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

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study according to scientific practice using radiolabelled material

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Objective of study:

absorption

distribution

excretion

toxicokinetics

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 417 (Toxicokinetics)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C10-18-alkane, sodium salts

EC Number:

268-213-3

EC Name:

Sulfonic acids, C10-18-alkane, sodium salts

IUPAC Name:

sulfonic acids, C10-18-alkane, sodium salts

Constituent 2

Reference substance name:

Hostapur SAS-14C

IUPAC Name:

Hostapur SAS-14C

Constituent 3

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

Details on test material:

- Name of test material (as cited in study report): Hostapur SAS - 14C
- Physical state: solid
- Analytical purity: 100 %
- Impurities (identity and concentrations): no
- Composition of test material, percentage of components: 100 %
- Isomers composition: n.a.
- Purity test date: 1976-01-16
- Lot/batch No.: 5110 I
- Expiration date of the lot/batch: 1979-12-31
- Radiochemical purity (if radiolabelling): 100 %
- Specific activity (if radiolabelling): 4.15 mCi/g
- Locations of the label (if radiolabelling): uniform (every carbon) U-C14 radiolabelled
- Expiration date of radiochemical substance (if radiolabelling): 1977-12-31
- Stability under test conditions: stable
- Storage condition of test material: refrigerator, darkness
- Other:

Radiolabelling:

yes

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ivanovas (Kißlegg, Allgäu, Germany)
- Weight at study initiation: 180 - 240 g
- Fasting period before study: 12 hours befor application, 4 hours after application
- Housing: individually
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): see above
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: For oral administration aqueous solutions of 0.12 mg/mL, 1.0 mg/mL and 10.5 mg/mL were used
HOMOGENEITY AND STABILITY OF TEST MATERIAL: guaranteed

Duration and frequency of treatment / exposure:

single administration

Doses / concentrations

Remarks:

Doses / Concentrations:
0.51 mg/kg, 5.3 mg/kg, 51 mg/kg

No. of animals per sex per dose / concentration:

6 male animals per group, 3 groups of animals

Control animals:

other: from untreated animals and from same animals befor treatment

Details on study design:

- Dose selection rationale: expert judgement
- Rationale for animal assignment (if not random): random

Details on dosing and sampling:

PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, cage washes, air (CO2), kidneys, gonads, liver, heart, lung, muscle, suet, bone marrow,
- Time and frequency of sampling: 2h up to 7 days
- Other:

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

moderate absorption

Details on distribution in tissues:

at or below detection limit

Details on excretion:

rapid

Metabolite characterisation studies

Metabolites identified:

not measured

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Pharmacokinetic parameter (absorption, distribution, elimination) independent of administerd dose

Executive summary:

After single oral application of 0.5, 5.3 or 51 mg sec-alkane sulfonate-sodium salt SAS - 14C via gavage to 3 groups of 6 male rats per group, blood levels reached a maximum about 2 to 6 hours after administration. Elimination from the blood was biphasic with biological half lifes of 11 and 65 hours. Up to 17 % of the administered radioactivity was exhaled as CO2; approximately 30 % was excreted via urine and about 45 % with faeces. In total more than 90 % of the applied radioactivity was excreted within the first 24 hours after application. Indications of bioaccumulation were not revealed as demonstrated by very low residual radioactivity ( < 1 ppm) in organs after 7 days.