Registration Dossier
Registration Dossier
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EC number: 204-539-4 | CAS number: 122-39-4
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- The chronic toxicity of diphenylamine for dogs
- Author:
- Thomas JO, Ribelin WE, Wilson RH, Keppler DC & Deeds F
- Year:
- 1 967
- Bibliographic source:
- Toxicol Appl Pharmacol; 11: 184-194
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- 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
- Details on test material:
- - Name of test material (as cited in study report): diphenylamine
- Analytical purity: 99.9%
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 737 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.01, 0.1 & 1%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 2 dogs/sex/dose
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: daily
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on days 224, 395, 591 & 724
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 730
URINALYSIS: Yes
- Time schedule for collection of urine: eight 24-hr collections/dog between day 692 and day 732 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN
0.1 & 1%: growth arrest
HAEMATOLOGY
0.1 & 1%: anemia
CLINICAL CHEMISTRY
1%: decreased resistance of eruthrocytes to hypotonicity
GROSS PATHOLOGY
1%: peripherolobular fatty change in the liver, marked increase in liver weight
HISTOPATHOLOGY: NON-NEOPLASTIC
1%: moderate degree of liver damage
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: growth inhibition; gross pathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No evidence of toxicity to dogs was encountered during continued feeding of 0.01% DPA diets for 2 years, corresponding to a total consumption of 1.54 g/kg. The derived NOAEL value is thus 2 mg/kg/day.
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