3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Maximization tests

GLP compliance:

not specified

Type of study:

other: Maximization tests

Species:

human

Strain:

not specified

Sex:

not specified

Route:

other: no data

Vehicle:

petrolatum

Concentration / amount:

20% (13,800 lg/cm2) tricyclodecenyl acetate and 8% (5520 micro.gm./cm2) tricyclodecenyl acetate

Route:

other: occlusion

Vehicle:

petrolatum

Concentration / amount:

20% (13,800 lg/cm2) tricyclodecenyl acetate and 8% (5520 micro.gm./cm2) tricyclodecenyl acetate

No. of animals per dose:

26 volunteers and 21 volunteers

Details on study design:

Test material was applied in petrolatum under occlusion to the forearms for a total of five alternate-day 48-h periods. Each application was preceded by a 24-h occlusive treatment of the patch sites with 5% aqueous sodium lauryl sulfate (SLS). Following a 10- to 14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 h.Challenge applications were preceded by 30 min applications of 2–5% SLS under occlusion on the left side and no pretreatment on the right side.

Challenge controls:

Following a 10- to 14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded
by 30 min applications of 2–5% SLS under occlusion on the left side and no pretreatment on the right side. Challenge sites were evaluated at removal of the patches and 24 h later.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20

No. with + reactions:

0

Total no. in group:

26

Clinical observations:

There was no evidence of contact sensitization

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20. No with. + reactions: 0.0. Total no. in groups: 26.0. Clinical observations: There was no evidence of contact sensitization.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

8

No. with + reactions:

0

Total no. in group:

21

Clinical observations:

There was no evidence of contact sensitization

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 8. No with. + reactions: 0.0. Total no. in groups: 21.0. Clinical observations: There was no evidence of contact sensitization.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In two separate maximization tests involving 26 and 21 volunteers, there was no evidence of contact sensitization to 20% (13,800 lg/cm2)or 8% (5520 lg/cm2) tricyclodecenyl acetate(3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate), respectively.

Executive summary:

In two separate maximization tests involving 26 and 21 volunteers, there was no evidence of contact sensitization to 20% (13,800 lg/cm2)or 8% (5520 lg/cm2) tricyclodecenyl acetate(3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate), respectively.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
In two separate maximization tests involving 26 and 21 volunteers, there was no evidence of contact sensitization to 20% (13,800 lg/cm2)or 8% (5520 lg/cm2) tricyclodecenyl acetate(3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate), respectively.

Justification for classification or non-classification

3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate will not be classified as per the C & L criteria set by EU.