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 irritation (OECD 439): not irritating

Eye irritation (OECD 437): not irritating

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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

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

Irritation / corrosion parameter:

% tissue viability

Remarks:

mean value of 3 tissues

Run / experiment:

15 min

Value:

95

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Source: CAS 13718-94-0, Lehmeier, 2012, EpiSkin

Interpretation of results:

other: non-irritant according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified
Under the conditions of the reconstructed human epidermis test the test item does not possess iritant properties. Applying the read-across approach, similar results are expected for the target substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

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

Adequacy of study:

key study

Study period:

30 Oct 2012

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Number of animals or in vitro replicates:

3 corneas each for the test item, negative and positive controls

Irritation parameter:

in vitro irritation score

Value:

0.75

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Source: CAS 13718-94-0, Luetkenhaus, 2013, BCOP

Interpretation of results:

other: non-irritant to the eye according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified
Under the conditions of the Bovine Corneal Opacity and Permeability (BCOP) Test the test item does not possess eye iritant properties. Applying the read-across approach, similar results are expected for the target substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for read-across

There are no experimental data available regarding skin and eye irritation/corrosion for Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol. Thus, read-across from an appropriate surrogate substance (isomaltulose, CAS 13718-94-0) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII and VIII, 8.1. Common functional groups and structural similarities 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 irritation in vitro

The skin irritation potential of isomaltulose (CAS 13718-94-0) was determined in a GLP-compliant in vitro skin irritation test according to OECD 439 on EpiSkinTM human skin equivalents (SkinEthic laboratories, Lyon, France) after moistening (Lehmeier, 2012). After exposure to 10 mg isomaltulose and a post-incubation period of 42 h, cytotoxicity measurements revealed a relative mean tissue viability of 95% compared to the respective controls. In contrast, application of the positive control substance SDS (5%) reduced the relative tissue cell viability to 7% of the control tissues thereby validating the study. In accordance with the classification criteria given in OECD guideline 439 and Regulation (EC) No 1272/2008, isomalutlose is considered as non-irritant.

Furthermore, no signs of skin irritation were noted in a Local Lymph Node Assay conducted with isomaltulose. Thus, together with the available data on in vitro skin irritation, there is sufficient weight of evidence available leading to the conclusion that isomaltulose and hence isomalt is not irritating to skin.

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

Eye irritation in vitro

The eye irritation/corrosion potential of isomaltulose (CAS 13718-94-0) was tested in a GLP-compliant in vitro bovine corneal opacity and permeability test according to OECD 437 (Lütkenhaus, 2013). 750 µL of the test item solution, 20% dissolved in 0.9% NaCl, were introduced into the anterior chamber of the corneal holders for 4 h. Subsequent measurements after rinsing revealed a mean opacity value of 1.33 and a mean permeability value of 0.028 resulting in an in vitro irritancy score (IVIS) of 0.75. According to the evaluation criteria given in OECD 437, the conducted in vitro test did not identify isomaltulose as an ocular irritant.

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

Justification for classification or non-classification

Based on read-across, the available data on skin or eye irritation are conclusive but not sufficient for classification

according to Regulation (EC) No. 1272/2008.