2,2'-(vinylenedi-p-phenylene)bisbenzoxazole

Endpoint summary

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 for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

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 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 chemical

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".