2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium chloride

Endpoint summary

Description of key information

Skin Irritation:

Signs of irritation were not observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.

Eye Irritation:

Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess the skin irritation potential of Basic Red 12 in rabbits

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report):C.I. Basic Red 12
- IUPAC name: 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride
- Molecular formula: C25H29N2.Cl
- Molecular weight: 392.971 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: >98%
- Impurities (identity and concentrations): <2% (The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.)

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

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:

Scoring system: + = irritant; - = not irritating

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

List of colorants to be classified as toxic

C.I Generic Name	CAS Number	CAS NAME	Active ingredient* in test sample (%)	Irritation**		Symbol	R phrase	S phrase
				Skin [rabbits]	Eye [rabbits]
C.I Basic Red 12 C.I 48070	6320-14-5	3H-Indolium,2-[3-(1,3-dihydro-1,3,3- trimethyl-2H-indol-2-ylidine)-1-propenyl]- 1,3,3-trimethyl-,chloride	>98	-	+	T	25, 41	22 , 26, 44

 

*- The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.

** - Based on test procedures according to OECD guidelines for testing of chemicals: 'Acute oral toxicity' (No. 401), 'Acute dermal irritation/corrosion' (No 404) and 'Acute eye irritation/corrosion' (No. 405)

 

Risk (R) Phrases

23 -toxic by inhalation

24 - toxic in contact with skin

25-toxic if swallowed

33 -danger of cumulative effects

36-irritating to eyes

41-risk of serious damage to eyes

 

Safety(S)phrases

22-do not breathe dust

26-incase of contact with eyes, rinse immediately with plenty of water and seek medical advice

28 - after contact with skin, wash immediately with plenty of soap and water

36 -wear suitable protective clothing

37-wear suitable gloves

44 - if you feel unwell seek medical advice (show the label if possible)

 

+ = irritant;- =non-irritant

Interpretation of results:

other: not irritating

Conclusions:

Since no reactions were observed when Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.

Executive summary:

The dermal irritation potential of Basic Red 12 was assessed in rabbits according to OECD 404 Guidelines.

Basic Red 12 was 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 Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.

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:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

To assess the eye irritation potential of Basic Red 12 in rabbits

GLP compliance:

not specified

Specific details on test material used for the study:

- IUPAC name: 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride
- Molecular formula: C25H29N2.Cl
- Molecular weight: 392.971 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: >98%
- Impurities (identity and concentrations): <2% (The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.)

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

no data available

Observation period (in vivo):

no data available

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

Scoring system: + = irritant; - = not irritating

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: no data available

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

signs of irritation observed

List of colorants to be classified as toxic

C.I Generic Name	CAS Number	CAS NAME	Active ingredient* in test sample (%)	Irritation**		Symbol	R phrase	S phrase
				Skin [rabbits]	Eye [rabbits]
C.I Basic Red 12 C.I 48070	6320-14-5	3H-Indolium,2-[3-(1,3-dihydro-1,3,3- trimethyl-2H-indol-2-ylidine)-1-propenyl]- 1,3,3-trimethyl-,chloride	>98	-	+	T	25, 41	22 , 26, 44

 

*- The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.

** - Based on test procedures according to OECD guidelines for testing of chemicals: 'Acute oral toxicity' (No. 401), 'Acute dermal irritation/corrosion' (No 404) and 'Acute eye irritation/corrosion' (No. 405)

 

Risk (R) Phrases

23 -toxic by inhalation

24 - toxic in contact with skin

25-toxic if swallowed

33 -danger of cumulative effects

36-irritating to eyes

41-risk of serious damage to eyes

 

Safety(S)phrases

22-do not breathe dust

26-incase of contact with eyes, rinse immediately with plenty of water and seek medical advice

28 - after contact with skin, wash immediately with plenty of soap and water

36 -wear suitable protective clothing

37-wear suitable gloves

44 - if you feel unwell seek medical advice (show the label if possible)

 

+ = irritant;- =non-irritant

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.

Executive summary:

The ocular irritation potential of Basic Red 12 was assessed in rabbits according to OECD 405 Guidelines.

Basic Red 12 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 Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

In different studies,1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloridehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across chemicals.

The dermal irritation potential of Basic Red 12 was assessed in rabbits according to OECD 404 Guidelines.

Basic Red 12 was 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 Basic red 12 was applied to rabbit skin, it can be considered to be not irritating to skin.

This is supported by studies 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 target as well read across chemicals, and applying the weight of evidence approach, Basic Red 12 can be considered to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Eye Irritation:

In different studies,1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloridehas been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across chemicals.

The ocular irritation potential of Basic Red 12 was assessed in rabbits according to OECD 405 Guidelines.

Basic Red 12 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 Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.

This is supported by the experimental study performed in albino Vienna White rabbits according to Draize method to assess the ocular irritation potential of the structurally similar read across chemical.

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.

The above studies are further supported by studies performed to determine the ocular irritation potential of the structurally similar read across chemicals. Both the chemicals were 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.

Since signs of irritation were observed when both the chemicals were instilled into rabbit eyes, they can be considered to be irritating to eyes.

Based on the available data for the target as well read across chemicals, and applying the weight of evidence approach, Basic Red 12 can be considered to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Category 2”.

Justification for classification or non-classification

Based on the available studies for Basic Red 12, it is likely to cause irritation to eyes but will not cause any irritation to skin.

Hence, Basic Red 12 can be classified under the category "Category 2" for eye irritation and "Not Classified" for skin irritation as per CLP regulation.