Registration Dossier
Registration Dossier
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EC number: 944-110-5 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
- EC Number:
- 210-042-3
- EC Name:
- 4-[[4-(dimethylamino)phenyl][4-(methylimino)cyclohexa-2,5-dien-1-ylidene]methyl]-N,N-dimethylaniline monohydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water
- Details on oral exposure:
- gavage tube
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/dayMale: 5 animals at 50 mg/kg bw/dayMale: 5 animals at 200 mg/kg bw/dayMale: 10 animals at 1000 mg/kg bw/dayFemale: 10 animals at 0 mg/kg bw/dayFemale: 5 animals at 40 mg/kg bw/dayFemale: 5 animals at 200 mg/kg bw/dayFemale: 10 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- no mortaliity was observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- no mortaliity was observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Details on results:
- No mortalities occurred. Dark coloured feces were observed at 200 and 1000 mg/kg up to the 4th day of observation. No other clinical signs were noted.Body weight: At 1000 mg/kg males had a gain loss during treatment with the substance. No effect was observed during the observation.Food consumption: No substance related effect at 50, 200 and 1000 mg/kgGripping properties were normal together with the movement at 50, 200 and 1000 mg/kg.Hematologie/Biochemistry/Urinalysis:At 1000 mg/kg a light increase in the reticulocytes number was observed for males, together with the metahaemoglobine, leucocytes, lymphocites increase for males and females.At 200 and 1000 mg/kg an increase of the albumine content and total proteins was observed.Organ weight: no effectsMicroscopic and macroscopic observations:at 1000 mg/kg: -kidneys, increase of the hyaline droplets for males-stomach: erosion of the non glandular stomach associated to inflammatory lesions together with hyperkeratinosis and une hyperplasia for one femalelungs: interstitial fibrosys for two females that for one animal was associated to pigment deposit
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance was tested for repeated oral toxicity following OECD 407. Under the experimental conditions the NOAEL is 50 mg/kg bw /day.
- Executive summary:
The substance was tested for repeated oral toxicity following OECD 407. Under the experimental conditions the NOAEL is 50 mg/kg bw /day.
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