Registration Dossier

Administrative data

Description of key information

Read across to analogue substance (Solvent Red 19E): In vivo skin irritation/corrosion test (EU B.4, GLP compliant) - positive result

 

Read across to analogue substance (Solvent Red 19E): In vivo eye irritation/corrosion test (EU B.5, GLP compliant) - negative result

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:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX
Reason / purpose:
read-across source
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Due to colouration of test substance the evaluation of erythema was not carried out.
Irritant / corrosive response data:
Based on results for an analogue substance, corrosion of the skin is not expected. However the analogue substance did cause dermal tissue changes (observed during histopathological examination). The target substance Solvent Red 19T is therefore also expected to be irritating to the skin.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on read across to an analogue substance, Solvent red 19T is predicted to be irritating to the skin and should be classified as skin irritant Cat 2.
Executive summary:

A read across approach was used to determine skin irritant potential of Solvent Red 19 T ( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine). The results from an analogue substance with the same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group showed some dermal changes and therefore a classification of Skin Irritant Category 2 according to EU CLP criteria. Given the structural similarity, Solvent Red 19T should also be regarded as a skin irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Based on read across to an analogue substance, Solvent Red 19T is not irritating to eyes.
Executive summary:

A read across approach was used to predict eye irritancy of Solvent Red 19T

( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine).

In-vivo data for an analogue subtance, with the

same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group concluded that the substance was not an eye irritant. Solvent Red 19T is therefore predicted to be non irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION:

A read across approach was used to determine skin irritant potential of Solvent Red 19 T ( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine). The results from an analogue substance with the same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group showed some dermal changes and therefore a classification of Skin Irritant Category 2 according to EU CLP criteria. Given the structural similarity, Solvent Red 19T should also be regarded as a skin irritant.

EYE IRRITATION:

A read across approach was used to predict eye irritancy of Solvent Red 19T

( 1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-N-tridecylnaphthalen-2-amine).

In-vivo data for an analogue subtance, with the

same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group concluded that the substance was not an eye irritant. Solvent Red 19T is therefore predicted to be non irritating to eyes.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to eye irritation.

 

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does require classification with respect to skin irritation as Category 2 (H315; Causes skin irritation).