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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From March 07, 2016 to October 13, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride
EC Number:
942-810-5
Molecular formula:
C43H24ClCuN15O16S6.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 1341.9 < MW < 1374 g/mol (UVCB substance), and traces of NaCl and NaSO4
IUPAC Name:
Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
- Source: WEI XIN HANG
- Weight at study initiation: 301.2-326.6g
- Housing: Every five animals were housed in a stainless steel cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.1 mL and 0.5 mL of 10% CJ303 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
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5 mL of 10% CJ303
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)

Results and discussion

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%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml 10% of CJ303
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml 10% of CJ303
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5ml
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

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

86

325.8

438.2

+112.4

87

301.6

389.6

+88.0

88

326.6

463.4

+136.8

89

302.8

396.0

+93.2

90

301.6

388.4

+86.8

Test group

Male

91

307.2

410.8

+103.6

92

321.2

418.0

+96.8

93

307.8

428.0

+120.2

94

303.4

396.2

+92.8

95

320.6

436.2

+115.6

96

315.4

430.4

+115.0

97

301.8

386.8

+85.0

98

307.0

420.2

+113.2

99

301.2

422.2

+121.0

100

323.4

416.4

+93.0

Table 2. Individual skin reaction of guinea pigs

Group

Sex

Animal ID.

Grade of skin reactiona

Percent of Animals Sensitized

Sensitizing Capacityb

24 ± 1 hrs

48 ± 1 hrs

Control group

Male

86

0

0

0

Weak

87

0

0

88

0

0

89

0

0

90

0

0

Test group

Male

91

0

0

0

Weak

92

0

0

93

0

0

94

0

0

95

0

0

96

0

0

97

0

0

98

0

0

99

0

0

100

0

0

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

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of CJ303 was 0% and CJ303 caused weak sensitization in guinea pigs. Therefore, CJ303 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100145001EN 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 CJ303 show that test reliability criteria was met.

A 10% CJ303 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 10% CJ303. 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 CJ303. Under the conditions of this study, CJ303 did not caused any sensitization in guinea pigs.