Registration Dossier
Registration Dossier
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EC number: 211-254-9 | CAS number: 636-30-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 14 days- Dose finding study; non-GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- 2,4,5-Trichloranilin - BUA-Bericht Nr 227
- Author:
- BUA
- Year:
- 2 001
- Bibliographic source:
- S. Hirzel Verlag Stuttgart, Germany 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Only a 14 day gavage study of orientating character, no clinical chemistry data. Organ weights only from liver, renals, spleen, testes and ovaries. Histological data only from liver and spleen.
- GLP compliance:
- no
- Remarks:
- Methods were identical to GLP studies but no inspection was performed
- Limit test:
- no
Test material
- Reference substance name:
- 2,4,5-trichloroaniline
- EC Number:
- 211-254-9
- EC Name:
- 2,4,5-trichloroaniline
- Cas Number:
- 636-30-6
- Molecular formula:
- C6H4Cl3N
- IUPAC Name:
- 2,4,5-trichloroaniline
- Details on test material:
- - Name of test material (as cited in report): 2,4,5-Trichloroaniline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Once daily at seven days a week.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60, 250 and 1000mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- This study was planned a dose range finder study for a subacute toxicity study.
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weight: Liver
HISTOPATHOLOGY: Yes, spleen and liver only
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced gain
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- increase
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- liver, spleen
- Histopathological findings: neoplastic:
- not specified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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