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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no
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%)
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
Positive control results:
no
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..

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.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation study (Arcelin 1992)

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.


Migrated from Short description of key information:
A FCA test is available on Tricyclododecane dimethanol diacrylate. Based on the results of this test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Only one study is available on Tricyclododecane dimethanol diacrylate to evaluate the skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data

Justification for classification or non-classification

Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer and must be classified as follow :

Regulation EC 1272/2008 : Skin sens.1B

Justification: With an intradermal induction of 5% and 40% of positive reaction : a subcategory "1B" is required.

Directive 67/548/EEC : R43