Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
with and without activation
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TA 1538 also tested negative. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 ug/plate. No precipitation of the product was observed at any concentration tested.
Conclusions:
LAS is not mutagenic in the Ames test.
Executive summary:

A bacterial mutagenicity study (Ames test) was conducted on LAS and was found to be negative for mutagenicity.

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
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.


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. 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:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 15 microgram/ml with S9, >=58 microgram/ml without S9
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
In the absence of S9, only one culture (Test 2, 24 hr harvest, 20 ug/ml) showed a suspicious result. This single result was considered sporadic, as other cultures at this concentration, or at higher concentrations did not show a positive response. In Test 1, in the absence of S9, cytoxicity was seen at 78 micrograms/ml and above. In Test 2, in the absence of S9, cytoxicity was seen at concentrations of 58 micrograms/ml and above.

In Test 1, in the presence of S9, no positive results were seen at concentrations of up to 20 micrograms/ml. Metaphases could not be analyzed due to severe cytotoxicity at the 39 and 78 microgram/ml concentrations. In Test 2, in the presence of S9, one of the cultures at the 5 microgram/ml concentration gave a suspicious result, and both cultures at the 10 microgram/ml concentrations gave positive responses. Mild cytotoxity was also seen at the 10 microgram/ml concentration. At concentrations at and above 20 micrograms/ml, metaphases could not be analyzed due to severe cytotoxicity. No positive results were seen in the Test 2, 48 hr harvest cultures grown in the presence of S9, though moderate cytotoxicity was seen in one of the 20 microgram/ml cultures, and severe cytotoxicity was seen in all cultures above this concentration.

A third test was done in the presence of S9, which showed positive results at the 15 micrograms/ml concentration. However, this concentration was also moderately cytotoxic with only 26% of cells survival. However, due to the low survival of cells, these results are not definitive for determining clastogenicity. Higher concentrations were completely cytotoxic. An additional assessment was then performed at 10 micrograms/ml in the presence of S9, with negative results.

Abbreviations used in tables:

T - Toxicity evident from morphological changes

TT- Toxicity evident from reduced cell count (<60% of vehicle)

TTT- Too toxic for metaphase assessment

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham's F10 medium

0.01

1

0

Nil

Ham's F10 medium

0.02

1

1

Nil

0.32

-

-

-

Nil

0.32

-

-

-

Nil

0.63

-

-

-

Nil

0.63

-

-

-

Nil

1.25

-

-

-

Nil

1.25

-

-

-

Nil

2.5

0.01

1

0

Nil

2.5

0.00

0

0

Nil

5

0.00

0

0

Nil

5

0.05

5

0

Nil

10

0.01

1

0

Nil

10

0.01

1

0

Nil

20

0.00

0

0

Nil

20

0.00

0

0

Nil

39

-

-

-

TTT

39

-

-

-

TTT

78

-

-

-

TTT

78

-

-

-

TTT

Cyclophosphamide (20 micrograms/ml)

0.14

8

4

-

Cyclophosphamide

(30 micrograms/ml)

0.06

4

4

-

Cyclophosphamide

(40 micrograms/ml)

0.33

20

19

-

Test 1 - Without S9 Mix, 24 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham's F10 medium

0.00

0

0

Nil

Ham's F10 medium

0.00

0

0

Nil

1.25

-

-

-

Nil

1.25

-

-

-

Nil

2.5

-

-

-

Nil

2.5

-

-

-

Nil

5

-

-

-

Nil

5

-

-

-

Nil

10

-

-

-

Nil

10

-

-

-

Nil

20

-

-

-

Nil

20

-

-

-

Nil

39

0.01

1

0

Nil

39

0.00

0

0

Nil

58

0.01

1

0

Nil

58

0.00

0

0

Nil

78

0.00

0

0

T

78

0.00

0

0

T

156

-

-

-

TTT

156

-

-

-

TTT

Methyl methane-sulphonate

(10 micrograms/ml)

0.03

3

1

-

Cyclophosphamide

(20 micrograms/ml)

0.16

14

10

-

Test 2 - With S9 Mix, 24 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham's F-10 medium

