Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
EC Number:
427-090-8
EC Name:
A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
Cas Number:
116044-44-1
IUPAC Name:
bis(ethyl (2R,3R)-3-(propan-2-yl)bicyclo[2.2.1]hept-5-ene-2-carboxylate)

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 150 and 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 150 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Biochemical and histopathological effects seen at top dose (1000 mg/kg)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on histopathological changes seen in the liver and biochemical changes at the top dose, a no effect level of 150mg/kg has been established in the rat.