Registration Dossier
Registration Dossier
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EC number: 204-539-4 | CAS number: 122-39-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The nephrotoxicity of diphenylamine, the parent compound of the mefenamate family of nonsteroidal anti-inflammatory drugs, was evaluated in male Syrian hamsters, male Sprague-Dawley rats, and male Mongolian gerbils
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Diphenylamine
- EC Number:
- 204-539-4
- EC Name:
- Diphenylamine
- Cas Number:
- 122-39-4
- Molecular formula:
- C12H11N
- IUPAC Name:
- diphenylamine
Constituent 1
Test animals
- Species:
- other: Hamster, Rat, Gerbil
- Strain:
- other: Syrian, Sprague-Dawley, Mongolian
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (Hamsters)
- Source: Harlan Sprague-Dawley, Indianapolis, IN
- Weight at study initiation: 80-120 g
- Housing: 5 animals/box with wood shavings for bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d
TEST ANIMALS (Rats)
- Source: Harlan Sprague-Dawley, Indianapolis, IN
- Weight at study initiation: 150-175 g
- Housing: 5 animals/box with wood shavings for bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d
TEST ANIMALS (Gerbils)
- Source: Tumblebrook Farms, West Brookfield, MA),
- Weight at study initiation: 45-55 g
- Housing: 5 animals/box with wood shavings for bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS (all)
- Temperature (°C): 22
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- other: oral gavage and intraperitoneal injection
- Vehicle:
- peanut oil
- Doses:
- Experiment 1: 400, 600 and 800 mg/kg bw/day (single daily gavage)
Experiment 2: 400, 600 and 800 mg/kg bw/day (single daily ip injection) - No. of animals per sex per dose:
- Experiment 1: 10 animals/dose + 10 animals in a control group
Experiment 2: 10 animals/dose + 5 animals in a control group - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 3 consecutive days of administration + 24 hr observation
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 600 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: Syrian hamsters
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 800 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: Sprague-Dawley rats
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 800 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: Mongolian gerbils
- Mortality:
- Experiment 1
- Syrian hamsters: 4/10 (400 mg/kg/d) and 10/10 (600 and 800 mg/kg/d)
-Sprague-Dawley rats and Mongolian gerbils: no mortality
Experiment 2:
- Syrian hamsters: 0/10 (400 mg/kg/d), 5/10 (600 mg/kg/d) and 4/10 (800 mg/kg/d) - Clinical signs:
- other: other:
- Gross pathology:
- Syrian hamsters: brown kidneys and yellow-brown papilla at the highest doses
Sprague-Dawley rats: no significant lesions
Mongolian gerbils: no gross lesions
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Syrian hamster is more susceptible to the papillotoxic effects of diphenylamine than the Sprague-Dawley rat and the Mongolian gerbil.
The male Syrian hamster may prove useful as an alternative experimental rodent model of non-steroidal, anti-inflammatory, drug-induced papillary necrosis
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