Registration Dossier

Administrative data

Description of key information

Skin Irritation:

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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 structrually similar chemicals
Justification for type of information:
Weight of evidence approach based on structrually 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 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 irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate - Molecular formula: C23H26N3.C2H3O2- Molecular weight: 403.5231g/mole- Smiles : CC(=O)[O-].CC1(C2=CC=CC=C2[N+](=C1C=CC3=CC=C(C=C3)N(C)CCC#N)C)C- Inchl: 1S/C23H26N3.C2H4O2/c1-23(2)20-8-5-6-9-21(20)26(4)22(23)15-12-18-10-13-19(14-11-18)25(3)17-7-16-24;1-2(3)4/h5-6,8-15H,7,17H2,1-4H3;1H3,(H,3,4)/q+1;/p-1- Substance type: Organic- Physical state: Greenish lustrous liquid
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period:
no data available
Number of animals:
no data available
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no signs of irritation observed
Interpretation of results:
other: not irritating
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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate.

 

Studies were performed to determine the dermal irritation potential of the structurally similar read across chemicals. Both the chemicals were applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Since no reactions were observed when both the chemicals were applied to rabbit skin, they can be considered to be not irritating to skin.

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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 ocular irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate - Molecular formula: C23H26N3.C2H3O2- Molecular weight: 403.5231g/mole- Smiles : CC(=O)[O-].CC1(C2=CC=CC=C2[N+](=C1C=CC3=CC=C(C=C3)N(C)CCC#N)C)C- Inchl: 1S/C23H26N3.C2H4O2/c1-23(2)20-8-5-6-9-21(20)26(4)22(23)15-12-18-10-13-19(14-11-18)25(3)17-7-16-24;1-2(3)4/h5-6,8-15H,7,17H2,1-4H3;1H3,(H,3,4)/q+1;/p-1- Substance type: Organic- Physical state: Greenish lustrous liquid
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. 0.1 ml2. no data available
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1. 8 days2. no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1. 32. no data available
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
signs of irritation observed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate.

Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method.

0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from1, 24, 48, 72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize. The Mean score after 8 days was 46.

Based on the score, test chemical was considered to be moderately to severely irritating to eyes.

This is supported by the experimental study performed according to OECD 405 Guidelines to assess the the degree of ocular damage caused by the structurally similar chemical.

The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to eyes.

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate.

 

Studies were performed to determine the dermal irritation potential of the structurally similar read across chemicals. Both the chemicals were applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Since no reactions were observed when both the chemicals were applied to rabbit skin, they can be considered to be not irritating to skin.

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation

Eye Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate.

Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method.

0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from1, 24, 48, 72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize. The Mean score after 8 days was 46.

Based on the score, test chemical was considered to be moderately to severely irritating to eyes.

This is supported by the experimental study performed according to OECD 405 Guidelines to assess the the degree of ocular damage caused by the structurally similar chemical.

The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to eyes.

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

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-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate can be not irritating to skin but causes severe irritation to eyes.

Hence by applying the weight of evidence approach, Reaction mass of 3H-Indolium, 2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]ethenyl]-1,3,3-trimethyl- & acetate can be considered to be not irritating to skin and severely irritating eyes. It can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.