D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides

Endpoint summary

Description of key information

Oral (OECD 401), rat (m/f): LD50 > 2000 mg/kg bw (limit test)
Dermal (OECD 402), rabbit (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2) and one disregarded study (Klimisch score 4).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2) and one disregarded study (Klimisch score 4).

Additional information

There is only limited data available on the acute dermal toxicity of D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides. In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted following a category approach.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

Oral

Two acute oral toxicity studies in rats are available for D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides (CAS 157707-87-4). In the key study, 5 male and 5 female Sprague Dawley rats were exposed to a limit dose of 2000 mg/kg bw according to OECD guideline 401 (Drug Safety Testing Center, 1988). No mortality and no adverse effects were observed up to the end of the 14-day observation period. Based on the results of the study, the oral LD50 value for male and female rats was greater than 2000 mg/kg bw.

In another study, which was performed equivalent or similar to OECD guideline 401, treatment with the test substance at limit dose resulted in a LD50 greater than 2000 mg/kg bw in male and female rats, and thus supports the findings of the key study (Zeneca, 1993).

Dermal

There is only limited data available on the acute dermal toxicity of D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides (CAS 157707-87-4). An insufficiently documented study in male and female rats revealed no signs of systemic toxicity at a dose of 2000 mg/kg bw (ICI Central, 1993).

However, two reliable studies for the category members D-Glucopyranose, oligomeric, C10-16-alkyl glycosides and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) exist, which were used for read-across based on the category approach. Both studies were performed according to OECD guideline 402 and in compliance with GLP.

In the acute dermal toxicity study with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, the test substance was applied at a limit dose of 2000 mg/kg bw on the skin of 5 male and 5 female New Zealand White rabbits for 24 h. Clinical signs of partly hunched posture and slight depression occurred during the observation period. No mortality and no adverse effects including those on the skin were observed during the study period. Therefore, the dermal LD50 value of the test substance for male and female rabbits was greater than 2000 mg/kg bw (Hill Top Biolabs, 1989).

In a similar study performed with the category member D-Glucopyranose, oligomers, decyl octyl glycosides, no substance-related mortalities were observed after dermal application of the test substance at a limit dose of 2000 mg/kg bw in male and female New Zealand White rabbits. Test substance-related clinical changes of emaciation (2/5), nasal discharge (3/5), faecal stains (5/5), yellow area throughout the site of application (5/5) and lacrimation (1/5) occurred in the animals. Irritative effects on the skin in the form of moderate to marked erythema, mild to moderate edema, atopy, desquamation, and mild coriaceousness were most frequently observed within the animals. Based on the result of this study, the dermal LD50 value of the test substance for male and female rabbits was greater than 2000 mg/kg bw (Hill Top Biolabs, 1987).

Inhalation

This information is not available. The substance has a low vapour pressure and is marketed in aqueous formulation; therefore, human exposure to vapours or dusts is not to be expected. In addition, reliable data from studies with the substance itself for acute toxicity via the oral and dermal route and from studies performed with structurally related substances according to Regulation (EC) No. 1907/2006, Annex XI, article 1.5 via the dermal route are available.

Justification for selection of acute toxicity – oral endpoint
The selected study is the most adequate and reliable study based on overall quality assessment.

Justification for selection of acute toxicity – inhalation endpoint
No study required since the substance has a low vapour pressure and is marketed in liquid form; therefore, human exposure to vapours or dusts is not to be expected.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the most adequate and reliable study based on overall quality assessment.

Justification for classification or non-classification

The available data on the acute toxicity of D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides and structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC; therefore, D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides is not expected to exert acute toxicity, either, and the data are thus conclusive but not sufficient for classification.