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EC number: 307-055-2 | CAS number: 97489-15-1
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:
- 1 977
- 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
- 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
- Reference substance name:
- Hostapur SAS-14C
- IUPAC Name:
- Hostapur SAS-14C
- 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:
Constituent 1
Constituent 2
Constituent 3
- 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.
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