Registration Dossier
Registration Dossier
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EC number: 223-989-2 | CAS number: 4156-21-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other:
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement based on toxicity studies and phys-chem data
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Objective of study:
- other: ADME
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Physical-chemical data as well as findings from toxicologic studies were evaluated with regard to kinetic information.
- GLP compliance:
- no
- Remarks:
- not required
Test material
- Reference substance name:
- Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate
- EC Number:
- 223-989-2
- EC Name:
- Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate
- Cas Number:
- 4156-21-2
- Molecular formula:
- C9H6Cl2N4O3S.Na
- IUPAC Name:
- sodium 4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- substance is expected to be readily absorbed
- Type:
- distribution
- Results:
- Substance is expected to be systemically available
- Type:
- metabolism
- Results:
- substance is expected to be inactivated mainly by hydrolysis
- Type:
- excretion
- Results:
- substance is expected to be eliminated quickly by the kidneys
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Granofin easy is soluble in water and octanol. Via its local corrosive effects the substance can destroy the natural barriers of mucous membranes. Therefore it is expected to be readily bio-available at the portal of entry and also in systemic circulation. This notion is supported by the observed systemic toxicity in several test systems.
- Details on distribution in tissues:
- Due to the good solubility of the substance, ready systemic distribution beyond the portal of entry is expected. The substance is not expected to accumulate in fatty tissues.
- Details on excretion:
- Granofin easy as well as the expected hydrolysis products are soluble in water, ready excretion in mammals is expected via the kidney.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Significant metabolism is expected due to the intended reactivity of the chlorinated triazine moiety with nucleophils like water or proteins. The main expected reaction is an inactivation by hydrolysis.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: no bioaccumulation is expected due to the solubility in water and the low partition coefficient (logPow)
The test substance is expected to be readily absorbed and distributed in organisms. Metabolism via hydrolytic inactivation of the chlorinated triazine is expected to be the main path. Quick excretion is expected to occur via the kidneys - Executive summary:
The test material has the chemical structure of sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)-amino]-benzene-sulphonate. The pH-Value of aqueous solutions is almost neutral. Due to the presence of a sulfonic acid salt moiety the substance is polar and well soluble in water. The partition coefficient was determined as -0.48, which means that the substance is about 10 times as soluble in water compared to octanol. The substance is used in leather tanning as a tanning agent und textile fiber treatment. The mechanism of this action most probably is based on the ability to bind covalently to fibers and crosslink proteins.
The material is corrosive in vivo to mucous membranes.
Absorption: Granofin easy is soluble in water and octanol. Via its local corrosive effects the substance can destroy the natural barriers of mucous membranes. Therefore it is expected to be readily bio-available at the portal of entry and also in systemic circulation. This notion is supported by the observed systemic toxicity in several test systems.
Distribution: Due to the good solubility of the substance, ready systemic distribution beyond the portal of entry is expected. The substance is not expected to accumulate in fatty tissues.
Metabolism: Granofin easy has a molecular weight about 414 Dalton and is easily soluble at physiologic pH. Significant metabolism is expected due to the intended reactivity of the chlorinated triazine moiety with nucleophils like water or proteins. The main expected reaction is an inactivation by hydrolysis.
Excretion: Granofin easy as well as the expected hydrolysis products are soluble in water, ready excretion in mammals is expected via the kidney.
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