Registration Dossier

Administrative data

Description of key information

Read across to analogue substance:

Local Lymph Node Assay (LLNA): sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
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
Key result
Parameter:
SI
Value:
8.35
Test group / Remarks:
50%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Remarks:
The test substance at the highest dose level caused a dose dependent increase in radioisotope incorporation into the DNA of dividing lymphocytes.
Key result
Parameter:
SI
Value:
3.27
Test group / Remarks:
5%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Remarks:
The test substance at the highest dose level caused a dose dependent increase in ra dioisotope incorporation into the DNA of dividing lymphocytes
Key result
Parameter:
SI
Value:
1.64
Test group / Remarks:
0.5%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Remarks:
0.5% is below the threshold
Parameter:
other: DPM
Value:
943.17
Test group / Remarks:
50%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Parameter:
other: DPM
Value:
369.29
Test group / Remarks:
5%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Parameter:
other: DPM
Value:
184.83
Test group / Remarks:
0.5%
Remarks on result:
other: This is the result for the Read across Source Substance Solvent Red 19E
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on a read across approach to an analogue subtance, Solvent Red 19T is predicted to elicit a sensitising response in a LLNA assay and therefore should be classified as Skin sensitiser Cat 1B according to EU CLP criteria.
Executive summary:

A read across approach was used to predict the skin sensitising potential of Solvent Red 19T

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

In-vivo LLNA 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 caused a dose dependent increase in radioisotip incoration into the DNA of dividing lymphocytes. The analogue substance is classified as Skin sensistiser Cat 1B, and it is concluded that based on the similar structure, Solvent Red 19T should also be classified as Skin sensitiser Cat 1B.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A read across approach was used to predict the skin sensitising potential of Solvent Red 19T

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

In-vivo LLNA data for an analogue substance, with the

same structure, but where the tridecyl group has been replaced with a 2 -ethyl hexyl group concluded that the substance caused a dose dependent increase in radioisotip incoration into the DNA of dividing lymphocytes. The analogue substance is classified as Skin sensistiser Cat 1B, and it is concluded that based on the similar structure, Solvent Red 19T should also be classified as Skin sensitiser Cat 1B.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 require classification with respect to skin sensitisation,Category 1B (H317; May cause an allergic skin reaction).