Benzeneacetic acid, .alpha.-hydroxy-, (.alpha.R)-(1R,2S)-compd. with 2-(3,4-difluorophenyl)cyclopropanamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Principles of method if other than guideline:

Annex V to Council Directive 67/548/EEC on the approximation

of laws, regulations and administrative provisions relating

to the classification, packaging and labelling of dangerous

substances, published in the Seventeenth Adaptation,
Commission Directive 92/69/EEC, OJEC L383A, 113-116, 1992.
(B.1 bis Acute Toxicity (Oral) Fixed Dose Method).

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

454-140-6

EC Name:

-

Cas Number:

376608-71-8

Molecular formula:

C9H9F2N*C8H8O3

IUPAC Name:

(1R)-2-(3,4-difluorophenyl)cyclopropan-1-aminium (2R)-2-hydroxy-2-phenylacetate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Rat - Wistar (Alpk:APfSD)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% w/v aqueous carboxymethylcellulose

Doses:

Dose 300mg/kg 50 mg/kg

Number animals 1 5

No. of animals per sex per dose:

Preliminary sighting study: 0 (male)
Preliminary sighting study: 1 (female)
Main study: 0 (male)
Main study: 5 (female)

Details on study design:

Main study:
50 mg/kg

Results and discussion

Preliminary study:

Species/strain: Rat - Wistar (Alpk:APfSD)
300 mg/kg bw: Evident toxicity: Y; Mortality: Y

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

50 mg/kg bw

Remarks on result:

other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5

Clinical signs:

other: Signs of toxicity: No deaths. Signs of toxicity on day 1 only.

Gross pathology:

Effects on organs:
None

Other findings:

Dose 300mg/kg 50 mg/kg

Number animals 1 5

sex female female

mortality 1 0


Clinical signs :

prostration splayed gait

tremors Piloerection, lacrymation

cyanosis Salivation, stained nose,

reduced splay reflex


Gross necropsy :

no macroscopic no macroscopic

effects effects

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information