Registration Dossier

Administrative data

Description of key information

Oral (OECD 401), rat (m/f): LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat (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:
5 000 mg/kg bw
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) and consistent studies.

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 adequate, reliable (Klimisch score 2 due to read-across) studies from reference substances with similar structure and intrinsic properties.

Additional information

There is only limited data available on the acute toxicity of Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols. 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

One acute oral toxicity study in rats is available for Decyl glucoside. In this key study, 5 male and 5 female Wistar rats were exposed to a limit dose of 5000 mg/kg bw according to OECD guideline 401 (BASF, 1982). No mortality occurred during the study. Clinical signs in form of dyspnoea, rattle, apathy, diarrhoea, spastic gait, shaggy fur, stagger, exsiccosis and poor general condition were observed in males and females. These effects only remained a few hours or days and were reversible up to the end of the 14-day observation period. Based on these results, the oral LD50 value for rats was greater than 5000 mg/kg bw.

A further study on the acute oral toxicity study in rats according to OECD guideline 423 and in compliance with GLP is available for the structurally related category member butyl D-glucoside (CAS 31387-97-0), which is one of the constituents of the substance to be registered (Phycher Bio-Développement, 2008) (for details see category justification). No mortality and no adverse effects were observed up to the end of the 14-day observation period. Based on the results, the oral LD50 value for female rats was greater than 2000 mg/kg bw. In accordance with OECD guideline 423, the oral LD50 cut-off of the test substance may be considered to be higher than 5000 mg/kg bw.

Dermal

No data are available on the acute dermal toxicity of the Reaction products of D-Glucose, n-Butanol and alcohols, C10-12 (even numbered), but 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 (for details see category justification). 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 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, either. 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, as well (Hill Top Biolabs, 1987).

Inhalation

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

Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across based on a category approach (for details see category justification). The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on the acute toxicity of Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols 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, and are therefore conclusive but not sufficient for classification.