Registration Dossier

Administrative data

Description of key information

A Freund's Complete Adjuvant 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.


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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1984
Deviations:
no
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
Before the REACH registration, a conclusive and reliable study to evaluate the skin sensitisation potential of the registered substance is available on guinea pigs. No other test is required fot this endpoint.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no
Route:
intradermal
Vehicle:
other: ethanol
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml 5% test item in FCA.
For control: 0.05 ml FCA only.
Day(s)/duration:
Day 1, 5 and 9
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1, 0.3, 1 and 3%
0.025 ml of test item/2cm²
Day(s)/duration:
Day 21 and 35
Adequacy of challenge:
highest non-irritant concentration
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:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
This concentration (3%) is considered to be irritating. Same results observed at 48h and 72h.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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:
positive indication of skin sensitisation

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:
Category 1B (indication of skin sensitising potential) based on GHS criteria
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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer according to the Regulation EC no.1272/208 and must be classified as Skin sens.1B (H317).

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