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 source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
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 the test material: 2,2'-(Vinylenedi-4-phenylene)bis(benzoxazole)
- IUPAC name: 2,2'-(ethene-1,2-diyldi-4,1-phenylene)bis(1,3-benzoxazole)
- Molecular formula: C28H18N2O2
- Molecular Weight: 414.462 g/mol
- Substance type: Organic
- Smiles: n1c2ccccc2oc1c1ccc(\C=C\c2ccc(c3oc4ccccc4n3)cc2)cc1
- Physical state: Solid
Species:
other: guinea pigs and humans
Strain:
not specified
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil
Day(s)/duration:
single
Adequacy of induction:
other: sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction
Route:
epicutaneous, occlusive
Vehicle:
not specified
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% in water
Day(s)/duration:
3 days
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:
epicutaneous, occlusive
Vehicle:
not specified
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
1. no data available
2. no data available
3. 50
Details on study design:
The study is based on weight of evidence approach from the various test chemicals
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
No reactions 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 skin 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 a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.

Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation.   After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later.   Since there was no evidence of any contact sensitization, the chemical was considered to be not sensitizing on skin of human subjects.

The above results are further supported by another Human repeated insult patch test conducted to assess the skin sensitization potential of chemical.

When the chemical was applied dermally on to the skin of each subject, no evidence of contact sensitization was observed. Hence, the chemical was considered to be not sensitizing on skin of human subjects in a human repeated insult patch test.

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 skin 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 a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.

Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation.   After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later.   Since there was no evidence of any contact sensitization, the chemical was considered to be not sensitizing on skin of human subjects.

The above results are further supported by another Human repeated insult patch test conducted to assess the skin sensitization potential of chemical.

When the chemical was applied dermally on to the skin of each subject, no evidence of contact sensitization was observed. Hence, the chemical was considered to be not sensitizing on skin of human subjects in a human repeated insult patch test.

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".