Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Endpoint summary

Description of key information

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.

In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: as mentioned data

Principles of method if other than guideline:

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of test chemical

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Species:

other: Human

Strain:

other: Not specified

Sex:

not specified

Details on test animals and environmental conditions:

Not specified

Route:

epicutaneous, occlusive

Vehicle:

water

Day(s)/duration:

24 hours application for 10 alternate days

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

200 subjects

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period:24 hours
- Test groups: 200 subjects
- Control group: no data
- Site: volvar forearms
- Frequency of applications:
- Duration: 10 alternate days
- Concentrations: no data

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days
- Exposure period: 24 hours
- Test groups: 200 subjects
- Control group:
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): after 24 hours

Challenge controls:

Not specified

Positive control substance(s):

not specified

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

No data available

No. with + reactions:

0

Total no. in group:

200

Clinical observations:

None of the subjects showed any signs of contact sensitization.

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: Not sensitizing

Conclusions:

The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.
 
Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

Executive summary:

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.

 

In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

 

Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies have been reviewed to ascertain the potential of the test chemical to cause dermal sensitization in living organisms. These include in vivo experimental studies performed on guinea pigs as well as humans for the test chemical. The results are summarized as follows:

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.

In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

This is supported by the results of a Patch test conducted to evaluate the dermal sensitization potential of the test chemical. 20% test chemical in water was applied in Finn Chambers to the skin of 15 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories 16 patients were tested with the dye. None of the patients showed any signs of sensitization. Thus the test chemical can be considered as non sensitizer to human skin.

The above results are further supported by the Draize- Shelanski Repeat Insult Patch Test performed on 200 human subjects to determine the degree of dermal sensitization caused by the test chemical.

The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.

Hence, the test chemical was considered to be not sensitizing to skin.

Based on the available in vivo results, the test chemical indeed lacks the potential to cause sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations to the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available in vivo results, the test chemical indeed lacks the potential to cause sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations to the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.