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Registration Dossier
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EC number: 238-687-6 | CAS number: 14639-97-5
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Tributyl Phosphate Effects on Urine and Bladder Epithelium in Male Sprague-Dawley Rats
- Author:
- Arnold et al.
- Year:
- 1 997
- Bibliographic source:
- FUNDAMENTAL AND APPLIED TOXICOLOGY 40, 247-255 (1997)
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- -Test Organisms:
a)Age: 4-5 weeks old
b)Source: Charles River Breeding Laboratories Inc.
(Kingston, NY)
c)Weight at study initiation: mean;175g
d)No. of animals per dose: 10 males
e)Feeding: Food (Purina Mills Certified Rodent Lab Chow) and
water were available ad libitum throughout the study.
f)Quarantine: The animals were quarantined for 12 days
before initiation of treatment.
-Test Conditions:
a)Temperature: 22 plus or minus 4 degree C
b)Humidity: 55 plus or minus 15%
c)Lightning: 12hr-light(07:00 to 19:00), 12hr-dark
d)Dose: 12300ppm in the diet
e)Positive Control: 3000ppm of Tributyl phosphate(TBP)
-Examinations:
a)Food consumption
b)Body weight
c)Urine analysis; pH, osmolality, Magnesium, Calcium,
Creatinine, Phosphate, Protein
d)Pathology: necropsy and bladder examination; bladder
weight, bladder histology (hyperplasia), Labeling index - GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- Molecular formula:
- ClH4N
- IUPAC Name:
- ammonium chloride
- Details on test material:
- Sigma Chemical, purity:>98.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 70 d
- Frequency of treatment:
- 7 days per week7
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
12300ppm in the diet (= 684 mg/kg bw day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Positive control:
- with Tributyl Phosphate
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- a)pH: ammonium chloride treatment reduced urinary pH to 6.04 (control:7.56) b)Calcium: significantly increased in the ammonium chloride treatment
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- moderate increase of bladder weight
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- -Histopathologic Examinations: a)Bladder weight(mean, g/kg bw): NH4Cl/0.260, Control/0.227, TBP/0.446 b)Bladder histology: (No.of Normal / Simple hyperplasia /Papillary or Nodular hyperplasia) NH4Cl; 10 / 0 / 0, Control; 10 / 0 / 0, TBP; 0 / 10 / 6 c)Labe
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 684 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL for NH4Cl was determined to be 684 mg/kg bw day
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