Registration Dossier

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:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: (S)-1-Phenylpropylamin (CAS 3789-59-1)

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 .