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EC number: 203-581-0 | CAS number: 108-42-9
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- REPDOSE: A database on repeated dose toxicity studies of commercial chemicals—A multifunctional tool
- Author:
- Bitsch,S.Jacobi,C.Melber,U.Wahnschaffe,N. Simetska,I. Mangelsdorf
- Year:
- 2 006
- Bibliographic source:
- Regulatory Toxicology and Pharmacology Volume 46, Issue 3, December 2006, Pages 202–210;Repdose database-O'Neal FO (Haskell Laborat ory for Toxicolo gy and..)
Materials and methods
- Principles of method if other than guideline:
- A subacute study was conducted to evaluate the toxic effect of repeated administration of 3-chloroaniline to rats by the inhalative route.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-chloroaniline
- EC Number:
- 203-581-0
- EC Name:
- 3-chloroaniline
- Cas Number:
- 108-42-9
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 3-chloroaniline
- Details on test material:
- - Name of test material: 3-chloroaniline
- Substance type: Organic
- Physical state: Liquid
- Molecular formula :C6H6ClN
- Molecular weight :127.57
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 Days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8.800 mg/kg bw/d
Basis:
- Control animals:
- not specified
Examinations
- Observations and examinations performed and frequency:
- HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
OTHER: Organ Weight : Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- erythrocytes,extrame dullary haematopoiesis,haematocrit,haemoglobin,methaemoglobinaemia
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changed Enzyme activity
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- weight increased in spleen
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- congestion observed in spleen
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- haematopoiesis and haemosiderosis in spleen
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- LOEL
- Effect level:
- 8.8 other: mg/kg bw/d
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Effects observed on clinical chemistry,haematology,organ weights,gross and histopathology.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a repeated dose toxicity study of 3-chloroaniline, LOEL (Lowest onserved effect level) was considered to be 8.800 mg/kg bw/d when administered by inhalative route to rat.
- Executive summary:
In a repeated dose toxicity study, the toxic effects of repeated administration of 3-chloroaniline to rat by the inhalative route was evaluated. Rats were given 3-chloroaniline for 14 days at a dose concentration of 8.800 mg/kg bw/day. Changed Enzyme activity, in blood -erythrocytes,extramedullary haematopoiesis,haematocrit,haemoglobin and methaemoglobinaemia observed,as well as in spleen congestion,haematopoiesis,haemosiderosis and weight increased was observed.Therefore,LOEL(Lowest onserved effect level) for repeated dose toxicity study was considered to be 8.800 mg/kg bw/day for the 14 days study,it is regarded that there is no repeated dose toxicity at concentrations lower than 8.8 mg/kg bw/day when administered by inhalative route.
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