Registration Dossier

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:
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:
OECD Guideline 417 (Toxicokinetics)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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:
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.