Registration Dossier

Administrative data

Description of key information

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.

Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

 

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:
data from handbook or collection of data
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Specific details on test material used for the study:
- Name of test material: 2,4-bis[(E)-2-(4-dodecylphenyl)diazen-1-yl]benzene-1,3-diol
- Common name: 2,4-bis[(4-dodecylphenyl)azo]resorcinol
- Molecular formula: C42H62N4O2
- Molecular weight: 654.978 g/mol
- Smiles notation: c1(c(c(c(cc1)\N=N\c1ccc(cc1)CCCCCCCCCCCC)O)\N=N\c1ccc(cc1)CCCCCCCCCCCC)O
- InChl: 1S/C42H62N4O2/c1-3-5-7-9-11-13-15-17-19-21-23-35-25-29-37(30-26-35)43-45-39-33-34-40(47)41(42(39)48)46-44-38-31-27-36(28-32-38)24-22-20-18-16-14-12-10-8-6-4-2/h25-34,47-48H,3-24H2,1-2H3/b45-43+,46-44+
- Substance type: Organic
- Physical state: Solid
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Route:
intradermal
Vehicle:
other: saline (1:1) in olive oil
Concentration / amount:
3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g of 1.0% test chemicals
Day(s)/duration:
48 h
Adequacy of induction:
not specified
Route:
other: no data available
Vehicle:
not specified
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1ml of 0.05-0.1% solution in isotonic saline
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
0.03 ml of test material in acetone
Day(s)/duration:
72 hours
Adequacy of challenge:
not specified
No.:
#1
Route:
other: no data available
Vehicle:
not specified
Adequacy of challenge:
not specified
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1ml of 0.05-0.1% solution in isotonic saline
Adequacy of challenge:
not specified
No. of animals per dose:
no data available
Details on study design:
Weight of evidence approach based on various test chemicals
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
no signs of dermal sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Executive summary:

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Magnusson & Kligman guinea pig maximization test (GPMT) was conducted on six Female Hartley strain albino guinea pigs to assess the dermal sensitization potential of the test chemical.

Induction treatment consisted of 3 intra-dermal injections and one topical induction. On day 0, a row of 3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil was given on each side of the 2x4 cm clipped neck. In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test chemicals in petrolatum were occlusively applied for 48 h. The samples were covered with lint pads which were lining with Blenderm tape.

The challenge treatment was given by open topical application. On day 21, the flank regions of the animals were clipped and shaved, and then 0.03 ml of test material in acetone was applied to the skin for 72 hrs. Observations were made 48 hrs after challenge. No positive reaction was elicited at the concentrations tested.

Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin.

This result is supported by the skin sensitization test of test chemical carried out in guinea pigs to determine its sensitization efficacy.

Since the guinea pigs did not elicit any sensitizing effect, the test chemical considered to be not sensitizing to the guinea pigs.

The above results are further supported by the skin sensitization study performed in guinea pigs to assess the sensitization potential of the test chemical.

During the induction phase, Guinea pigs were subcutaneously given 10 doses of 1ml of 0.05-0.1% solution in isotonic saline (duration of exposure, number of animals not specified).A challenge test was also conducted after 14 days of induction.

No dermal reactions were observed in guinea pigs during the induction and challenge exposure. Hence, the test chemical can be considered to be not sensitizing to guinea pig skin.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

 

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

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Magnusson & Kligman guinea pig maximization test (GPMT) was conducted on six Female Hartley strain albino guinea pigs to assess the dermal sensitization potential of the test chemical.

Induction treatment consisted of 3 intra-dermal injections and one topical induction. On day 0, a row of 3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil was given on each side of the 2x4 cm clipped neck. In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test chemicals in petrolatum were occlusively applied for 48 h. The samples were covered with lint pads which were lining with Blenderm tape.

The challenge treatment was given by open topical application. On day 21, the flank regions of the animals were clipped and shaved, and then 0.03 ml of test material in acetone was applied to the skin for 72 hrs. Observations were made 48 hrs after challenge. No positive reaction was elicited at the concentrations tested.

Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin.

This result is supported by the skin sensitization test of test chemical carried out in guinea pigs to determine its sensitization efficacy.

Since the guinea pigs did not elicit any sensitizing effect, the test chemical considered to be not sensitizing to the guinea pigs.

The above results are further supported by the skin sensitization study performed in guinea pigs to assess the sensitization potential of the test chemical.

During the induction phase, Guinea pigs were subcutaneously given 10 doses of 1ml of 0.05-0.1% solution in isotonic saline (duration of exposure, number of animals not specified).A challenge test was also conducted after 14 days of induction.

No dermal reactions were observed in guinea pigs during the induction and challenge exposure. Hence, the test chemical can be considered to be not sensitizing to guinea pig skin.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with 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

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.

Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".