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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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