Registration Dossier
Registration Dossier
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EC number: 234-217-9 | CAS number: 10599-90-3
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Mucosal ulcerogenic action of monochloramine in rat stomachs effects of polaprezinc and sucralfate
- Author:
- Kato S., Nishiwaki H., Akira Konaka A. and Takeuchi K.
- Year:
- 1 997
- Bibliographic source:
- Digestive diseases and sciences, vol. 42, no. 10, pp. 2156-2163.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The animals were administered the tested substance orally by esophageal intubation, and killed one hour later.
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- acute toxicity: oral
Test material
- Reference substance name:
- Chloramide
- EC Number:
- 234-217-9
- EC Name:
- Chloramide
- Cas Number:
- 10599-90-3
- Molecular formula:
- ClH2N
- IUPAC Name:
- chloranamine
- Details on test material:
- - Name of test material (as cited in study report): monochloramine
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Shizuoka, Japan.
- Age at study initiation:
- Weight at study initiation: 250-300 g
- Fasting period before study: Rats were deprived of food for 18 hr prior to the experiments.
- Housing: individual cage
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The animals were administered 1 ml of NH2Cl (20, 60, and 120 mM), orally by esophageal intubation.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 1 hour
- Frequency of treatment:
- one administration
- Post exposure period:
- No
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 60, 120 mM (4.1, 12.4, and 24.7 mg/kg)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4 to 6
- Control animals:
- yes
Examinations
- Examinations:
- - Gastric Mucosal damage was observed.
- Lipid peroxidation was determined. - Positive control:
- None
Results and discussion
- Details on results:
- NH2Cl generated from a reaction of NaClO with NH4OH, produced severe hemorrhagic lesions in the rat stomach at the concentration of 60 mM or greater. In addition, intragastric administration of NH2Cl (120 mM) caused multiple bandlike lesions in the gastric mucosa, the lesion score being 128.2 +/- 19.6 mm2.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, monochloramine unduced gastric lesions.
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