Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1992-01-16 to 1992-02-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generaaly accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: ethanol
Concentration / amount:
Induction (day 1, 5 and 9): intradermal injections of 0.1 ml 5% test item in FCA. For control: 0.05 ml FCA only.
Challenge (day 21 and 35): epicutaneous, 0.025 ml of test item/2cm² (0.1, 0.3, 1 and 3%)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Induction (day 1, 5 and 9): intradermal injections of 0.1 ml 5% test item in FCA. For control: 0.05 ml FCA only.
Challenge (day 21 and 35): epicutaneous, 0.025 ml of test item/2cm² (0.1, 0.3, 1 and 3%)
No. of animals per dose:
5
Details on study design:
0.1 ml of a 5% dilution of the test article in vehicle mixed with the same volume of Freund's Complete Adjuvant were injected intradermally into the guinea pig flanks on days 1, 5 and 9. The experimental animals and controls (pretreated with 0.05 ml of FCA only) were tested epicutaneously on day 22. This challenge test was performed by applying 0.025 ml of each test concentration to skin areas of 2 cm². Skin reactions were read 24, 48 and 72 hours after application of the test material.
Challenge controls:
no
Positive control substance(s):
no

Results and discussion

Positive control results:
no

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 - 0.3 - 1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Same results were observed at 48h and 72h.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 - 0.3 - 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Same results were observed at 48h and 72h..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
Same results were observed at 48h and 72h. This concentration (3%) is considered to be irritating.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Same results were observed at 48h and 72h. This concentration (3%) is considered to be irritating..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
5
Clinical observations:
Same results were observed at 48h and 72h.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: Same results were observed at 48h and 72h..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.3%
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
Same results were observed at 48h and 72h.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3%. No with. + reactions: 4.0. Total no. in groups: 5.0. Clinical observations: Same results were observed at 48h and 72h..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% and 3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
Same results were observed at 48h and 72h.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% and 3%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: Same results were observed at 48h and 72h..

Any other information on results incl. tables

The highest non-irritating concentration applied at the pre-treatment was 1%.

The test article is considered as being allergenic when 1 out of 5 animals of the experimental group shows positive reactions to primary non-irritating concentration used for challenge.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer in guinea pigs.
Executive summary:

In this skin sensitisation test, 0.1 ml of a 5% dilution of the test article in vehicle mixed with the same volume of Freund's Complete Adjuvant were injected intradermally into the guinea pig flanks on days 1, 5 and 9. The experimental animals and controls (pretreated with 0.05 ml of FCA only) were tested epicutaneously on day 22. This challenge test was performed by applying 0.025 ml of each test concentration to skin areas of 2 cm². Skin reactions were read 24, 48 and 72 hours after application of the test material.

The highest non-irritating concentration applied at the pre-treatment was 1%.

The test article is considered as being allergenic when 1 out of 5 animals of the experimental group shows positive reactions to primary non-irritating concentration used for challenge. According to the findings observed it must be considered that the test substance showed positive allergenic reactions at the primary highest non-irritating concentration of 1% (5/5, 100%) and at the non-irritating concentrations of 0.3% (4/5, 80%) and 0.1% (2/5, 40%) diluted in ethanol. The effects observed at the 3% concentration level must be considered as acute irritation, because in a pre-test the highest non-irritating concentration was found to be 1% of test item diluted in ethanol.

Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer in guinea pigs.