5-((4-chloro-6-((8-hydroxy-3,6-disulfo-7-((2-sulfo-4-((2(sulfooxy)ethyl)sulfonyl)phenyl)diazenyl)naphthalen-1-yl)amino)-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((Z)-(3-sulfophenyl)diazenyl)naphthalene-2,7-disulfonic acid

Endpoint summary

Description of key information

No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on the available data of the read-across chemicals.

Justification for type of information:

Weight of evidence approach based on the available data of the read-across chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

WoE report is based on Skin sensitization study for read across chemicals.

GLP compliance:

no

Species:

guinea pig

Strain:

other: 2. Dunkin-Hartley 3.Not specified

Sex:

male/female

Details on test animals and environmental conditions:

2. TEST ANIMALS
- Weight at study initiation: weight range of 278 - 342 g,
- Housing: All animals were maintained in galvanized plasticized cages with solid floors
- Diet (e.g. ad libitum): complete pelleted guinea-pig diet supplemented daily with autoclaved hay, ad
libitum
- Water (e.g. ad libitum): tap water, ad libitum
3. Not specified

Route:

epicutaneous, open

Vehicle:

N,N-dimethylformamide

Concentration / amount:

0.1 ml of 10% w/v suspension in 50% aqueous DMF

Day(s)/duration:

48 hrs

Adequacy of induction:

not specified

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

1 ml of 0.05-0.1%

Day(s)/duration:

21 days

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, open

Vehicle:

N,N-dimethylformamide

Concentration / amount:

0.05 ml of 10,1, 0.1% w/v suspension in 50% aqueous DMF

Day(s)/duration:

24 hrs

Adequacy of challenge:

not specified

No.:

#1

Route:

other: Not specified

Vehicle:

not specified

Concentration / amount:

No data available

Day(s)/duration:

Not specified

Adequacy of challenge:

not specified

No. of animals per dose:

2. 10
6 -test group
4- control group

3. Not specified

Details on study design:

2. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: outer surface of the ears
- Frequency of applications: daily for 3 days
- Duration: 24hours
- Concentrations: 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF)
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 6
- Control group: 4
- Site: clipped flanks
- Concentrations: 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF
- Evaluation (hr after challenge): 24 hours after exposure
OTHER: On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst
the pre-treated animals, only erythema in excess of that present in the controls was considered to
denote sensitization; that present in the controls denotes simple primary irritation.

3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 doses
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Frequency of applications: 10 doses in 21 days
- Duration: 21 days
- Concentrations: 1 ml 0.05-0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: Not specified
- Day(s) of challenge: 1
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Concentrations: Not specified
- Evaluation (hr after challenge ): Not specified
OTHER: Challenge was provided 14 days after induction

Challenge controls:

2. no data available
3.Not specified

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10%, 1% and 0.1% w/v suspensions in 50 0/1 aqueous DMF

No. with + reactions:

0

Total no. in group:

6

Clinical observations:

No reactions observed

Remarks on result:

no indication of skin sensitisation

Remarks:

2.

Reading:

1st reading

Group:

test chemical

Dose level:

1 ml 0.05-0.1%

No. with + reactions:

0

Clinical observations:

No skin allergic reactions were observed.

Remarks on result:

no indication of skin sensitisation

Remarks:

3.

Interpretation of results:

other: not sensitizing

Conclusions:

No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal body weight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.

Executive summary:

The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.

In another study, The test chemical was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05-0.1% in isotonic saline , 10 doses  for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The allergic contact sensitization potential of the test chemical was assessed by the ear/flank method in the guinea-pigs. Ten Dunkin-Hartley male and female guinea-pigs were used for this test. On Days 0, 1, and 2 of the test, 0.1ml of 10% w/v suspension in 50% aqueous dimethylformamtde (DMF) was applied to the outer surface of the ears of six animals only. On Day 6, 0.05 ml of 10%, 1% and 0.1% w/v suspensions in 50% aqueous DMF was applied topically to the clipped flanks of all ten animals. On Day 7, any erythema which develops at each site was rated on a 5-point scale. Amongst the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitization; that present in the controls denotes simple primary irritation. No responses were provoked during induction or after challenge exposure by the test chemical. Animals showed normal bodyweight changes and remained in good health throughout the study. Under the conditions of the study, test chemical displayed no strong allergic contact sensitization potential and it can be considered to be not sensitizing to skin.

In another study, The test chemical was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05-0.1% in isotonic saline , 10 doses  for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.