0.01

1

0

Nil

Ham's F-10 medium

0.02

2

1

Nil

2.5

0.07

2

1

Nil

2.5

0.04

3

1

Nil

5

0.04

3

2

Nil

5

0.06

6

4

Nil

10

0.12

8

6

T

10

0.19

13

5

T

20

-

-

-

TTT

20

-

-

-

TTT

26

-

-

-

TTT

26

-

-

-

TTT

33

-

-

-

TTT

33

-

-

-

TTT

39

-

-

-

TTT

39

-

-

-

TTT

Cyclophosphamide

(40 micrograms/ml)

0.38

20

17

-

Cyclophosphamide

(50 micrograms/ml)

0.31

18

11

-

Test 2 - With S9 Mix, 48 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham's F-10 medium

0.00

0

0

Nil

Ham's F-10 medium

0.00

0

0

Nil

2.5

0.01

1

0

Nil

2.5

0.01

1

1

Nil

5

0.00

0

0

Nil

5

0.02

2

2

Nil

10

0.03

2

1

Nil

10

0.02

2

1

TT

20

-

-

-

TTT

20

-

-

-

TTT

26

-

-

-

TTT

26

-

-

-

TTT

33

-

-

-

TTT

33

-

-

-

TTT

39

-

-

-

TTT

39

-

-

-

TTT

Cyclophosphamide

(40 micrograms/ml)

0.03

3

2

-

Cyclophosphamide

(50 micrograms/ml)

0.10

8

7

-

Test 2 ¿ Without S9 Mix, 24 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham¿s F-10 medium

0.02

2

2

Nil

Ham¿s F-10 medium

0.03

3

0

Nil

20

0.02

2

0

Nil

20

0.05

5

3

Nil

39

0.02

2

1

Nil

39

0.04

4

0

Nil

58

0.01

1

1

Nil

58

0.06

6

1

Nil

78

-

-

-

TTT

78

-

-

-

TTT

104

-

-

-

TTT

104

-

-

-

TTT

130

-

-

-

TTT

130

-

-

-

TTT

156

-

-

-

TTT

156

-

-

-

TTT

Methyl methane-sulphonate

(10 micrograms/ml)

0.30

21

14

-

Methyl methane-sulphonate

(20 micrograms/ml)

0.71

33

28

-

Test 2 - Without S9 Mix, 48 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytotoxicity

Ham's F-10 medium

0.01

1

1

Nil

Ham's F-10 medium

0.00

0

0

Nil

20

0.00

0

0

Nil

20

0.00

0

0

Nil

39

0.01

1

1

Nil

39

0.00

0

0

Nil

58

0.00

0

0

T

58

0.01

1

0

T

78

-

-

-

TTT

78

-

-

-

TTT

104

-

-

-

TTT

104

-

-

-

TTT

130

-

-

-

TTT

130

-

-

-

TTT

156

-

-

-

TTT

156

-

-

-

TTT

Methyl methane-sulphonate

(20 micrograms/ml)

0.21

11

8

-

Methyl methane- sulphonate

(40 micrograms/ml)

3.20

60

60

-

Test 3 - With S9 Mix, 24 hr Harvest

Concentration (micrograms/ml)

Aberration Frequency (lesions/cell)

Aberrant Cell Frequency (% Including Gaps)

Aberrant Cell Frequency (% Excluding Gaps)

Cytoxicity

Ham's F-10 medium

0.04

4

0

Nil

Ham's F-10 medium

0.04

4

0

Nil

2.5

-

-

-

Nil

2.5

-

-

-

Nil

5

-

-

-

Nil

5

-

-

-

Nil

7.5

-

-

-

Nil

7.5

-

-

-

Nil

10

-

-

-

Nil

10

-

-

-

Nil

15

0.20

12

8

TT

15

0.18

12

6

TT

20

-

-

-

TTT

20

-

-

-

TTT

25

-

-

-

TTT

25

-

-

-

TTT

30

-

-

-

TTT

30

-

-

-

TTT

Cyclophosphamide

(30 micrograms/ml)

0.24

14

12

-

Cyclophosphamide

(40 micrograms/ml)

0.32

17

11

-

Test 3 - see tables below

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation at cytotoxic concentrations or above

The test substance is not clastogenic in the absence of metabolic activation. The test substance is also not clastogenic in the presence of metabolic activation at non-cytotoxic concentrations. At cytotoxic concentrations, the test substance is weakly clastogenic.
Executive summary:

