Registration Dossier
Registration Dossier
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EC number: 682-678-3 | CAS number: 182121-12-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- other: EFSA/AFC/FCM/1033-Rev. IIA/39815 from May 2007
- Adequacy of study:
- supporting study
- Study period:
- 90-days, repeated dose
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- 16th List of FCM substances
- Author:
- EFSA
- Year:
- 2 007
- Bibliographic source:
- EFSA/AFC/FCM/1033-Rev.IIA/39815 of May 2007
Materials and methods
- Principles of method if other than guideline:
- Review article: 90-day oral toxicity study in rats mentioned
- GLP compliance:
- not specified
Test material
- Specific details on test material used for the study:
- 9,9-Bis(methoxymethyl)fluorene
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- 90-days
- Frequency of treatment:
- repeated dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 other: mg/kg bw/day (unspecified)
- Remarks:
- maximum dose
- Dose / conc.:
- 250 other: mg/kg bw/day (unspecified)
- Dose / conc.:
- 74 other: mg/kg bw/day (unspecified)
- Remarks:
- minimum dose
- Remarks:
- other doses not mentioned
Examinations
- Observations and examinations performed and frequency:
- no histopathological changes found
at 750 mg/kg bw/day: increase in relative liver weight, changes in clinicla chemistry (ketonuria),
at 250 mg/kg bw/day: changes in clinicla chemistry (ketonuria)
NOEL from this study: 74 mg/kg bw/day
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:
- not specified
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- changes in clinicla chemistry (ketonuria) at 750 mg/kg bw/ day and 250 mg/kg bw/day
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- ketonuria at 750 mg/kg bw/ day and 250 mg/kg bw/day
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increases in relative liver weights at 750mg/kg bw/day
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- no histopathological findings even at top dose
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- no histopathological findings even at top dose
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 74 other: mg/kg bw/day (not specified)
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: data from review
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In this review article a 90-day repeated-dose oral toxicity study in rats is mentioned. At the highest dose of 750 mg/kg bw/day an increases of liver weights were observed. At 750 and 250 mg/kg bw/day changes in clinicla chemistry (kezonuria) occured.
A NOAEL is derived: 74 mg/kg bw/day
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