1-chloro-2,4-dinitrobenzene

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report, non-GLP, early study, one sex only;

Data source

Reference

Reference Type:

publication

Title:

Testing of twenty-one environmental aromatic amines or derivatives for long-term toxicity or carcinogenicity

Author:

Weisburger, E.K. et al.

Year:

1978

Bibliographic source:

J. Environ. Pathol. Toxicol. 2: 325-356 (1978)

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Animals were fed a diet containing the test material for 18 months. Afterwards they were observed for and additional recovery period and subsequently killed and tissues examined histopathologically.

GLP compliance:

no

Remarks:

pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-2,4-dinitrobenzene

EC Number:

202-551-4

EC Name:

1-chloro-2,4-dinitrobenzene

Cas Number:

97-00-7

Molecular formula:

C6H3ClN2O4

IUPAC Name:

1-chloro-2,4-dinitrobenzene

Details on test material:

purity: 97 - 99 %, commercial sample

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: 4 - 6 weeks

- Food: Standard diet ad libitum
- aclimation period: 2 weeks
- housing: groups of 5

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Details on exposure:

Stability in feed over 3 days was determined via extraction and chemical identification/quantification

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

18 months

Frequency of treatment:

daily

Post exposure period:

6 months

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
low
Basis:
other: 1000 ppm(diet, nominal) for 2 months; 250 for 3 months; 500 for 13 months; recovery for 6 months

Doses / concentrations 2

Remarks:

Doses / Concentrations:
high
Basis:
other: 2000 (diet, nominal) for 2 months; 500 for 3 months; 1000 for 13 months; recovery for 6 months

No. of animals per sex per dose:

25

Control animals:

yes, plain diet

Details on study design:

The dose level was changed several times due to observed/ no-observed effects on body weight

Positive control:

not required

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:


BODY WEIGHT: Yes
- Time schedule for examinations: no data ("carefully")


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
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data


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


WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:


OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY:No data

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes ; only in animals surviving > 6 months
HISTOPATHOLOGY: Yes : but no details reported

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

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:

effects observed, treatment-related

Details on results:

1-Chloro-2,4-dinitrobenzene was not tumorigenic in rats

Relevance of carcinogenic effects / potential:

The study provided no indication of an influence of the testmaterial on tumor incidence in male rats.

Effect levels

Dose descriptor:

NOAEL

Effect level:

ca. 1 028 ppm (nominal)

Sex:

male

Basis for effect level:

other: Although the dose level was changed due to (missing) effects on body weight, no details were reported

Remarks on result:

other: Effect type: carcinogenicity (migrated information)

Applicant's summary and conclusion

Conclusions:

1-Chloro-2,4-dinitrobenzene was not tumorigenic in rats