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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/CEE -B7
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-4-chloro-5-formylimidazole
EC Number:
410-260-0
EC Name:
2-butyl-4-chloro-5-formylimidazole
Cas Number:
83857-96-9
Molecular formula:
C8 H11 Cl N2 O
IUPAC Name:
2-butyl-4-chloro-1H-imidazole-5-carbaldehyde

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: solution aqueuse de méthylcellulose à 0,5%
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animalsat 50 mg/kg bW/day
Male: 6 animals at 175 mg/kg bw/day
Male: 6 animals at 600 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female : 6 anima ls at 50 mg/kg bw/day
Female: 6 animals at 175 mglkg bw/day
Female: 6 animals at 600 mg/kg bw/day

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCO unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCO unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Comments :

Les signes observés dans 1es groupes 3 et 4 traduisent une

toxicité hépatique. A 175 mg/ kg/ j , cel1e-ci reste discrète ,

avec des modifications histologiques de type réversibl e (pasde nécrose).

Ceci ne nécessite pas l'étiquetage Xn R48/22 .

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified