Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Oral acute toxicity tests were performed on four members of this category (covering C12-C22 alkyl polyglucosides) according to OECD 401 guideline.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The category of C12-22 alkyl polyglucoside is built with substances of Unknown or Variable composition, Complex reaction product or Biological material (UVCB substances). The substances in this particular category are consisting of fatty alcohols (even numbered) with mono and di-glucosides, called alkylpolyglucosides. Each category member is manufactured from fatty alcohol and glucose. All the members of this category are either mixture of fatty alcohols reacted with glucose or blends of alkyl glucosides of various chain lengths and degrees of polymerization.

The alcohols of substances included in this category are saturated linear compounds with a chain length from 12 to 22 carbons (even numbered), and the alkylpolyglucosides are formed of a hydrophobic carbon chain, with the same length, linked to one or two glucoses. The polymerization rate is close to 1 (1.2 to 1.5).

 

The starting material 12-hydroxystearic alcohol is composed of saturated linear alcohols with a chain length of 18 carbons and thus falls into the category.

 

Oral acute toxicity tests were performed on four members of this category (covering C12-C22 alkyl polyglucosides) according to OECD 401 guideline. All these members display a LD50 > 2000 mg/kg bw per day.

Dermal acute toxicity tests were performed on three members of the category covering C14 -C22 alkylpolyglucosides according to OECD 402. All these members display a LD50 > 2000mg/kg bw per day.

Considering the close similarity with regards to APG C12 hydroxy, one assumed that this compound was part of the category, which represented the whole range of alkyl polyglucosides compiled in this group.

 

Therefore, this category of C12-22 alkyl polyglucoside including “acetalization product between glucose and 12-hydroxystearyl alcohol” is concluded as getting a LD50 (oral) > 2000 mg/kg bw per day and a LD50 (dermal) > 2000 mg/kg bw per day.

Justification for classification or non-classification

As a result of the read-across approach based on grouping of the seven substances in a category, the LD50 (oral) and the LD50 (dermal) of the substance are concluded to be > 2000 mg/kg bw per day which results in no classification for both routes of exposure.