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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute 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: Guideline study conducted unter GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solution in olive oil DAB 10
Details on test material:
Name of test substance: 1-Phenylpropylamin
Substance number: 97/98
Batch number: K 67/ 11.2.97/ Fr. 5
CAS number: 2941-20-0
Degree of purity/content: 99.7 g/100 g (GC)
Date of manufacturing: 11-Feb-1997
Physical state/appearance: Liquid, colourless
Storage conditions: Room temperature, exclusion of oxygen (store
under nitrogen)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
200, 500, and 2000 mg/kg bw
No. of animals per sex per dose:
200 mg/kg bw: 3 male animals
500 mg/kg bw: 3 male animals
2000 mg/kg bw: 3 male and female animals
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 500 mg/kg bw
Mortality:
200 mg/kg bw: no mortality after 14 days
500 mg/kg bw: 3/3 found dead
2000 mg/kg bw: 3/3 found dead
Gross pathology:
animals that died: glandular stomach: severe hyperemia; small intestine: hyperemia of the mucosa

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the median lethal dose of (R)-1-Phenylpropylamin after oral application was found to be greater than
200 mg/kg and less or equal to 500 mg/kg body weight.
Executive summary:

To two groups each of three fasted animals (males) a single oral dose of the test material preparation in olive oil DAB 10 at dose levels of 500 and 2000 mg/kg body weight was given. Another group of six fasted animals (3 males and 3 females) was treated in the same way with a dose of 200 mg/kg body weight. Signs of toxicity noted in the 2000 and 500 mg/kg dose group comprised poor general state, dyspnoea, apathy, ataxia and paresis. Twitching, saltatory spasm and flexion spasm were additionally observed in rats of the 2000 mg/kg dose group. Symptoms observed in the 200 mg/kg dose group comprised impaired or poor general state, dyspnoea, apathy and staggering. The surviving animals appeared normal within 5 hours after application. The expected body weight gain was observed in the course of the study. All animals of the 500 and 2000 mg/kg dose group died within 1 hour after application. No mortality occurred in the 200 mg/kg dose group.

Necropsy findings of the animals that died comprised severe hyperemia in the glandular stomach and hyperemia of the mucosa in the small intestine (2000 mg/kg). No abnormalities were noted at necropsy of animals sacrificed at the end of the study and of the animals of the 500 mg/kg dose group that died. Under the conditions of this study the median lethal dose of (R)-1-Phenylpropylamin after oral application was found to be greater than 200 mg/kg and less or equal to 500 mg/kg body weight.