Registration Dossier

Administrative data

Description of key information

NOAEL (subchronic, rat) ≥ 1000 mg/kg bw/day, based on read-across

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no studies available on the repeated dose 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 IX, 8.6, 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

Subchronic

No information exists on the repeated dose toxicity of Reaction products of D-Glucose, n-Butanol and alcohols, C10-12 (even numbered), but there is a reliable study available from the structurally related substance D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, which is used for category approach.

The subchronic oral toxicity study with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides was performed in Sprague Dawley CD rats according to EU method B.26 and in conformity with GLP (Henkel, 1989). Aqueous solutions of the test substance were administered daily to groups of 10 male and 10 female rats at doses of 250, 500 and 1000 mg/kg bw/day for 13 weeks via gavage. A similarly constituted group of 10 males and 10 females received water as vehicle and acted as a control. In addition, satellite groups of 5 males and 5 females each for the control and high dose group were used to investigate reversibility of effects in a 27-day post-exposure recovery period. No substance-related mortalities occurred during the study period. Although a slight reduction in the absolute organ weights of gonads, brain and thymus as well as slight increases in the relative organ weights of adrenal gland and liver occurred, these effects were not considered to be treatment-related since no corresponding changes in histopathology were observed. Due to bolus administration and the irritating potential of the test substance, inflammation and ulcerations of the mucous membrane of the forestomach were observed.

Based on the results of the subchronic study with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, the systemic NOAEL for rats was considered to be 1000 mg/kg bw/day. Due to the strong structural relationship with this category member, no toxicity is expected to occur after repeated exposure to Reaction products of D-Glucose, n-Butanol and alcohols, C10-12 (even numbered).


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Hazard assessment is conducted by means of read-across based on a category approach. 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 selection of repeated dose toxicity inhalation - systemic effects endpoint:
No study required since 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.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
No study required since 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.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
No study required since data from structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, article 1.5 demonstrate a lack of acute toxicity via the dermal route and negligible dermal absorption through human skin in vitro.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
No study required since data from structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, article 1.5 demonstrate a lack of acute toxicity via the dermal route and negligible dermal absorption through human skin in vitro.

Justification for classification or non-classification

The available data on the repeated dose toxicity via the oral route of a substance structurally related to Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols according to the criteria laid down in 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, Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols does not meet the criteria for classification, either, and the data are thus conclusive but not sufficient for classification.