Registration Dossier

Administrative data

Description of key information

Skin Sensitization:

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatN-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine will also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence based on structurally similar read across chemicals
Justification for type of information:
Weight of evidence based on structurally similar read across chemicals
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence based on structurally similar substances
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
GLP compliance:
not specified
Type of study:
other: Weight of evidence based on structurally similar chemicals
Specific details on test material used for the study:
- Name of the test material: N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Regulatory name: N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine
- Molecular formula: C32H37N5
- Molecular weight: 491.6793 g/mol
- Smiles: CCCCC(CC)CNc1ccc2ccccc2c1/N=N/c3ccc(cc3C)/N=N/c4ccc(cc4)C
- InChI: 1S/C32H37N5/c1-5-7-10-25(6-2)22-33-31-19-15-26-11-8-9-12-29(26)32(31)37-36-30-20-18-28(21-24(30)4)35-34-27-16-13-23(3)14-17-27/h8-9,11-21,25,33H,5-7,10,22H2,1-4H3/b35-34+,37-36+
- Substance type: Organic
Physical form: Dark red clear liquid
Species:
other: humans
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data available
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
no data available
Day(s)/duration:
10 days
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
no data available
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
total - 200
total - 8
Details on study design:
The study is based on weight of evidence approach from the read across values
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
On the basis of available studies for the structurally similar read across substances, the weight of evidence approach is applied to assess the skin sensitization potential for target substance. N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine was estimated to be not sensitizing to skin.
Executive summary:

Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin sensitization potential of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine.

Draize- Shelanski Repeat Insult Patch Test was performed (Joint FAO/WHO Expert Committee on Food Additives, 2004) 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 was 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.

This is supported by the results of the patch test performed (Scientific Committee on Cosmetology (seventh series), 1988) on 8 patients suffering from pigmented contact dermatitis to evaluate the degree of sensitization caused by the test chemical.

1% of the test chemical in petrolatum did not induce any positive reaction in the human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Based on the available data for the structurally similar read across chemicals and applying the weight of

evidence approach, it can be concluded thatN-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-aminewill also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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

Skin Sensitization:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach is applied to assess the skin sensitization potential for target substance. N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine was estimated to be not sensitizing to skin.

Draize- Shelanski Repeat Insult Patch Test was 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 was 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.

This is supported by the results of the patch test performed on 8 patients suffering from pigmented contact dermatitis to evaluate the degree of sensitization caused by the test chemical.

1% of the test chemical in petrolatum did not induce any positive reaction in the human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded thatN-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-aminewill also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies from the structurally similar read across substances indicate a possibility that -(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine can be not sensitizing to skin.

Hence by applying the weight of evidence approach, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.