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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Principles of method if other than guideline:
The predicton is done using Danish (Q)SAR Database
GLP compliance:
no
Type of study:
other: Allergic contact dermatitis (ACD) in guinea pig and human
Species:
other: guinea pig and human
Strain:
not specified
Sex:
not specified
Route:
other: no data
Vehicle:
no data
Route:
other: no data
Vehicle:
no data
Reading:
other: estimation
Group:
test group
No. with + reactions:
0
Clinical observations:
not sensitising
Remarks on result:
other: Reading: other: estimation. Group: test group. No with. + reactions: 0.0. Clinical observations: not sensitising.

other details not known

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for the chemical. Thus it can be concluded that the substance has no skin sensitization effects and based on the CLP criteria for classification it can be classified as negative to skin sensitization effects.
Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for the chemical. Thus it can be concluded that the substance has no skin sensitization effects and based on the CLP criteria for classification it can be classified as negative to skin sensitization effects.

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

Skin Sensitization

The skin sensitisation potential of Pyrazolone T is estimated using OECD QSAR toolbox version 3.3 The test item Pyrazolone T was not sensitizing to skin of CBA mice in Mouse local Lymph node Assay (LLNA) assay.

Based on the QSAR prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for the chemical. Thus it can be concluded that the substance has no skin sensitization effects and based on the CLP criteria for classification it can be classified as negative to skin sensitization effects.

In other study by (JOE DINARDO .et al.2007) with similar substance (1934-21-0) was assayed in guinea pig. Modified Buehler and the Klecak method for open epicutaneous testing (OET) test was conducted in guinea pig to study the skin sensitisation of chemical tartrazine. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, The challenge phase began after a two-week Rest period Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. All test sites were graded.. Hence, Non-sensitising effects were known in skin sensitisation test of chemical tartrazine tested in guinea pigs by Buehler and the Klecak method for open epicutaneous testing (OET).

In other study by (SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS 2004) with similar substance (1934-21-0) was assayed in human. Human patch test was conducted was conducted to study the skin sensitisation of chemical Acid yellow 23.32 patients (20 women, 12 men) with a positive patch test reaction to p aminoazobenzene were tested with dose concentration of 2%.Patch tests were performed using uniform patch tests, Acid Yellow 23 did not elicit an allergic reaction .Hence, Non-sensitising effects were known skin sensitisation test of chemical tartrazine in Human patch test.

In other study by (SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS 2004) with similar substance (1934-21-0) was assayed in guinea pig. A 5 % Acid Yellow 23 solution was applied in an emulsion of Freund´s Complete Adjuvant (FCA) for the intradermal induction. 1 week later, following treatment with sodium lauryl sulfate (SLS) the epidermal induction was conducted for 48 h under occlusion with a 50 % Acid Yellow 23 solution. 2 wk later the animals were challenged by epidermal application of Acid Yellow 23 (25 % solution) under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. For challenge reading, all animals were depilated 3 h before examination to remove the discolouration. None of the control and test animals showed skin reactions after the challenge treatment with Acid Yellow 23. The 50 % test item stained the skin orange, therefore it was not possible to determine whether erythema were present or not. However, no oedema was observed. Hence, Non-sensitising effects were known skin sensitisation test of chemical tartrazine Maximisation (Magnusson and Kligman) Test.

In other study by (Mary Ann Liebert, 1992) with similar substance (89-25-8) was assayed in guinea pig. The skin sensitization test was carried out in 20 albino guinea pigs (10 males and 10 females) to determine the sensitization potential of test substance Edaravone (CAS No: 89-25-8)by using patch test.In the induction phase, the test material was applied at concentration of 0.5% in water (50mL) to the clipped skin of the left scapular region using an occlusive patch for 1 hour and the skin was rinsed with water. The test site was evaluated 1, 6, 24, and 48 h after rinsing. This procedure was repeated, three times per week with a minimum 2 day interval between doses, for a total of 10 applications following the non treatment period of 12days, the animals were challenged and 0.5 ml of test chemical was applied to the clipped skin on the left flank of the abdomen using an occlusive patch. The patch was removed 1 h after dosing and the test site was rinsed. The test site was observed 1, 6, 24, and 48 h after rinsing It was observed that the animals did not exhibit sensitization response at challenge concentrations therefore the test material Edaravone (CAS No:89-25-8) was found to be non sensitizing to the albino guinea pigs.

On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin.


Migrated from Short description of key information:
The skin sensitisation potential of Pyrazolone T is estimated using OECD QSAR toolbox version 3.3
The test item Pyrazolone T was not sensitizing to skin of CBA mice in Mouse local Lymphnode Assay (LLNA) assay.

Justification for selection of skin sensitisation endpoint:
The skin sensitisation potential of Pyrazolone T is estimated using OECD QSAR toolbox version 3.3
The test item Pyrazolone T was not sensitizing to skin of CBA mice in Mouse local Lymphnode Assay (LLNA) assay.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance Pyrazolone T was classified as non- sensitizing.