Registration Dossier
Registration Dossier
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EC number: 203-254-2 | CAS number: 104-94-9
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Interlaboratory comparison of the CB6F1-Tg rasH2 rapid carcinogenicity testing model
- Author:
- R.R. Maronpot, K. Mitsumori , P. Mann , M. Takaoka , S. Yamamoto , T. Usui , H. Okamiya , S. Nishikawa, T. Nomura
- Year:
- 2 000
- Bibliographic source:
- Toxicology 146 (2000) 149–159
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Carcinogenicity test was performed on CB6F1 males and female mice
- GLP compliance:
- no
Test material
- Reference substance name:
- p-anisidine
- EC Number:
- 203-254-2
- EC Name:
- p-anisidine
- Cas Number:
- 104-94-9
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 4-methoxyaniline
- Details on test material:
- Name of test material (as cited in study report): p- anisidine
- Molecular formula (if other than submission substance): C7-H9-N-O
- Molecular weight (if other than submission substance): 123.1541 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CB6F1-rasH2
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal and environmental conditions:
TEST ANIMALS
- Source: Central Institute for Experimental Animals (Kawasaki, Japan)
- Age at study initiation:≈6 week old
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: housed in polycarbonate cages (singly housed for males and 5:cage
for females) with absorbent hardwood bedding
- Diet (e.g. ad libitum): NIH-07 open formula diet (ad libitum)
- Water (e.g. ad libitum): (ad libitum)
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): continuous temperature monitoring.
- Humidity (%): continuous humidity monitoring.
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-h light:12-h dark cycle
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Feed
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): p-Anisidine admixed with feed at concentrations of 0.450 and 0.225%
- Mixing appropriate amounts with (Type of food): NIH-07 open formula diet
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 month period
- Frequency of treatment:
- daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
321.428 And 642.857 mg/kg(0.225 and 0.450%)
Basis:
no data
- No. of animals per sex per dose:
- 60 animal/sex/dose
- Control animals:
- yes
- Details on study design:
- Control animals: 40 animal/sex/dose
Examinations
- Observations and examinations performed and frequency:
- Observation and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data available
DETAILED CLINICAL OBSERVATIONS: No data available
DERMAL IRRITATION (if dermal study): No data available
- Time schedule for examinations: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: No data available
CLINICAL CHEMISTRY: No data available
URINALYSIS: No data available
NEUROBEHAVIOURAL EXAMINATION: No data available - Sacrifice and pathology:
- Scarifies And Pathology:
GROSS PATHOLOGY:
Yes
HISTOPATHOLOGY:
Yes - Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- 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:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Details on Result:
CLINICAL SIGNS AND MORTALITY:
Clinical signs: No clinical sighs observed in animals during study.
Mortality: all animals were necropsied.
BODY WEIGHT AND WEIGHT GAIN:
Body weight: In male decrease in body weight and in female only in low dose mice decrease in body weight observed.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available
FOOD EFFICIENCY: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: No data available
CLINICAL CHEMISTRY: No data available
URINALYSIS: No data available
NEUROBEHAVIOUR: No data available
ORGAN WEIGHTS: No data available
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: NON-NEOPLASTIC: Yes
HISTOPATHOLOGY: NEOPLASTIC (if applicable): No
HISTORICAL CONTROL DATA (if applicable): No
OTHER FINDINGS
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 642.857 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
- Conclusions:
- The endpoint for carcinogenicity was found to be No Observed Effect Level (NOEL) at 642.857 mg/kg concentration of p-anisidine (104-94-9).
- Executive summary:
Carcinogenicity test was performed on CB6F1 males and female at two different laboratories in Japan and USA. p-anisidine was mixed with feed and given to animals at two different concentrations as 321.428 and 642.857 mg/kg and observed 18 months for carcinogenicity effects. After 18 months all mice were necropsied and observed histopathologically. Standard hematoxylin and
Eosin-stained slides were also evaluated.
After 18 months no clinical effects were observed in male and female. Decrease in body weight in males and some females of low dose concentration were also observed. On gross pathology dark red spleens and small lung nodules in a few mice and no significant dose-related trends for either pulmonary or splenic tumors were observed. Some effects were also observed in control also.
So on the basis of above experimental results it was concluded that the endpoint for carcinogenicity was found to be No Observed Effect Level (NOEL) at 642.857 mg/kg concentration of p-anisidine (104-94-9).
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