Registration Dossier
Registration Dossier
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EC number: 260-976-0 | CAS number: 57834-33-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 9, 2016 to January 4, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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
- Reference substance name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- EC Number:
- 260-976-0
- EC Name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Cas Number:
- 57834-33-0
- Molecular formula:
- C17H18N2O2
- IUPAC Name:
- ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Eversorb EP4
- Substance type: Liquid
- Composition of test material, percentage of components: 98.94%
- Lot/batch No.: 4023
- Storage condition of test material: Ambient
Constituent 1
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: 338.9-399.7g
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- 0.1 mL and 0.5 mL of Eversorb EP4 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
- Concentration / amount:
- 0.5 ml of 100% Eversorb EP4
- Day(s)/duration:
- Day 23
- 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:
- 48
- Group:
- positive control
- Dose level:
- 0.5 ml of 100% alpha-Hexylcinnamaldehyde
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5ml of 100% blank control
- 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:
- test chemical
- Dose level:
- 0.5 mL of 100% Eversorb EP4
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
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 |
196 |
339.9 |
416.8 |
+76.9 |
197 |
338.9 |
390.2 |
+51.3 |
||
198 |
380.3 |
459.1 |
+78.8 |
||
199 |
378.6 |
447.2 |
+68.6 |
||
200 |
348.6 |
422.9 |
+74.3 |
||
Test group |
Male |
201 |
375.2 |
444.0 |
+68.8 |
202 |
399.7 |
499.2 |
+99.5 |
||
203 |
341.1 |
427.5 |
+86.4 |
||
204 |
344.2 |
437.3 |
+93.1 |
||
205 |
388.8 |
463.3 |
+74.5 |
||
206 |
395.4 |
493.8 |
+98.4 |
||
207 |
388.9 |
476.5 |
+87.6 |
||
208 |
369.2 |
440.5 |
+71.3 |
||
209 |
357.7 |
437.6 |
+79.9 |
||
210 |
380.2 |
459.8 |
+79.6 |
||
Table 2. Individual skin reaction of guinea pigs
Group |
Sex |
Animal ID. |
Grade of skin reaction1 |
Percent of Animals Sensitized |
Sensitizing Capacity2 |
|
24 ± 1 hrs |
48 ± 1 hrs |
|||||
Control group |
Male |
196 |
0 |
0 |
0% |
Weak |
197 |
0 |
0 |
||||
198 |
0 |
0 |
||||
199 |
0 |
0 |
||||
200 |
0 |
0 |
||||
Test group |
Male |
201 |
0 |
0 |
0% |
Weak |
202 |
0 |
0 |
||||
203 |
0 |
0 |
||||
204 |
0 |
0 |
||||
205 |
0 |
0 |
||||
206 |
0 |
0 |
||||
207 |
0 |
0 |
||||
208 |
0 |
0 |
||||
209 |
0 |
0 |
||||
210 |
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”.
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 Eversorb EP4 was 0% and Eversorb EP4 caused weak sensitization in guinea pigs. Therefore, Eversorb EP4 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100160001EN 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 Eversorb EP4 show that test reliability criteria was met.
A 100% Eversorb EP4 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 100% Eversorb EP4. 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 Eversorb EP4. Under the conditions of this study, Eversorb EP4 did not caused any sensitization in guinea pigs.
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