[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated 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: The study was conducted according to valid methods and considered reliable, adequate and relevant.

Principles of method if other than guideline:

Sensitization of guinea pigs was determined by a technique consisting of 8 intracuaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Species:

guinea pig

No. of animals per dose:

20

0 animals were sensitized; 20 animals were tested.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Test material was negative in the guinea pig sensitisation test.

Executive summary:

Epoxidized Soybean Oil (ESBO) was applied in guinea pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3 -week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Weight-of-Evidence for skin sensitisation was obtained from read-across substances. A read-across justification based on molecular, physicochemical and toxicological properties was written as a separate document provided under Section 13 (Assessment reports). The following data were used:

- Epoxidized Soybean Oil (ESBO) was applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.

- 2-Ethylhexyl stearate mono-epoxidized (ESM) was applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial. A 3-week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter. No animals were sensitised of the 20 animals tested.

In conclusion, both studies wiht read-across substances indicate that also for PLSG-5 there is no potential for skin sensitisation after repeated intracutaneous induction followed by challenge.

Migrated from Short description of key information:
Weight-of-Evidence for skin sensitisation was obtained from read-across substances Epoxidized Soybean Oil (ESBO) and 2-Ethylhexyl 9,10-epoxystearate (EMS). Both substances were negative for sensitisation when applied in guinea-pigs by a technique consisting of 8 intracutaneous injections (3 per week on alternate days) of 0.1 mL of the diluted epoxymaterial followed by a 3-week incubation period and challenge. Therefore, 'fatty acids, C16 -18 and C18-unsaturated isopentyl esters, epoxidized' was also considered to have no skin sensitisation potential.

Justification for selection of skin sensitisation endpoint:
Weight-of-Evidence from read-across substances, with similar values.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results and according to the EC criteria for classification and labelling according to CLP regulation (EC No. 1272/2008 of 16 December 2008), 'fatty acids, C16 -18 and C18 -unsaturated isopentyl esters, epoxidized' does not have to be classified and has no obligatory labelling requirement for sensitisation potential.