Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according OECD 422 test substance Isostearic acid, esters with methyl α-D-glucoside (100% UVCB-Substance (80% Methyl Glucoside Isostearate Esters (mainly Di-), 16% Isostearic Acid, 4% Methyl Glucoside (not soluble in Olive Oil)) in 1 % aqueous carboxymethyl cellulose was administered to 10 male and 10 female Wistar Han rats/dose group by daily oral gavage at dose levels of 0, 50, 150, and 1000 mg/kg bw/day. The males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 30 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42 to 44 days). 10 litters per dose group were delivered.

At 1000 mg/kg bw/day statistically significantly reduced haemoglobin, cholesterol and total protein levels (males), and elevated white blood cell counts (determined for only two females) plus alkaline phosphatase levels (males) were found. Increased liver weights (absolute and relative) were noted for high dose males and females.

No treatment-related changes were noted in any of the remaining parameters investigated in this study (i.e. reproduction, breeding, pup development, and of the adults: mortality, clinical appearance, functional observations, body weight, food consumption, macroscopic and microscopic examination,).

The parental NOEL is 150 mg/kgbw/day, based on the findings noted at 1000 mg/kg bw/day

The parental NOAEL is >= 1000 mg/kgbw/day, based on the findings noted at 1000 mg/kg bw/day which were not considered adverse and were without any corroborative findings like histopathological changes. Conduct of the study by the oral route was assessed as the most appropriate pathway as dermal exposure would not lead to significant systemic availability of the test substance due to its very low solubility in aqueous media and inhalative exposure would not be feasible due to the very low volatility of the test substance.

Short description of key information:
Reproductive/Developmental Toxicity
parental NOEL = 150 mg/kgbw/day
parental NOAEL >= 1000 mg/kgbw/day
OECD TG 422, oral exposure

Effects on developmental toxicity

Description of key information
Reproductive/Developmental Toxicity
parental NOEL = 150 mg/kgbw/day
parental NOAEL  >= 1000 mg/kgbw/day
Reproduction, Breeding and Developmental NOAEL >= 1000 mg/kg bw/day
OECD TG 422, oral exposure
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The reproduction, breeding and developmental NOAEL>= 1000mg/kgbw/d.

Justification for classification or non-classification

According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 there is no need for classification of the test substance for reproductive and developmental toxicity.

Additional information