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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Principles of method if other than guideline:
Annex V
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
EC Number:
415-110-8
EC Name:
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
Cas Number:
54417-53-7
Molecular formula:
C20H25NO4.HCl
IUPAC Name:
(1R)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day

Results and discussion

Results of examinations

Description (incidence and severity):
Increased salivation was detected up to 10 minutes after dosing for animals of either sex treated with 500mg/kg/d from day 4 onwards. No clinical signs were apparent in the decedents prior to death or in animals of either sex treated with 150 or 15 mg/kg/day throughout the study.
Description (incidence and severity):
No adverse effect on bodyweight development, dietary intake, food efficiency or water consumption was detected.
Description (incidence and severity):
Laboratory findings:
Females treated with 500Mg/kg/day showed a reduction in
haemoglobin, haemocrit and erythrocyte count. No such
effects were detected for males treated with 500mg/kg/d or
for animals of either sex at 150 or 15mg/kg/d
Description (incidence and severity):
No treatment related effects were detected in behavioural
assessment tests, sensory reactivity assessments or
functional performance tests.
Description (incidence and severity):
No treatment related macroscopic abnormalities were detected
at terminal kill. The macroscopic abnormalities detected in
teh 500mg/kg/d decedents were all considered to be normal post mortem findings.
Description (incidence and severity):
Histopathological examination revealed treatent related
changes in the thyroid glands. Higher grades of severity of
follicular cell hypertrophy were observed in relation to
treatment for males treated at 500mg/kg/d or at 150mg/kg/d.
No such changes were detected for animals of either sex
treated at 15mg/kg/d.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
clinical biochemistry
clinical signs
gross pathology
haematology
mortality
organ weights and organ / body weight ratios
Dose descriptor:
NOEL
Effect level:
15 mg/kg bw/day (nominal)
Basis for effect level:
clinical biochemistry
clinical signs
gross pathology
haematology
mortality
organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
The substance is not classified for the repeted toxicity.