Registration Dossier
Registration Dossier
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EC number: 608-544-6 | CAS number: 3082-64-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- Details on test material:
- - Name of test material: (S)-1-Phenylpropylamin (CAS 3789-59-1)
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.5, 5, 15 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females per dose and control group
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral administration of the test substance to rats for a period of twenty-eight consecutive days at dose levels of 1.5, 5 and 15 mg/kg/day produced no toxicologically significant changes in the parameters measured. The No Observed Effect Level (NOEL) was considered to be 15 mg/kg/day .
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