Registration Dossier
Registration Dossier
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EC number: 265-390-9 | CAS number: 65087-00-5
Endpoint summary
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
- 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 for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- 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 chemical
- 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".
Reference
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".
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