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Reaction products of 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts
EC number: 948-044-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 06, 2017 to April 03, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The guinea pig Buehler test is already available for the registration outside of EU. Therefore, LLNA is not conducted.
Test material
- Reference substance name:
- Reaction products of 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts
- EC Number:
- 948-044-8
- Molecular formula:
- C10H5N3O6S.C10H9NO4S.C2H4O2.1/3Cr.Co.H2O4S.7H2O.C3Cl3N3.C8H11NO6S2.xNa
- IUPAC Name:
- Reaction products of 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Laboratorio Nacional Agropecuana Lanagro S.P.
- Age at study initiation: 12-15 weeks old
- Housing: ten animals per sex were grouped inside polypropylene cages
- Acclimation period: at least 5 days
- Temperature (°C): 18.0-23.0 °C
- Humidity (%): 48-70 %
- Photoperiod: 12-hrs dark / 12-hrs light
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- Day(s)/duration:
- Days 0-14
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 14-28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Two for pilot study, twenty for treatment group and ten for control group
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- The result of α-Hexylcinnamaldehyde (HCA) was 50% of the animals showed positive response of sensitivity.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- 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:
- negative control
- Dose level:
- 100%
- 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:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1. Skin Reactions Observed in the Pilot Study.
Concentration Agreed (%) |
Weight (g) |
Animals # |
Sex |
Skin Reaction |
||
Initial |
Final |
After 24 hours |
After 48 hours |
|||
100 |
503 |
512 |
1 |
♀ |
0 |
0 |
75 |
497 |
509 |
2 |
♀ |
0 |
0 |
Table 2. Skin Reactions Observed in Test Group at Inductions Period.
Animal # |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
|
Sex |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
|
Initial weight (g) |
480 |
560 |
548 |
566 |
646 |
502 |
584 |
558 |
494 |
536 |
427 |
550 |
474 |
591 |
603 |
463 |
563 |
569 |
558 |
527 |
|
1st Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2nd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3rd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 3. Skin Reactions Observed in Control Group at Inductions Period.
Animal # |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
31 |
32 |
|
Sex |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
♀ |
|
Initial weight (g) |
550 |
479 |
573 |
507 |
517 |
510 |
585 |
550 |
508 |
517 |
|
1st Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2nd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3rd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 4. Skin Reactions Observed in Test Group at Challenge Period.
Animal # |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
Final weight (g) |
690 |
595 |
697 |
642 |
671 |
533 |
628 |
582 |
713 |
586 |
626 |
644 |
677 |
605 |
600 |
595 |
692 |
612 |
690 |
631 |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 5. Skin Reactions Observed in Control Group at Challenge Period.
Animal # |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
31 |
32 |
Final weight (g) |
707 |
696 |
670 |
561 |
681 |
505 |
637 |
636 |
550 |
612 |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 6. Clinical and Behavioral Alterations Observed in the Animals of Test Group.
Group |
Test |
||||||||||||||||||||||
Animal # |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
|
Pilot |
24hrs |
0 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
48hrs |
0 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
1st Induction |
24hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2nd Induction |
24hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3rd Induction |
24hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Challenge |
24hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 7. Clinical and Behavioral Alterations Observed in the Animals of Control Group.
Group |
Control |
||||||||||
Animal # |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
31 |
32 |
|
1st Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2nd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3rd Induction |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Challenge |
24hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0: None visual alterations observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 406 test method, Everzol SR98 showed that non-sensitizing to guinea pigs. Therefore, Everzol SR98 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the BIOAGRI Study Plan for 16264.467.103.17.The results of this OECD 406 test for Everzol SR98 show that test reliability criteria was met. The concentration agreed as 100% was applied in the inductions and in the challenge, according to the results obtained in the pilot study and inductions periods. The quantity of 0.5 mL of the test item homogenized in purified water was held in contact with the skin of the flank region for a 6-hours exposure period. Thirty-two (females nulliparous and non-pregnant) guinea pigs were tested, two for pilot study, twenty for treatment group and ten for control group, maintained under controlled environmental conditions during the acclimation and observation periods. Each one of the twenty treatment animals was exposed to the test item in both inductions and challenge, although all ten control animals were exposed to the test item only during the challenge period. Skin reactions after inductions and after challenge period were appraised according to the Magnusson & Kligman’s grading scale. Reactions were evaluated 24 and 48 hours after occlusive bandages removes, approximately. When applied on the guinea pigs’ skin, the test item did not cause any alteration in challenge period. Therefore, Everzol SR98 was classified as non-sensitizing to guinea pigs.
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