(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate

Endpoint summary

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.