Registration Dossier
Registration Dossier
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EC number: 218-817-8 | CAS number: 2243-62-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP study. Only bw. and mortality examined.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Bioassay of 1,5-Naphthylenediamine for possible carcinogenicity; CAS No. 2243-62-1; NCI-CG-TR-143
- Author:
- National Cancer Institute (NCI)
- Year:
- 1 978
- Bibliographic source:
- National Cancer Institute; CARCINOGENESIS; Technical Report Series, No. 143, 1978
Materials and methods
- Principles of method if other than guideline:
- Method: other: dose-finding study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,5-naphthylenediamine
- EC Number:
- 218-817-8
- EC Name:
- 1,5-naphthylenediamine
- Cas Number:
- 2243-62-1
- Molecular formula:
- C10H10N2
- IUPAC Name:
- 1,5-naphthylenediamine
- Reference substance name:
- 1,5- naphthylenediamine
- IUPAC Name:
- 1,5- naphthylenediamine
- Details on test material:
- IUCLID4 Test substance: other TS: purity 89-90 % (chromatography indicated an impurity)
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- continuously in diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.03, 0.1, 0.3, 1.0 or 3.0 % (ca. 43, 143, 429, 1429 or 4286 mg/kg/d)
Basis:
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent no treatment
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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Basis for effect level:
- other: see: executive summary
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
in all groups receiving 0.3 % or more deaths occurred and
also in females applied 0.03 %; in the group receiving 0.3 %
mean body weight depression was 22 % in males and 3 % in
females; males receiving 0.1 % showed a mean body weight
depression of ca. 3 %, while the females had a greater body
weight than the controls
Applicant's summary and conclusion
- Executive summary:
In order to establish the maximum tolerated concentrations of the test substance for administration to dosed animals in a chronic study, a subchronic toxicity study was conducted with B6C3F1 mice of both sexes.
The concentrations used were: 0,03; 0,1; 0,3; 1,0 and 3,0 %. The dosed dietary preparations were administered for 8 weeks.
Deaths were recorded for all groups of mice receiving concentrations of 0,3 % or more (no Nr. of animals given).
Mean body weight depression was approximately 22 and 3 %, respectively, in males and females dosed with 0,3 % of test substance.
Males receiving 0,1 % experienced mean body weight depression of approximately 3 %.
The concentration of test substance selected as highest dose group for the in the mouse chronic bioassay was 0,2 %.
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