Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Remarks:
maternal toxicity rat
Effect level:
>= 2 500 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: no adverse effects observed
Remarks on result:
other: Source CAS 85883-73-4
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOAEL
Remarks:
embryotoxicity/teratogenicity rat
Effect level:
>= 2 500 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects observed
Remarks on result:
other:
Remarks:
Source: CAS 85883-73-4
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

Data from the source substance propylene glycol monocaprylate (CAS 85883-73-4) were selected as key results for reasons of structural similarity and data reliability.

Additional developmental toxicity data were available for the source substance Decanoic acids, mixed diesters with octanoic acid and propylenglycol (CAS 68583-51-7) and Fatty acids, C16-18; ester with ethylenglycol (CAS 91031-31-1). Both substances were tested according to OECD guideline 414 in rats. In both studies the highest tested dose 1000 mg/kg bw/day and 900 mg/kg bw/day were found to be the resulting developmental NOAEL.

Conclusions:
The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their developmental toxicity potential. In three developmental toxicity studies in rats with a) Fatty acids, C6-12, esters with propylene glycol (CAS 85883-73-4), b) Decanoic acid, mixed esters with octanoic acid and propylene glycol (CAS 68583-51-7), and c) Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) no developmental effects were observed. The NOAELS were greater than the highest doses tested (≥900 mg/kg/day). Therefore no developmental toxicity is expected for target substance isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0).

Data source

Materials and methods

Test material

1
Reference substance name:
Isooctadecanoic acid, monoester with propane-1,2-diol
EC Number:
269-027-5
EC Name:
Isooctadecanoic acid, monoester with propane-1,2-diol
Cas Number:
68171-38-0
Molecular formula:
not applicable, substance is UVCB
IUPAC Name:
2-hydroxypropyl 15-methylheptadecanoate

Results and discussion

Applicant's summary and conclusion