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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
On request of the Sponsor two additional concentrations were used for challenge.
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study was performed before a justification was required

Test material

Constituent 1
Chemical structure
Reference substance name:
(2E)-1,1,4,4-tetramethoxybut-2-ene; (2Z)-1,1,4,4-tetramethoxybut-2-ene
EC Number:
900-110-7
Cas Number:
5370-08-1
Molecular formula:
C8H16O4
IUPAC Name:
(2E)-1,1,4,4-tetramethoxybut-2-ene; (2Z)-1,1,4,4-tetramethoxybut-2-ene

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF (Himalayan spottet)
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
undiluted and 30%, 10%, 3% in ethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
undiluted and 30%, 10%, 3% in ethanol
No. of animals per dose:
20 females per dose

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: immediately after removing the patch
Hours after challenge:
48
Group:
positive control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Erythema
Remarks on result:
other: Reading: other: immediately after removing the patch. . Hours after challenge: 48.0. Group: positive control. Dose level: only vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Erythema.
Reading:
1st reading
Hours after challenge:
72
Group:
positive control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: positive control. Dose level: only vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
96
Group:
positive control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: positive control. Dose level: only vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
Reading:
other: immediately after removing the patch
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Erythema
Remarks on result:
other: Reading: other: immediately after removing the patch. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Erythema.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
96
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
other: immediately after removing the patch
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: other: immediately after removing the patch. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
96
Group:
test chemical
Dose level:
30
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: 30. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
other: immediately after removing the patch
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: other: immediately after removing the patch. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: -.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not sensitizing
Executive summary:

In this study C4 -Diacetal was administered as 5% ethanolic dilution for intradermal and applied undiluted for epicutaneous induction. Challenging was performed by application of the neat testarticle as well as its 30, 10 and 3% ethanolic dilutions.

Data reported show that after challenging none of the experimental animals elicited skin responses.

Based on this result it can be concluded that C4 -Diacetal possesses no allergenic potential for guinea pigs and may assume that its risk to cause allergic skin responses in man, exposed to this article, is negligible.