Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)

Endpoint summary

Description of key information

The sensitization rate of Everlan SL65 was 0% and Everlan SL65 did not caused any skin 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:

Jan 20, 2016 - Dec 07, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

OECD 406:1992

Deviations:

no

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:

male

Details on test animals and environmental conditions:

- Source: WEI XIN HANG
- Weight at study initiation: 332.5-449.5g
- Housing: Every five animals were housed in a stainless steel wire mesh cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Concentration / amount:

0.1mlLand 0.5mL 4% of Everlan SL65 for intradermal and epicutaneous, respectively

Day(s)/duration:

Day1 and Day7 for intradermal and epicutaneous, respectively

Adequacy of induction:

non-irritant substance, but skin pre-treated with 10% SDS

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

0.5 mL 4% of Everlan SL65

Day(s)/duration:

Day23

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

For control group: five
For test group: ten

Positive control substance(s):

yes

Remarks:

α-Hexylcinnamaldehyde (HCA)

Positive control results:

The latest results showed that positive control animals had shown skin reactions of 1-2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 100%.

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

4%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

4%

No. with + reactions:

5

Total no. in group:

5

Table 1. The body weight of the guinea pigs

Group	Sex	Animal ID.	Animal Weight (g)		Weight Change (g)
			Day 1	Day 26
Control group	Male	11	417.9	506.4	+ 88.5
		12	449.5	538.8	+ 89.3
		13	389.3	492.8	+ 103.5
		14	332.5	433.2	+ 100.7
		15	448.6	545.2	+ 96.6
Test group	Male	16	406.8	504.0	+ 97.2
		17	428.6	517.8	+ 89.2
		18	426.8	515.6	+ 88.8
		19	346.9	444.2	+ 97.3
		20	389.6	475.2	+ 85.6
		21	395.6	488.6	+ 93.0
		22	368.5	458.6	+ 90.1
		23	428.6	512.0	+ 83.4
		24	435.4	520.0	+ 84.6
		25	348.9	436.4	+ 87.5

Table 2. Individual skin reaction of guinea pigs

Group	Sex	Animal ID.	Grade of skin reaction^1		Percent of Animals Sensitized	Sensitizing Capacity^2
			24 ± 1 hrs	48 ± 1 hrs
Control group	Male	11	0	0	0%	Weak
		12	0	0
		13	0	0
		14	0	0
		15	0	0
Test group	Male	16	0	0	0%	Weak
		17	0	0
		18	0	0
		19	0	0
		20	0	0
		21	0	0
		22	0	0
		23	0	0
		24	0	0
		25	0	0

¹ The skin reaction was grading according to “Magnusson and Kligman scale”.

² The sensitizing capacity of the test article was classified according to the “Scoring system of Kligman”.

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of Everlan SL65 was 0% and Everlan SL65 caused no notable sensitisation potential in guinea pigs. Therefore, Everlan SL65 did not meet a category for classification based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100103002EN which is based on the SOP for the OECD 406 (SOPP-339) and OECD 406 (OECD, 1992). The results of this OECD 406 test for Everlan SL65 show that test reliability criteria was met.

A 4% Everlan SL65 was used for intradermal injection and occlusively patched to ten test guinea pigs to induce sensitization.The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 4% Everlan SL65. 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 Everlan SL65. Under the conditions of this study, Everlan SL65 did not caused any sensitization in guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A 4% Everlan SL65 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization. The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 4% Everlan SL65. 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 Everlan SL65. Under the conditions of this study, Everlan SL65 did not caused any sensitization in guinea pigs.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available