Registration Dossier

Administrative data

Description of key information

Skin Sensitization:

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence 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 sensitization potential of Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate
GLP compliance:
not specified
Type of study:
other: Weight of evidence based on structurally similar chemicals
Specific details on test material used for the study:
- Name of test material: Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate- Molecular formula: C25H28N2O2- Molecular weight: 388.508 g/mole- Smiles : [N+](=C1/C=CC(\C=C1)=C(\c1ccccc1)c1ccc(cc1)N(C)C)(\C)C.C(C)(=O)[O-]- Inchl: 1S/C23H25N2.C2H4O2/c1-24(2)21-14-10-19(11-15-21)23(18-8-6-5-7-9-18)20-12-16-22(17-13-20)25(3)4;1-2(3)4/h5-17H,1-4H3;1H3,(H,3,4)/q+1;/p-1- Substance type: Organic- Physical state: maroon lustrous liquid
Species:
other: humans
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
2% in water
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
2% in water
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
11
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
Hours after challenge:
24
Group:
test group
Dose level:
2% in water
Total no. in group:
11
Clinical observations:
dermal reactions were observed
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: 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 Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be 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 Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate.

Patch tests were performed to evaluate the degree of allergic reactions caused by various structurally similar read across chemicals.

The patch tests were put on for 20 - 24 hours on the skin of 11 volunteers. They were evaluated for six to seven days. Since the skin got colored by the test chemical, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:

Itching = ±

Isolated papules = +

Edema, confluent papules, infiltration= + +

Vesicular reaction = + + +

Positive reactions to the first structurally similar chemical were observed in all the volunteers. Edema, confluent papules, infiltration were observed in 5 of the 11 volunteers; Vesicular reactions were observed in 2 volunteers.

Positive reactions to the second structurally similar chemical were observed in 8 of the 11 volunteers tested. Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.

Positive reactions to the third structurally chemical were observed in all the volunteers. Edema, confluent papules, infiltration were observed in 5 of the 11 volunteers; Vesicular reactions were observed in 2 volunteers. Based on these reactions, the test chemical was considered to be a potent primary skin sensitizer in humans.

Based on the above reactions and observations, all of the structurally similar chemicals can be considered to be potential skin sensitizers.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be sensitizing to skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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 Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate.

Patch tests were performed to evaluate the degree of allergic reactions caused by various structurally similar read across chemicals.

The patch tests were put on for 20 - 24 hours on the skin of 11 volunteers. They were evaluated for six to seven days. Since the skin got colored by the test chemical, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:

Itching = ±

Isolated papules = +

Edema, confluent papules, infiltration= + +

Vesicular reaction = + + +

Positive reactions to the first structurally similar chemical were observed in all the volunteers. Edema, confluent papules, infiltration were observed in 5 of the 11 volunteers; Vesicular reactions were observed in 2 volunteers.

Positive reactions to the second structurally similar chemical were observed in 8 of the 11 volunteers tested. Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.

Positive reactions to the third structurally chemical were observed in all the volunteers. Edema, confluent papules, infiltration were observed in 5 of the 11 volunteers; Vesicular reactions were observed in 2 volunteers. Based on these reactions, the test chemical was considered to be a potent primary skin sensitizer in humans.

Based on the above reactions and observations, all of the structurally similar chemicals can be considered to be potential skin sensitizers.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate will also tend to behave in a similar manner that of the structurally similar read across substances. Therefore the target chemical was estimated to be 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 Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate can be sensitizing to skin.

Hence by applying the weight of evidence approach, Reaction mass of Methanaminium, N-​[4-​[[4-​(dimethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​methyl-​ & acetate can be considered to be sensitizing to skin.