Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BONIFACE M. et B., CAZIN J.C et LUYCKX J. Calcul, sur ordinateur, de la dose efficace par la méthode des probits : Application au calcul d’une dose létale 50. Bull Soc. Pharm. Lille, 1972, 4, 187-185

CAZIN J.L. Exemples d’utilisation de micro-ordinateurs en génie biologique et médical (Apple II et III) Diplôme d’Etudes Approfondies de Génie Biologique et Médical. 1983, Faculté de Pharmacie de Lille.

BLISS C.I. The determination of the dosage-mortalité curve from small numbers. Quart J. Pharm., 1938, 11, 1926.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: gommi arabicum
Doses:
5%

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 420.27 mg/kg bw
Based on:
test mat. (dissolved fraction)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the oral LD50 of the test item is 3420.27 mg/kg in rats