5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt

Endpoint summary

Description of key information

The substance has no skin sensitising properties

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:

17. March to 17 April 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

84/449/EWG, B.6 (Magnusson-Kligman-Test)

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:

Study was already available

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 267 to 315 g
- Housing: 5/cage
- Diet: Altromin 3112 guinea pig maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17. March to 17 April 1992

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

5% / 0.1 mL per injection

Day(s)/duration:

Day 1

Adequacy of induction:

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

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

25 % / 0.5 mL

Day(s)/duration:

Day 8 for 48 h

Adequacy of induction:

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

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

25% / 0.5 mL

Day(s)/duration:

Day 22 for 24 h

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Determination of primary non-irritating concentration: 6
Determination of the intradermal tolerance: 3
Number of animals in attending group: 5
Number of animals in test group: 10 Number of animals in negative control group: 5

Details on study design:

RANGE FINDING TESTS:
- Determination of primary non-irritating concentration: dermal-occlusive exposure for 24 hours - 3 concentrations (25%, 5%, 1%)
- Determination of the intradermal tolerance: intradermal injection: 2 x 3 concentrations (5%, 1%, 0.2%)

MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 5% TS in 0.9% NaCl, 5% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 8
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 25%

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: TS + water
- Control group: TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

In addition to the control group, 5 further guinea pigs (attending group) were used to confirm that challenge exposure with 25% TS would not lead to dermal irritation in animals pre-treated with 50% FCA.

Positive control substance(s):

yes

Remarks:

bi-annual validation of assay

Positive control results:

valid

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

skin slightly reddish stained by TS

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

skin slightly reddish stained by TS

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Remarks on result:

positive indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

There was no evidence of a positive reaction in animals after challenge treatment with Reactive Red 198 in the present study.
According to the classification criteria of Directive 83/467/EEC, Reactive Red 198 is not sensitizing in the guinea pig maximization test and therefore not subject to labelling requirements.

Executive summary:

Testing for sensitizing properties of Remazol-Rot RB FW getr. was performed in female Guinea pigs according to the method of MAGNUSSON &KLIGMAN.

Intradermal induction was performed using 5% Remazol-Rot RB FW getr. in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Rot RB FW getr. in isotonic saline.

Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.

Based on the results of this study there is no evidence for sensitizing properties of Remazol-Rot RB FW getr.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Sensitisation was assessed using the Magnusson and Kligman sensitisation assay. During the induction phase of the study, no irritation reactions were noted in both control and test groups. Under the conditions of the present study, none of ten animals of the treatment

group showed a positive skin response after the challenge procedure. All sites treated with the test substance were slightly stained by the test item. 

 

On the basis of the results, the substance cannot be considered to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion

Additional information:

The registered chemical is a reactive dye. For this class of dyes it was generally agreed between the members of the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD) that a possible risk for respiratory sensitisation for workers exists at high exposure. However the following should be noted:

 

1) For the substance no history of respiratory problems, such as occupational asthma, is associated with the manufacture and use of the specific substance.

 

2) Due to the granular form of the substance (spay dried in closed system from aqueous solution directly after synthesis) no risk for inhalative exposure arises.

 

The potential to cause respiratory sensitisation is therefore not considered to be applicable for this substance.

No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for sensitisation effects is therefore required.