This study examined the potential of the test substance Marlon A 350 to cause chromosomal aberrations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 ug/ml with S9, and 1.25 to 156 ug/ml without S9. Methyl methanesuflphonate and cyclophosphamide were used as positive controls. No biologically significant results were seen in treated cultures in the absence of metabolic activation. Positive responses were seen at cytotoxic concentrations in the presence of S9. Concentrations below the level of cytotoxicty with S9 did not show positive results. The test substance is not clastogenic in the absence of metabolic activation, or with metabolic activation below cytotoxic concentrations. These results indicate that LAS is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations

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

Genetic toxicity in vivo

Description of key information

In vivo genotoxicity data indicate that the read-across source substance LAB Sulfonic Acids are not clastogenic. Additional data is available on LAS which provides suitable read across for LAB Sulfonic Acids as both form the identical chemical species in aqueous solutions at neutral (physiological) pH, namely, the LAS ion (C10-13 linear alkyl benzene-SO3-) and would be expected to have similar toxicological properties. LAS (read across) was consistently found not to cause induction of gene mutations in the Ames bacterial reverse mutation assay as well as in the OECD 476 in vitro mammalian cell gene mutation test. LAS (read across) was found to be weakly positive at cytotoxic concentrations, but negative at concentrations below cytotoxic concentrations, when tested in an in vitro chromosome aberration assay in CHO cells. When tested in a series of in vivo genotoxicity studies, LAS (read across) was consistently found to not cause any clastogenic or mutagenic responses. The positive result in the in vitro chromosome aberration study using a rodent cell line (CHO cells) derived from cancer tissues that is lacking proper cell cycle control has to be seen in the context of the extensive in vivo data. In vivo studies do assess genotoxicity under more realistic conditions, including exposure, and therefore the negative results in the in vivo studies together with the negative results in the Ames test do strongly indicate that LAS (read-across) and the read-across source substance LAB Sulfonic Acids do not have mutagenic or clastogenic potential in vivo.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
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:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not examined
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No significant differences in the incidence of chromosomal aberrations were observed in any test substance treatment group relative to the controls.

Chromosome Aberrations

 

Total number of cells having aberrations and occurrence (%)

 

6 hrs

24 hrs

48 hrs

5 days

200 mg/kg

0 (0)

0 (0)

0 (0)

1 (0.7)

400 mg/kg

1 (0.7)

0 (0)

0 (0)

0 (0)

800 mg/kg

0 (0)

0 (0)

0 (0)

0 (0)

800 mg/kg of 17.1% detergent

0 (0)

0 (0)

0 (0)

-

1600 mg/kg of 17.1% detergent

0 (0)

1 (0.7)

0 (0)

-

3200 mg/kg of 17.1% detergent

2 (1.3)

2 (1.3)

0 (0)

-

1000 mg/kg of 19% detergent

-

0 (0)

-

-

2000 mg/kg of 19% detergent

-

0 (0)

-

-

4000 mg/kg of 19% detergent

-

0 (0)

-

-

Mitomycin C

16 (10.7)

53 (353)

13 (8.7)

112 (74.7)

Distilled water

0 (0)

0 (0)

0 (0)

0 (0)

untreated

0 (0)

0 (0)

1 (0.7)

0 (0)

Conclusions:
Interpretation of results (migrated information): negative
The test substance is not clastogenic.
Executive summary:

Groups of male mice were given doses of 200, 400, or 800 mg/kg of Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts. At 6, 24, and 48 hrs, 3 of the mice from each dosage group were sacrificed. The bone marrow cells from the femurs were collected and examined for chromosome aberrations. In addition, one group of mice was exposed daily for 5 consecutive days. Additional groups of mice were exposed to commerical detergents containing 19% or 17.1% of the test substance. Mitomycin C was used as a positive control. None of the treatment groups showed any significant increase in chromosome aberrations as compared to negative controls. The test substance in not clastogenic.

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Negative controls validity:
valid
Additional information on results:
No increase in chromosome aberrations was noted.

Chromosome Aberrations

 

0.9% in Diet

Control

No. of cells with chromatid breaks

1

2

No. of cells with isochromatid breaks

1

0

No. of cells with chromatid gaps

4

5

No. of cells with isochromatid gaps

0

0

No. of cells with other aberrations

0

0

Conclusions:
Interpretation of results (migrated information): negative
The test substance is not clastogenic.
Executive summary:

A group of 5 male mice was fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Negative controls validity:
valid
Additional information on results:
No increase in chromosome aberrations was noted.

