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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Endpoint Assessment Report
Adequacy of study:
key study
Study period:
March 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
other: Endpoint Assessment Report
Title:
Unnamed
Year:
2018
Report date:
2018
Reference Type:
publication
Title:
An evaluation of the safety of PPG-2 myristyl ether propionate.
Author:
Bernard BK, Harris JE, Fischer JE.
Year:
1998
Bibliographic source:
Food Additives & Contaminants. May-Jun;15(4):427-36.

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
An extensive literature search was undertaken to identify studies on the toxicity to repsrotduction of PPG-2 myristyl ether propionate.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)
Molecular formula:
C23H46O4
IUPAC Name:
1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)
Constituent 2
Chemical structure
Reference substance name:
1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)
Molecular formula:
C23H46O4
IUPAC Name:
1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)
Constituent 3
Chemical structure
Reference substance name:
Tetradecyl propionate
EC Number:
228-300-9
EC Name:
Tetradecyl propionate
Cas Number:
6221-95-0
Molecular formula:
C17H34O2
IUPAC Name:
tetradecyl propanoate
Constituent 4
Reference substance name:
PG-2 Tetradecan-1-ol
IUPAC Name:
PG-2 Tetradecan-1-ol
Test material form:
liquid

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Remarks on result:
other: Quantative results not determined

Results: F1 generation

Effect levels (F1)

Key result
Remarks on result:
other: Quantative results not determined

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
Based on the information available it can be concluded that the substance is not toxic to reproduction.
Executive summary:

A reliable study performed by Bernard et al. (1998) was identified in the literature. This study included examination of the reproductive organs of treated animals allowing to investigate the effects of the substance to fertility. No lesions on  reproductive organs were reported. No morphological effects attributable to test substance were observed during the microscopic examination.

It is concluded that PPG-2 myristyl ether propionate is not toxic to reproduction. This is supported by the historical uses of the substance is cosmetics and personal care products.

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