Sulfonic acids, C14-17-sec-alkane, sodium salts

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline study, not according to GLP. Conducted according accepted scientific standards. Well conducted and reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

in vivo

Deviations:

yes

Remarks:

no concurrent positiv control

GLP compliance:

no

Remarks:

not required at time of performance

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

EC Number:

307-055-2

EC Name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

Cas Number:

97489-15-1

Molecular formula:

H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3

IUPAC Name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

Constituent 2

Reference substance name:

Hostapur SAS 60

IUPAC Name:

Hostapur SAS 60

Details on test material:

- Name of test material (as cited in study report): Hostapur SAS 60
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: pasty
- Analytical purity: 60%
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breeding (Hoe:NMRKf(SPF71))
- Age at study initiation: 4 - 9 weeks
- Weight at study initiation: 23.6-28.9 g (male animals), 21.2-26.8 g (female animals)
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours


IN-LIFE DATES: From: 1974-07-15 To: 1974-07-23

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: solubility
- Concentration of test material in vehicle: corresponding to 600, 1200, 2400 mg/kg body weight
- Amount of vehicle (if gavage or dermal): 20 mL/kg body weight
- Type and concentration of dispersant aid (if powder): n.a.
- Lot/batch no. (if required): no data
- Purity: 60% active matter

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: freshly prior to application by gavage

Duration of treatment / exposure:

n.a. (gavage treatment)

Frequency of treatment:

2 times within 24 hours

Post exposure period:

6 hours (after second treatment)

Doses / concentrations

Remarks:

Doses / Concentrations:
600, 1200, 2400 mg/kg body weight
Basis:
nominal conc.

No. of animals per sex per dose:

5 male + 5 female mice per group

Control animals:

yes, concurrent vehicle

Positive control(s):

Strain of mice used known to respond to Cyclophosphamid as positive control

Examinations

Tissues and cell types examined:

bone marrow preparation from femur

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: Expert judgement


TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Treatment = 2 times within 24 hours, sampling 6 hours later

DETAILS OF SLIDE PREPARATION: according to published methodology


METHOD OF ANALYSIS: erythrocyte count


OTHER:

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Sec-alkane sulfonate-sodium salts SAS (60%) is not mutagenic in the micronucleus assay in vivo

Executive summary:

In a micronucleus-test in vivo groups of 5 male and 5 female NMRI-mice were administered sec-alkane sulfonate-sodium salts SAS (60%) orally by gavage at dose levels of 0 (control), 600, 1200 or 2400 mg/kg body weight. The animals were treated twice in an interval of 24 hours and sacrificed 6 hours after the last application. All animals of the high-dose group died after the second application. In the mid and low dose groups the incidence of micronucleated polychromatic erythrocytes was not increased in comparison with controls. On the basis of the results obtained, sec-alkane sulfonate-sodium salts SAS (60%) was not mutagenic in the micronucleus-test in NMRI-mice.