Chromosome Aberrations

 

0.9% in Diet - Wister Rats

0.9% in Diet -

SD Rats

Control

Control

No. of cells with chromatid breaks

0

0

1

0

No. of cells with isochromatid breaks

0

0

0

0

No. of cells with chromatid gaps

3

4

3

4

No. of cells with isochromatid gaps

0

0

0

0

No. of cells with other aberrations

0

0

0

0

Conclusions:
Interpretation of results (migrated information): negative
The test substance is not clastogenic.
Executive summary:

Groups of 5 male rats were fed a diet containing 0.9% test substance for 9 months. At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to controls. The test substance is not clastogenic.

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see read-across document
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Negative controls validity:
valid
Additional information on results:
There were no significant differences in fertility, the mortality of ova and embryos, the number of surviving fetuses, or the index of dominant lethal induction between the experimental groups and the control group.

Dominant Lethal Assay Results

 

0.6% in Diet

Control

Number of mating females

14

18

Number pregnant

11

12

No. with dead embryos

6

10

Dead embryos per pregnant female

54.6%

83.3%

No. of corpora lutea

156

161

Corpora lutea per pregnant female

14.2

13.4

No. of implants

148

156

Implants per pregnant female

13.5

13.0

Implants per corpora lutea

94.9

96.9

No. of live fetuses

142

143

Live fetuses per pregnant female

12.9

11.9

Live fetuses per corpora lutea

91.0

88.8

Live fetuses per total implants

96.0

91.7

No. of early dead fetuses

4

12

No. of late dead fetuses

2

1

% of dominant lethals

-4.67

-

% of dominant lethals

-8.33

-

Conclusions:
Interpretation of results (migrated information): negative
The test substance did not cause genetic disorders in mice.
Executive summary:

A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined. No increase in dominant lethal induction was seen as compared to controls. The test substance does not cause genetic disorders.

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

Additional information

Additional information from genetic toxicity in vivo:

A series of in vivo mutagenicity studies are available. In the first study, 40 male and 40 female mice were given a single oral dose by gavage of 1122 mg/kg of the read-across substance LAB Sulfonic Acid and evaluated for chromosome aberrations. Only a single dose has been evaluated which was in the range of the acute oral LD50 value for LAB Sulfonic Acid in rats (LD50 = 1470 mg/kg). Furthermore, slight cytotoxicity has been observed after 48 hours. No statistically significant or biologically relevant increases in the number of polychromatic erythrocytes with micronuclei were observed; therefore the test material is considered negative for cytogenicity.

In an in vivo mammalian chromosome aberration study on LAS (read across) by Inoue et al. 1976, groups of male mice were given doses of 200, 400, or 800 mg LAS/kg. This is about half the acute oral LD50 of 1655 mg/kg, as cited by the authors of the study. Mice were sacrificed at 6, 24, and 48 hrs, three of the mice from each dosage group were sacrificed, and bone marrow cells from the femurs collected and examined for chromosome aberrations. In addition, one group of mice was exposed daily for 5 consecutive days. Additional groups of mice were exposed to commercial detergents containing 19% or 17.1% of LAS. None of the treatment groups showed any significant increase in chromosome aberrations as compared to negative controls while the positive control, Mitomycin C, clearly showed an increase in chromosomal aberration frequency. Therefore, the read-across substance was not considered clastogenic in this assay.

A second chromosomal aberration study on LAS (read across) was conducted by Masubuchi et al. 1976. In this study, groups of five male mice or five male rats were fed diets containing 0.9% LAS for 9 months (1125 mg/kg bw/d for mice, 405 mg/kg bw/d for rats). At the end of this period, the animals were sacrificed, and the bone marrow cells examined for chromosome aberrations. No increase in chromosome aberrations was seen as compared to negative controls in either species but no positive controls have been included in this assay. The read-across substance LAS was not clastogenic in this assay.

These same authors (Masubuchi et al. 1976) also conducted a dominant lethal study in mice. A group of seven male mice were fed a diet containing 0.6% of the read-across substance LAS for 9 months (750 mg/kg bw/d). At the end of this period they were each mated with two untreated females. Females were sacrificed on day 13 of gestation for examination of ovaries and uteri. No evidence of dominant lethal mutations was observed as compared to the controls.

Justification for classification or non-classification