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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not applicable.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The data are mainly obtained by secondary source, therefore the information is limited.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2002
Reference Type:
publication
Title:
Unnamed
Year:
1996

Materials and methods

Objective of study:
distribution
excretion
Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 417 (Toxicokinetics)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in studies):Chloramine T or Tosylchloramide sodium (purity n.p.)
- Molecular formula: C7-H8-Cl-N-O2-S.Na
- Molecular weight: 227,64375 g/mol
- Smiles notation: S(=O)(=O)(c1ccc(cc1)C)[N-]Cl.[Na+]
- InChl: 1S/C7H7ClNO2S.Na/c1-6-2-4-7(5-3-6)12(10,11)9-8;/h2-5H,1H3;/q-1;+1
- Structural formula attached as image file: see Fig.
- Substance type: Biocide, disinfectant


Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
other: intravenous and oral
Doses / concentrations
Remarks:
Doses / Concentrations:
Martínez et al, 1996:
-Group 1: Single dose – 30 mg/kg bw i.v.
-Group 2: Single dose – 100 mg/kg bw p.o.
Details on dosing and sampling:
Martínez et al, 1996:
-Sampling time Serial blood samples
-Body fluids sampled Group 1 and 2: Blood
- Tissues

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Distribution half-life: 0.12 hr (after i.v. dosing)
0.42 hr (after p.o. dosing)
Details on distribution in tissues:
See table 2
Toxicokinetic parametersopen allclose all
Test no.:
#1
Toxicokinetic parameters:
half-life 1st: 1.41 hr (after i.v. dosing)
Test no.:
#2
Toxicokinetic parameters:
half-life 1st: 1.98 hr (after p.o. dosing)
Test no.:
#3
Toxicokinetic parameters:
other: Volume of distribution at steady state: 0.24 L

Metabolite characterisation studies

Metabolites identified:
no

Any other information on results incl. tables

Table 1   Excretion of HO36Cl in ratsa

Collection period (h)

Proportion of HO36Cl excreted (%)

 

Urine

Faeces

Total

 

 

 

 

0-8

1.71±1.03

 

 

8-16

2.36±0.52

 

 

16-24

2.99±0.03

 

 

 

 

 

 

0-24

7.05±1.51

7.45±0.95

14.50±0.56

 

 

 

 

24-48

12.22±2.12

2.85±0.25

15.00±1.87

48-72

10.02±0.40

1.60±0.30

11.62±0.10

72-96

7.14±1.64

2.90±2.20

10.04±0.56

 

 

 

 

0-96

36.43±5.67

14.80±3.70

51.23±1.97

 

 

 

 

aValues represent mean±SE from four treated (fasted) rats, expressed as the proportion of administration dose. 36Cl was not detected in expired air throughout the 96 h studied.

Table 2   The distribution of 36Cl activity 96 h after administration of HO36Cl orally

Tissue

36Cl activity (µg/g)

 

 

Plasma

1.92

Blood

1.59

Bone marrow

1.55

Testes

1.26

Skin

1.20

Kidney

1.13

Lung

1.04

Packed cells

1.03

Duodenum

0.71

Stomach

0.70

Spleen

0.67

Thyroid

0.66

Thymus

0.55

Liver

0.51

Carcass

0.40

Ileum

0.26

Fat

0.09

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
In the rat, tosylchloramide sodium is rapidly distributed throughout the body. Plasma clearance is relatively rapid, with elimination primarily through the urine. After 96 h, 36% was eliminated via the urine, whereas 15% was eliminated via faeces.
Executive summary:

Toxicokinetics of Chloramine-T after single 30 mg/kg i.v. and 100 mg/kg p.o. were studied in male Wistar Rats. Serial blood samples were collected and plasma concentrations of Chloramine-T were determined by HPLC method. Chloramine-T was characterized by a rapid distribution and elimination phase (distribution half-life 0.12 hr – i.v. and 0.42 hr. – p.o.; elimination half-life 1.41 hr – i.v. and 1.98 hr – p.o.). Plasma clearance was relatively high (0.147 L/hr – i.v., 0.149 L/hr – p.o.) with a volume of distribution at steady state of 0.24 L. Chloramine-T was found to be rapidly distributed and eliminated. After 96 h, 36% was eliminated via the urine, whereas 15% was eliminated via faeces.