Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Endpoint summary

Description of key information

The test substance was not considered to be skin sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From November 12, 1998 to December 04, 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

RA study

Reason / purpose for cross-reference:

read-across: supporting information

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:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A GPMT study was submitted as this was already available before the requirement for LLNA testing was published.

Species:

guinea pig

Strain:

other: Pirbright-White

Sex:

female

Details on test animals and environmental conditions:

From: Harlan Winkelmann
Bodyweight (mean): 368 g
Temperature: 20 +/- 3°C and Relative humidity: 50 +/- 20%
Lighting time: 12 h daily
Food and water: ssniff Ms-H (V2233) and tap water (ad libitum)

Route:

intradermal

Vehicle:

water

Remarks:

deionized

Concentration / amount:

- 50% Freund's Complete Adjuvant emulsion
- 5% test substance (treatment group) or vehicle (control group)
- 50% Freund's Complete Adjuvant emulsion mixed with an equal volume of the test substance treatment group) or vehicle (control group)

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Route:

epicutaneous, occlusive

Vehicle:

water

Remarks:

deionized

Concentration / amount:

25% in 0.5 mL test substance (treatment group) or vehicle (control group)

Day(s)/duration:

48 h

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Remarks:

deionized

Concentration / amount:

5% in 0.5 mL test substance (treatment group) or vehicle (control group)

Day(s)/duration:

24 h

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

- Range finding test:
Determination of the primary non-irritant concentration: 3
Determination of the tolerance of the intradermal injections :2
- Main study
Control group 5
Test substance group 10

Details on study design:

Range finding tests:
Determination of the primary non-irritant concentration
Determination of the tolerance of the intradermal injections
Main study:
A. Induction exposure: the administration area was examined for local tolerance. Any toxic effects were recorded.
B. Challenge exposure: examinations of the skin ca. 24 and 48 h after removal of patches (= 48 and 72 h after start of challenge)
NB. Body weights of the test animals were determined as well

Challenge controls:

left flank

Positive control substance(s):

no

Positive control results:

-

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no effects

Remarks on result:

no indication of skin sensitisation

Observations:

- Determination of the primary non-irritant concentration:

After administration of the 25% test substance concentration discrete or patchy erythema were observed in one animal. No signs of irritation occurred after administration of the 5% and 1% test substance concentration.

- Determination of the tolerance of the intradermal injections:

The intradermal injections with the 5.0% preparation caused slight up to well-defined erythema and oedema. The intradermal injections with the 1.0% preparation caused slight erythema.

The intradermal injections with the 0.2% preparation caused no signs of irritation.

- Intradermal induction:

The intradermal injections with Freund's Adjuvant (with or without test substance) caused severe erythema and edema as well as indurations and encrustations. When the test substance was administered with deionized water, slight erythema and oedema were observed. The vehicle alone did not cause any sign of irritation.

- Dermal induction:

After removal of the patches, severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed at the sites peviously treated with Freund's Adjuvant. The daministration sites treated with the test substance showed slight erythema. The vehicle alone showed no signs of irritation.

- Dermal challenge:

No skin reactions were observed in the control and treatment groups, 24 and 48h after removal of the occlusive bandage.

- The body weight gains of the animals animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not considered to be sensitizing to guinea pig skin.

Executive summary:

A study was conducted to determine the in vivo skin sensitisation potential of the read-across substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. Female Pirbright-White guinea pigs (5 per control group and 10 per test group) were first exposed to the substance intradermally (injections of 50% Freund’s Adjuvant, 5% test substance in deionized water or 5% test substance in 50% Freund’s Adjuvant) and dermally (25.0% test substance in deionized) for 48 h. The dermal challenge consisted of application of an occlusive bandage for 24 h with 5.0% test substance in deionized water. Examinations were conducted 24 and 48 h after removal of the patches. None of the ten treated animals showed a positive skin response after the challenge procedure. Under the study conditions, the substance was not considered to be sensitizing to guinea pig skin (Seeberger, 1999).

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation, in vivo:

A study was conducted to determine the in vivo skin sensitisation potential of the read-across substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. Female Pirbright-White guinea pigs (5 per control group and 10 per test group) were first exposed to the substance intradermally (injections of 50% Freund’s Adjuvant, 5% test substance in deionized water or 5% test substance in 50% Freund’s Adjuvant) and dermally (25.0% test substance in deionized) for 48 h. The dermal challenge consisted of application of an occlusive bandage for 24 h with 5.0% test substance in deionized water. Examinations were conducted 24 and 48 h after removal of the patches. None of the ten treated animals showed a positive skin response after the challenge procedure. Under the study conditions, the substance was not considered to be sensitizing to guinea pig skin (Seeberger, 1999).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of in an vivo skin sensitisation study with the read-across substance, the substance does not warrant classification for skin sensitisation according to EU CLP (EC 1272/2008) criteria.