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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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