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REACH

7-({[3-({4-[(2-hydroxy-1-naphthyl)diazenyl]phenyl}diazenyl)phenyl]sulfonyl}amino)naphthalene-1,3-disulfonic acid, lithium sodium salts

EC number: 943-074-8 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

The sensitization rate of CJ321 was 0% and CJ321 caused weak sensitization in guinea pigs (OECD TG406).

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:

From December 23, 2016 to March 30, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

- Source: National Laboratory Animal Center, Taipei, Taiwan
- Age: approximately 5 to 6 weeks
- Weight at study initiation: 314-407 g
- Housing: Every two animals were housed in a stainless steel wire mesh cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light

Route:

intradermal and epicutaneous

Vehicle:

water

Remarks:

Water for injection

Concentration / amount:

0.1 mL 1 % and 0.4 mL 20% of CJ321 for intradermal and epicutaneous, respectively

Day(s)/duration:

Day0 and Day7 for intradermal and epicutaneous, respectively

Adequacy of induction:

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

Route:

epicutaneous, occlusive

Vehicle:

water

Remarks:

Water of injection (WFI)

Concentration / amount:

0.2 mL 10 % of CJ321

Day(s)/duration:

Day21

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

For control group: Five
For treated group: Ten

Positive control substance(s):

yes

Remarks:

α-Hexylcinnamaldehyde (HCA)

Positive control results:

The latest results showed that positive control animals had shown maximum skin reactions of 2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 60%.

Reading:

1st reading

Hours after challenge:

Group:

test chemical

Dose level:

10 % of CJ321

No. with + reactions:

Total no. in group:

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

Group:

negative control

Dose level:

Water for injection

No. with + reactions:

Total no. in group:

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

Group:

positive control

Dose level:

5% HCA

No. with + reactions:

Total no. in group:

Remarks on result:

positive indication of skin sensitisation

Group #1: Control group

Group #2: Treated group

Table 1. Individual Body Weight and Clinical Observations

Animal#	Group #	Body Weight (g)		Observation
Animal#	Group #	Day 0	Day 24	D0-24
01	1	377	449	Normal
02	1	407	484	Normal
03	1	361	405	Normal
04	1	387	447	Normal
05	1	370	443	Normal
06	2	407	508	Normal
07	2	383	463	Normal
08	2	391	517	Normal
09	2	374	419	Normal
10	2	340	443	Normal
11	2	314	441	Normal
12	2	345	454	Normal
13	2	326	409	Normal
14	2	396	501	Normal
15	2	390	497	Normal

Table 2. Individual Skin Reaction on Induction Sites

Animal#	Group #	Site	Maximum score (Erythema / Edema)
			Study Day
			3	7	10	14	17	21	24
01	1	ID_1	2 / 1	3 / 2	4 / 2	4 / 3	4 / 3	4 / 3	4 / 3
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	0 / 1	3 / 2	4 / 2	4 / 3	4 / 3	4 / 3	4 / 3
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
02	1	ID_1	0 / 1	3 / 2	4 / 2	4 / 3	4 / 3	4 / 3	4 / 3
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	0 / 1	3 / 2	4 / 2	4 / 3	4 / 3	4 / 3	4 / 3
		Topical	-	-	2 / 2	2 / 3	2 / 2	2 / 2	2 / 2
03	1	ID_1	1 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	1 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
04	1	ID_1	2 / 1	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	0 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
05	1	ID_1	0 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	0 / 1	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
06	2	ID_1	1 / 1	3 / 3	4 / 2	4 / 3	4 / 4	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 2	4 / 3	4 / 4	4 / 1	4 / 1
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 1	2 / 2
07	2	ID_1	2 / 1	3 / 3	4 / 2	4 / 3	4 / 4	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 2	4 / 3	4 / 3	4 / 2	4 / 1
		Topical	-	-	2 / 2	2 / 2	2 / 3	2 / 2	2 / 2
08	2	ID_1	0 / 1	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		ID_2	1 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 3	4 / 3	4 / 3	4 / 1	4 / 1
		Topical	-	-	2 / 3	2 / 2	2 / 2	2 / 2	2 / 2
09	2	ID_1	0 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 2	4 / 2
		ID_2	1 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 3	4 / 3	4 / 4	4 / 1	4 / 1
		Topical	-	-	2 / 2	2 / 2	2 / 3	2 / 2	2 / 3
10	2	ID_1	1 / 1	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 3	2 / 2	2 / 3
11	2	ID_1	0 / 1	3 / 2	4 / 2	4 / 3	4 / 4	4 / 3	4 / 3
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	2 / 2	3 / 2	4 / 2	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
12	2	ID_1	0 / 1	3 / 2	4 / 2	4 / 3	4 / 4	4 / 3	4 / 3
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 2	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2
13	2	ID_1	0 / 1	3 / 2	4 / 2	4 / 3	4 / 3	4 / 3	4 / 3
		ID_2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 2	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 3	2 / 2	2 / 2
14	2	ID_1	0 / 1	3 / 2	4 / 3	4 / 3	4 / 4	4 / 3	4 / 3
		ID_2	0 / 0	3 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 3	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 3	2 / 2	2 / 3	2 / 2	2 / 2
15	2	ID_1	0 / 1	3 / 2	4 / 3	4 / 3	4 / 3	4 / 3	4 / 3
		ID_2	0 / 0	3 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
		ID_3	3 / 2	3 / 2	4 / 3	4 / 3	4 / 3	4 / 2	4 / 2
		Topical	-	-	2 / 2	2 / 2	2 / 2	2 / 2	2 / 2

Table 3. Individual Sensitization Observation

Animal#	Group #	Score
Animal#	Group #	24h	48h
01	1	1	1
02	1	1	1
03	1	1	1
04	1	2	1
05	1	0	1
06	2	1	1
07	2	1	1
08	2	0	0
09	2	1	1
10	2	1	1
11	2	1	1
12	2	0	1
13	2	1	0
14	2	1	0
15	2	1	1

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 406 test method and “Magnusson and Kligman Maximization Grading”, the sensitization rate of CJ321 was 0% and CJ321 caused weak sensitization in guinea pigs. Therefore, CJ321 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316013-IR which is based on the SOP for the OECD 406 (CTPS-TE00516) and OECD 406 (OECD, 1992). The results of this OECD 406 test for CJ321 show that test reliability criteria was met.

A 1% and 20% CJ321 was used for intradermal injection and occlusively patched, respectively, to ten test guinea pigs to induce sensitization.The water for injection was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 10% CJ321. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 0% treated animals showed sensitization to the CJ321. Under the conditions of this study, CJ321 caused weak sensitization in guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

All animals appeared clinically normal throughout the study. The body weights of all animals increased at the end of study.

During the study period, the erythema or edema were observed at three pairs of intradermal injection sites in all animals. This was caused by test article and the expected reaction caused by FCA treatment. After topical induction, the erythema or edema with scores 1 to 3 were also observed at application sites in all animals.

The sensitivity and reliability of GPMT method were assessed by using a positive control, alpha-Hexylcinnamaldehyde (HCA; CAS No. 101-86-0) at Testing Facility. The latest results showed that positive control animals had shown maximum skin reactions of 2 and the sensitization rate of HCA was 60% (Appendix IX). Therefore, the results met the acceptance criteria (a response of at least 30%) and the GPMT method of Testing Facility is a valid method in compliance with OECD #406.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:: no study available

Justification for classification or non-classification

The skin sensitization rate of CJ321 was 0% and CJ321 caused weak sensitization in guinea pigs (OECD TG406).

However, the result has not met a category based on GHS criteria.

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