Pentyl D-glucoside

Endpoint summary

Description of key information

Oral (WoE, OECD 401, OECD 423), rat: LD50 > 2000 mg/kg bw

Read-across from structural analogue source substances D-Glucopyranose, oligomeric, butyl glycoside (CAS 31387-97-0) and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to analogue justification report provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source, 31387-97-0, Phycher, 2008

Additional studies taken into account in the Weight-of-Evidence approach:

CAS 68515-73-1, Phycher, 2004: LD50 (rat, m/f) > 2000 mg/kg bw

CAS 68515-73-1, Hill Top Research, 1987: LD50 (rat, m/f) > 5000 mg/kg bw

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The LD50 value for acute oral toxicity has been determined to be > 2000 mg/kg bw using adequate analogue source substances.

Executive summary:

The acute oral toxicity of the target substance was estimated based on 3 adequate and reliable in vivo studies of structural analogue source substances accounted for in a Weight-of-Evidence approach. The respective LD50 values for male and female rats as determined in these 3 studies are either > 2000 mg/kg bw or > 5000 mg/kg bw. Therefore, based on read-across, a LD50 value of > 2000 mg/kg bw for the target substance is considered for the hazard assessment and classification & labelling. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate and reliable (Klimisch score 1) studies from source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 (REACH).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The LD50 value for acute toxicity after oral exposure of D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is estimated to be > 2000 mg/kg bw based on reliable studies performed with adequate analogue source substances.

Justification for classification or non-classification

The available data on acute oral toxicity from adequate analogue substances do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are, therefore, conclusive but not sufficient for classification. Based on read-across, D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is also considered not to meet the criteria for classification for acute oral toxicity. According to the provision of Regulation (EC) No. 1907/2006 (REACH), Annex VII, Section 8.5, no data regarding acute toxicity via the inhalation and dermal routes of exposure are required. Hence, no conclusion with respect to these exposure routes can be made.