Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Principles of method if other than guideline:

The sensitization potential of D&C Red 33 was determined by performing patch test on humans.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Species:

human

Sex:

not specified

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

1%

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

1%

No. of animals per dose:

59 patients

Details on study design:

OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.The reactions of the patients were graded as?+. + and ++ categories

Reading:

other:

Hours after challenge:

72

Group:

test chemical

No. with + reactions:

4

Total no. in group:

59

Remarks on result:

other: Reading: other:. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 4.0. Total no. in groups: 59.0.

Interpretation of results:

ambiguous

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The sensitization potential of D&C Red 33 was determined by performing patch tests on humans.59 patients were tested with the dye. 4 patients with ‘?+ ‘results and 2 patients with ‘++ ‘ results were reported.This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.

Executive summary:

The sensitization potential of D&C Red 33 was determined by performing patch tests on humans.

 

The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.

The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories

 

59 patients were tested with the dye.4 patients with ‘?+ ‘ results and 2 patients with ‘++ ‘ results were reported.

 

This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.

 

The CLP classification for the test chemical is ‘Not Classified’

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation:

Applying weight of evidence approach to the available predicted and experimental data for the target as well as read-across chemical, the information is summarised as below

The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .

A sensitization test was carried out in female guinea pigs to estimate the sensitizing potential according to the OECD guideline 406 for Acid Red 33.The maximisation test was performed in female guinea pigs. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulphate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.The study authors concluded that the test substance was not a skin sensitizer.

A skin sensitization test report was published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation, 1988.A sensitization test was carried out in guinea pigs to estimate the sensitizing potential for Acid Red 33A maximimization test in guinea pig was carried out with an induction treatment by intradermal injection of a 5% aqueous solution and by tropical application of 10% aqueous solution. The challenge was made by topical application of 10% and 5% for 2 weeks later. There were no positive reactions. It appeared in this test that 10% in distilled water was not irritating to guinea pig skin. Hence it was considered that the chemical substanceAcid Red 33was not sensitizing to skin after challenge exposure.

A sensitization test of D&C Red 33 was determined by performing patch test on humans was conducted by Guin JD. 2003. The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.

The reactions of the patients were graded as ‘? + ‘, ‘+’ and ‘++’ categories . 59 patients were tested with the dye.4 patients with ‘?+ ‘ results and 2 patients with ‘++ ‘ results were reported.

  This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.

In tests conducted by (R.L. Guest, 1989 and European Commission 2011) with similar substance (CAS: 633-95-5), skin sensitisation test was conducted on female guinea pig .The induction exposure was intradermal, while the challenge exposure was Epicutaneous.After challenge no skin reactions were observed. Therefore, based on the result in this adjuvant test in guinea pigs the test article Acid Orange 7 was considered as a non-sensitizer.

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, in accordance with the CLP criteria. 

Migrated from Short description of key information:
The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .

Justification for selection of skin sensitisation endpoint:
The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

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, in accordance with the CLP criteria.