Registration Dossier

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: NOAEL corresponding to the highest dose tested
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: NOAEL corresponding to the highest dose tested
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