Registration Dossier
Registration Dossier
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EC number: 213-995-3 | CAS number: 1071-76-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- secondary data from authority reviewed summary
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- review article or handbook
- Title:
- n-Butanol
- Author:
- ECETOC
- Year:
- 2 003
- Bibliographic source:
- ECETOC JACC No. 41
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: other
- Principles of method if other than guideline:
- Four groups of male and female rats (30/sex/group) were administered daily by gavage 0, 30, 125 or 500 mg/kg bw/d for either 6 or 13 weeks.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 6 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Ataxia and hypoactivity (lasting less than 1 h) were observed 2 to 3 minutes after dosing in both sexes of the high-dose group (500 mg/kg bw/d) during the final 6 weeks of dosing.
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- other: no effects observed
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- central nervous system
- Organ:
- other: general effect on CNS
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- No treatment related signs were observed in the 30 or 125 mg/kg bw /d treatment groups, the latter value being the no-observed adverse effect level (NOAEL)
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