Registration Dossier
Registration Dossier
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EC number: 700-680-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
In oral and dermal acute toxicity studies a LD50 value for Isostearic acid, esters with methyl α-D-glucoside could not be derived up to and including the limit dose of 2000 mg/kg bw.
Isostearic acid, esters with methyl α-D-glucoside has been tested up to and including the limit dose for repeated dose toxicity testing stipulated in Guideline B.7/B.8/B.26. of Council Regulation (EC) No 440/2008 laying down the test methods pursuant to Regulation (EC) No 1907/2006 (REACH). Since up to and including the limit dose of 1000 mg/kg bw/d, the animals were free of any critical substance related effects, it can be assumed that Isostearic acid, esters with methyl α-D-glucoside has no intrinsic hazardous toxic activity relevant to humans by single or repeated oral exposure. Because of this proven absence of intrinsic hazardous activity, Isostearic acid, esters with methyl α-D-glucoside poses no risk relevant to humans by repeated oral exposure and a calculation of a corresponding Derived No Effect Level (DNEL) is not appropriate as no NOAEL based on toxic effects could be determined in adequately conducted studies.
In the oral repeated dose toxicity study the NOAEL is >= 1000 mg/kg bw/day for male and female rats. A point of departure for the assessment of systemic toxicity after oral exposure could not be derived due to the lack of substance related critical health effects up to and including the limit dose of the study design.
Dermal repeat-dose studies are not available. The derivation of a Worker-DNEL long-term dermal is not indicated due to the lack of an appropriate point of departure (NOAEL >= 1000 mg/kg bw/d). As an actual value for the NOAEL could not be determined due to limit dose testing in this study type, it could be much higher than 1000 mg/kg bw/day. The dermal resorption and consequent systemic availability of the test substance is considered to be very low due to its relatively high molecular weight of 726 (average) and its very low solubility in aqueous media (< 0.5 mg/L).
Likewise, inhalation studies are not available. As Isostearic acid, esters with methyl α-D-glucoside has a very low vapour pressure (< 1.47 x 10-3 Pa) and due to its waxy consistence formation of vapours or inhalable aerosols, particles or droplets at the working place and for the general population can be excluded. Therefore, a DNEL for inhalative exposure appears not warranted.
This is further stressed by the fact that an equivalent Worker-DNEL long-term inhalation is not appropriate for the working place were short term peak concentrations would be the focus.
A DNEL for fertility and developmental toxicity has not been derived because no substance related effects have been detected up to and including the limit dose in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to the OECD test guideline 422.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
In oral and dermal acute toxicity studies a LD50 value for Isostearic acid, esters with methyl α-D-glucoside could not be derived up to and including the limit dose of 2000 mg/kg bw.
Isostearic acid, esters with methyl α-D-glucoside has been tested up to and including the limit dose for repeated dose toxicity testing stipulated in Guideline B.7/B.8/B.26. of Council Regulation (EC) No 440/2008 laying down the test methods pursuant to Regulation (EC) No 1907/2006 (REACH). Since up to and including the limit dose of 1000 mg/kg bw/d, the animals were free of any critical substance related effects, it can be assumed that Isostearic acid, esters with methyl α-D-glucoside has no intrinsic hazardous toxic activity relevant to humans by single or repeated oral exposure. Because of this proven absence of intrinsic hazardous activity, Isostearic acid, esters with methyl α-D-glucoside poses no risk relevant to humans by repeated oral exposure and a calculation of a corresponding Derived No Effect Level (DNEL) is not appropriate as no NOAEL based on toxic effects could be determined in adequately conducted studies.
In the oral repeated dose toxicity study the NOAEL is >= 1000 mg/kg bw/day for male and female rats. A point of departure for the assessment of systemic toxicity after oral exposure could not be derived due to the lack of substance related critical health effects up to and including the limit dose of the study design.
Dermal repeat-dose studies are not available. The derivation of a Worker-DNEL long-term dermal is not indicated due to the lack of an appropriate point of departure (NOAEL >= 1000 mg/kg bw/d). As an actual value for the NOAEL could not be determined due to limit dose testing in this study type, it could be much higher than 1000 mg/kg bw/day. The dermal resorption and consequent systemic availability of the test substance is considered to be very low due to its relatively high molecular weight of 726 (average) and its very low solubility in aqueous media (< 0.5 mg/L).
Likewise, inhalation studies are not available. As Isostearic acid, esters with methyl α-D-glucoside has a very low vapour pressure (< 1.47 x 10-3 Pa) and due to its waxy consistence formation of vapours or inhalable aerosols, particles or droplets at the working place and for the general population can be excluded. Therefore, a DNEL for inhalative exposure appears not warranted.
A DNEL for fertility and developmental toxicity has not been derived because no substance related effects have been detected up to and including the limit dose in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to the OECD test guideline 422.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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