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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
92/69/EEC, (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A Maximisation test is already available.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
1% w/v
Route:
other: topically
Vehicle:
water
Concentration / amount:
50% w/v; 25% w/v
Challengeopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
1% w/v
Route:
other: topical
Vehicle:
water
Concentration / amount:
50% w/v; 25% w/v
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Concentration / amount
Concentration of test material and vehicle used at induction:
a) Intradermal injection: 1% w/v in sterile water.
b) Topical application: 50% w/v in distilled water.
Concentration of test material and vehicle used for each challenge:
a) Topically: 50% w/v in distilled water.
b) Topically: 25 w/v in distilled water.
Challenge controls:
Concentration / amount
Concentration of test material and vehicle used at induction:
a) Intradermal injection: 1% w/v in sterile water.
b) Topical application: 50% w/v in distilled water.
Concentration of test material and vehicle used for each challenge:
a) Topically: 50% w/v in distilled water.
b) Topically: 25 w/v in distilled water.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% and 25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% and 25%
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

a) Intradermal injection: Slight irritation was seen in test animals.

b) Topical application: No erythema was seen in test animals.

Evidence of sensitisation of each challenge concentration: None

Other observations:

No signs of ill health or toxicity were recorded and all animals showed bodyweight increases over the period of the

study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met