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Toxicological information

Genetic toxicity: in vivo

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.