Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol

Endpoint summary

Description of key information

skin sensitisation (OECD 429, mouse): not sensitising

Read-across from isomaltulose (CAS 13718 -94 -0)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue approach justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

test substance at 6.25%

Remarks on result:

other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

test substance at 12.5%

Remarks on result:

other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA

Key result

Parameter:

SI

Value:

0.9

Test group / Remarks:

test substance at 25%

Remarks on result:

other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA

Parameter:

SI

Value:

13.7

Test group / Remarks:

positve control

Interpretation of results:

other: not sensitising according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for read-across

Data on the sensitisation potential of Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol are not available. The assessment of its sensitistaion potential was therefore based on studies conducted with a surrogate substance, isomaltulose (CAS 13718 -94 -0) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Common functional groups and structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin sensitisation

The sensitisation potential of isomaltulose (CAS 13718-94-0) was assessed in a GLP-conducted local lymph node assay according to OECD 429 in female CBA/CaOlaHsD mice (Lütkenhaus, 2013). Given the results of a preliminary test, test animals were exposed to 6.25, 12.5 and 25% (w/v) test item solutions suspended in DMSO. According to OECD 429, the test substance was applied topically to the entire surface of each ear of each mouse once daily for three consecutive days. The proliferative response of lymphocytes in the draining auricular lymph nodes was determined via 3H-methyl thymidine incorporation and the stimulation indices relative to the sham treated controls were calculated. No mortality, clinical signs of toxicity, alterations in body weight or local effects at the application site were observed until the end of the study. Furthermore, no dose-related lymphoproliferative response exceeding the threshold level (SI ≥ 3) was noted for the test substance at the tested concentrations. In detail, the observed stimulation index values were 1.0, 1.0 and 0.9 at test item concentrations of 6.25, 12.5 and 25%, respectively. Thus, isomaltulose did not induce skin sensitisation in the conducted study.

Based on the available data on the sensitising potential of isomaltulose, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol is not considered to exhibit sensitising properties.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on read-across, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.