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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
449-410-5
EC Name:
-
Cas Number:
18084-64-5
Molecular formula:
C36H44N4
IUPAC Name:
1,4,7,10-Tetrabenzyl-1,4,7,10-tetraazacyclododecane

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: miglyol 812
Concentration / amount:
intradermal induction (day 1): 5 %
topical induction (day 9): 25%
topical challenge (day 23): 12.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: miglyol 812
Concentration / amount:
intradermal induction (day 1): 5 %
topical induction (day 9): 25%
topical challenge (day 23): 12.5%
No. of animals per dose:
control group: 10 (5/sex)
test substance group: 10 (5/sex)
pre-test (local tolerance test): 10 (4 males and 6 females)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Executive summary:

In a Guinea pig maximization test (GPMT) performed according to OECD TG 406 with 10 animals in control and treament groups each, the test substance, suspended in Miglyol 812, revealed a negative result. Intradermal induction concentration was chosen with 5 % followed by a topical induction concentration of 25 %. Challenge was performed by topical treatment with a 12.5% suspension in Miglyol 812.

Based on this study the test item did not possess a sensitizing effect in Guinea pigs.