Registration Dossier
Registration Dossier
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EC number: 947-405-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate was estimated to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Weight of evidence approach based on structurally similar chemicals
- Justification for type of information:
- Weight of evidence approach based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on structurally similar chemicals
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal senstiization potential of Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on structurally similar chemicals
- Specific details on test material used for the study:
- - Name of test material: Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate- Molecular formula: C20H24N3OC2H3O2- Molecular weight: 381.473 g/mol- Smiles notation: [N+]=1(c2ccccc2C(C)(C)C1\C=N\NCc1ccc(cc1)OC)C.C(C)(=O)[O-]- InChl: 1S/C20H23N3O.C2H4O2/c1-20(2)17-7-5-6-8-18(17)23(3)19(20)14-22-21-13-15-9-11-16(24-4)12-10-15;1-2(3)4/h5-12,14H,13H2,1-4H3;1H3,(H,3,4)- Substance type: Organic- Physical state: Liquid (Yellow)
- Species:
- other: humans and guinea pigs
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.1
- Day(s)/duration:
- 5
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 24 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 1 days
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1.82. no data available
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate was estimated to be not sensitizing to skin.
- Executive summary:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate
A study was performed in human volunteers to determine the degree of allergic reactions caused by the structurally similar read across chemical.
The test chemical 1% in petrolatum was applied onto the back of 8 healthy patients for 24 hours by using Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days. Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.
No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent sensitizer in human patients suffering from pigmented contact dermatitis.
This is supported by the results of a guinea pig maximization assay performed to determine the allergenic potential of the other structurally similar chemical. During the induction phase, guinea pigs were induced intradermally with injections of 0.1 mL of 0.5% aqueous solution of test chemical on 3 times per day on 5 consecutive days. After a rest period of 4 weeks, animals were challenged with the same concentration and then observed for allergic effects. The treated guinea pigs did not reveal any sensitization potential. Hence, the test chemical was considered to be not sensitizing to the skin of treated guinea pigs.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate was estimated to be not sensitizing to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate.
A study was performed in human volunteers to determine the degree of allergic reactions caused by the structurally similar read across chemical.
The test chemical 1% in petrolatum was applied onto the back of 8 healthy patients for 24 hours by using Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days. Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.
No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent sensitizer in human patients suffering from pigmented contact dermatitis.
This is supported by the results of a guinea pig maximization assay performed to determine the allergenic potential of the other structurally similar chemical. During the induction phase, guinea pigs were induced intradermally with injections of 0.1 mL of 0.5% aqueous solution of test chemical on 3 times per day on 5 consecutive days. After a rest period of 4 weeks, animals were challenged with the same concentration and then observed for allergic effects. The treated guinea pigs did not reveal any sensitization potential. Hence, the test chemical was considered to be not sensitizing to the skin of treated guinea pigs.
Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate was estimated to be not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the structurally similar read across substances indicate a possibility that Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate can be not sensitizing to skin.
Hence by applying the weight of evidence approach, Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- & acetate be considered to be not sensitizing to skin.
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