat CA) was tested for mutagenicity in the Ames test using strains TA 100, TA 1535, TA 1537, TA 1538 and TA 98 of Salmonella typhimurium. Studies were conducted in the presence and absence of S-9 metabolic activity derived from rat liver homogenate. Six doses ranging from 4 to 5000 micrograms/plate were tested in the mutagenicity test. Negative and positive controls showed the expected results and the test is valid. The test substance was toxic to most of the bacterial strains at 500 micrograms/plate and 5000 micrograms/plate was chosen as the top dose level for the mutagenicity study. Phenylsulfonat CA did not result in relevant increases in the number of revertant colonies, either in the presence or absence of a metabolic activation system. Phenylsulfonat CA is not mutagenic in this study.

Supporting studies conducted on LAS are also provided. The first study examined the potential of LAS to cause mutations in mammalian cells. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/ml without S9, and 0, 6, 10, 18, 30, and 60 ug/ml with S9. The cells were then examined for cytogenicity and mutation frequency. Preliminary tests show the test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/ml or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.

In an in vivo study, male and female NMRI mice were exposed to 1122 mg/kg LAS by gavage and assessed after 72 hours for chromosome aberrations. No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.

Short description of key information:

Branched CaDDBS (Phenylsulfonat CA) was tested for mutagenicity in the Ames test and did not result in relevant increases in the number of revertant colonies, either in the presence or absence of a metabolic activation system. Therefore, Phenylsulfonat CA is not mutagenic in this study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results in an Ames test with Branched CaDDBS and with one in vitro and one in vivo genotoxiicty studies conducted on LAS, Branched CaDDBS is not considered to be mutagenic.