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EC number: 947-399-6 | CAS number: -
Endpoint summary
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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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
- 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 based on structurally similar read across 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & acetate
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence based on structurally similar read across chemicals
- Specific details on test material used for the study:
- - Name of test material: Reaction mass of Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & acetate
- Molecular formula: C29H36N2O2
- Molecular weight: 444.615 g/mole
- Substance type: Organic
- Physical state: maroon lustrous liquid - 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 chemical
- Dose level:
- 2% in water
- Clinical observations:
- signs of dermal reactions 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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 6 of the 9 volunteers.
Edema, confluent papules, infiltration was observed in 2 of 9 volunteers
Positive reactions to the second 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.
Based on the above reactions and observations, both 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitization:
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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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 6 of the 9 volunteers.
Edema, confluent papules, infiltration was observed in 2 of 9 volunteers
Positive reactions to the second 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.
Based on the above reactions and observations, both 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & 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 Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & acetate can be sensitizing to skin.
Hence by applying the weight of evidence approach, Reaction mass of Ethanaminium, N-[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- & acetate can be considered to be sensitizing to skin.
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