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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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:
developmental toxicity / 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 Fatty acids, C6-12, esters with propylene glycol (CAS 85883-73-4) was selected as key results for reasons of structural similarity and data reliability.

Additional data from a developmental toxicity study is given for the source substance Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7. No adverse toxic effects were seen in this study at doses up to 1000 mg/kg bw/day. The NOAEL for maternal and developmental/teratogenicity was found to be≥1000 mg/kg bw/day in male and female rats.

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 a developmental toxicity oral gavage study (OECD 414) in rats with the analogue substance Fatty acids, C6-12, esters with propylene glycol (CAS 85883-73-4) the NOAEL for developmental toxicity/teratogenicity and maternal toxicity was found to be greater than 2500 mg/kg/day (highest dose tested).
In a developmental toxicity oral gavage study (OECD 414) in rats with the analogue substance Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) the NOAEL for developmental toxicity/teratogenicity and maternal toxicity was found to be greater than 1000 mg/kg/day (highest dose tested).
Therefore, no hazard with regard to developmental toxicity / teratogenicity is expected for the target substance Propylene dinonanoate (41395-83-9).

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylene dinonanoate
EC Number:
255-350-9
EC Name:
Propylene dinonanoate
Cas Number:
41395-83-9
Molecular formula:
C21H40O4
IUPAC Name:
propylene dinonanoate

Results and discussion

Applicant's summary and conclusion