Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate

Endpoint summary

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:

1987/1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

no

Type of study:

guinea pig maximisation test

Species:

guinea pig

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: ICI Colours and FIne Chemical
- Weight at study initiation: 250-396 g

Route:

intradermal

Vehicle:

water

Concentration / amount:

treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water

No. of animals per dose:

20

Challenge controls:

1% (w/v) preparation of the Reactive Blue 198 in deionised water to the left shorn flank

Positive control substance(s):

no

Positive control results:

Challenge with a 46% (w/v) preparation of the test sample in deionised water elicited a strong sensitisation response in previously-induced guinea pigs. Challenge with a 26% (w/v) preparation of the test sample in deionised water elicited a moderate sensitisation response in previously-induced guinea pigs. No sensitisation response was elicited following challenge with a 1% (w/v) preparation of the test sample in deionised water.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

26% (w/v) preparation of the test sample in deionised water

No. with + reactions:

5

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 5.0. Total no. in groups: 20.0.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

26% (w/v) preparation of the test sample in deionised water

No. with + reactions:

10

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 10.0. Total no. in groups: 20.0.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The present study has shown that after the release treatment 50% of the animals has given positive response.
According to the evaluation criteria of Directive 83/467/EEC, Reactive Blue 198 in the maximization test is a moderate sensitizer.

Executive summary:

The net response was calculated to be 67% and, therefore, when previously induced guinea pigs were challenged with a 46% (w/v) preparation of Reactive Blue 198, a strong sensitisation response was elicited. Following challenge with a 26% (w/v) preparation of the test sample in deionised water, moderate diffuse redness was observed in three test animals and scattered mild redness in seven test animals. None of the control animals showed a response.

The net response was calculated to be 50% and, therefore, when previously induced guinea pigs were challenged with a 26% (w/v) preparation of Reactive Blue 198, a moderate sensitisation response was elicited.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The net response was calculated to be 67% and, therefore, when previously induced guinea pigs were challenged with a 46% (w/v) preparation of Reactive Blue 198, a strong sensitisation response was elicited. Following challenge with a 26% (w/v) preparation of the test sample in deionised water, moderate diffuse redness was observed in three test animals and scattered mild redness in seven test animals. None of the control animals showed a response.

The net response was calculated to be 50% and, therefore, when previously induced guinea pigs were challenged with a 26% (w/v) preparation of Reactive Blue 198, a moderate sensitisation response was elicited.

Justification for selection of skin sensitisation endpoint:
According to the evaluation criteria of Directive 83/467/EEC, Reactive Blue 198 in the maximization test is a moderate sensitizer.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available