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Description of key information

Read across to analogue substance: Skin sensitisation in vivo (non-LLNA), Guinea Pigs, Reliable study to GLP standards

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-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 for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
1st reading
Hours after challenge:
24
Group:
other: Naive Control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Naive Control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
1st reading
Hours after challenge:
48
Group:
other: Naive Control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Naive Control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
rechallenge
Hours after challenge:
24
Group:
other: Naive Control
Dose level:
50%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: Naive Control. Dose level: 50%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Reading:
rechallenge
Hours after challenge:
48
Group:
other: Naive Control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: Naive Control. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: No data.
Remarks:
This is the result for the Read across Source Substance Solvent Blue 98
Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Read across to an analogue substance, Solvent blue 98 was used to predict the sensitising potential of Solvent Blue 79B.

The analogue substance Solvent Blue 98 did not induce delayed contact hypersensitivity in guinea pigs. Based on similarity in composition and structure, it is concluded that Solvent Blue 79B is not sensitising.
Executive summary:

A read across approach was used to predict the skin sensitising potential of Solvent Blue 79B ( Reaction mass of Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and1-[(2-ethylhexyl)amino]-4-(3-[(2-ethylhexyl)oxy]propylamino)anthraquinone and 1,4 di (3-[(2-ethylhexyl)oxy]propylamino) anthraquinone

In-vivo (non) LLNA data for an analogue subtance Solvent Blue 98 concluded that the substance did not induce delayed contact hypersensitivity in guinea pigs.  Based on similarity in composition and structure, it is concluded that Solvent Blue 79B is not sensitising.   The analogue substance is compositionally very similar. It is also anthraquinone based, with aliphatic amine substitutions. Where the Solvent Blue 79B contains ethylhexyl amine groups and ethylhexyl)oxy]propylamino groups, the Solvent Blue 98 contains ethylhexyl, methyl and pentyl groups. There is therefore overlap in the compositions and the structures are very similar. Further supporting information on the readacross approach has been provided in section 13 (Read across justification document)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A read across approach was used to predict the skin sensitising potential of Solvent Blue 79B

In-vivo non LLNA data for an analogue substance, with a similar composition, structure and manufacturing process concluded that the substance did not induce sensitisation following dermal exposure.

The analogue substance is NOT classified as a Skin sensistiser and it is concluded that based on the similar structure, Solvent Blue 79B is not a skin sensitiser.

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 not require classification with respect to skin sensitisation. The classification criteria are not met.

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