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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: based on expert group reviews
Justification for type of information:
No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data were therefore obtained for the group of propylene glycol stearate (PGS), the relevant hydrolysis products and structural analogues.
PGMS and PGS are both UVCB substances, formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) but PGS has a higher diester content and lower monoester content than PGMS. The UVCB substance belongs to the group of PGS, which are commonly used in cosmetics and as food ingredients (CIR 1983 and CIR 2015).

In order to assess the eye irritation potential of PGMS, the toxicity of PGS in general is therefore considered. Based on the data on PGS, the close similarity between PGS and PGMS and the identical QSAR predictions for the eye irritation potential of PGS and PGMS it can by weight of evidence be concluded that the data is considered acceptable for the present substance.

In general, data from the following expert assessments evaluating PGS are used in a weight of evidence approach:
CIR (1983). Final report on the safety assessment of propylene glycol stearate and propylene glycol stearate self-emulsifying. J Am Coll Toxicol 2(5), 101-124.
CIR (2015). Safety Assessment of Propylene Glycol Esters as Used in Cosmetics. Final amended report December8-9, 2014. 23 pp.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

Principles of method if other than guideline:
The results are based on a weight of evidence analysis from collection of studies extracted from the literature. For more details please refer to the attached weight of evidence document.

Stearic acid, monoester with propane-1,2-diol (PGMS) is an UVCB substance, formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid). The UVCB substance belongs to the group of propylene glycol stearate (PGS), which are commonly used in cosmetics and as food ingredients.

In order to assess the eye irritation potential, the toxicity of PGS in general is therefore considered. PGS is very comparable to PGMS as the substances are formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) although PGS has a higher diester content and lower monoester content than PGMS. As expert-reviewed information/reports on in vivo metabolism and toxicity are available, read-across to data on PGS is considered acceptable for the present substance.

Test material

1
Chemical structure
Reference substance name:
Stearic acid, monoester with propane-1,2-diol
EC Number:
215-354-3
EC Name:
Stearic acid, monoester with propane-1,2-diol
Cas Number:
1323-39-3
Molecular formula:
C21H42O3
IUPAC Name:
2-hydroxypropyl stearate
Test material form:
solid: pellets

Results and discussion

In vivo

Results
Remarks on result:
other: Based on the studies available for propylene glycol stearate, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the test substance is not an eye irritant

Any other information on results incl. tables

The two main constituents of the UVCB substance are both monoester of propane-diol with octadecanoic acid (45-98%) and the monoester of propane-diol with palmitic acid (2-50%). Thus, the UVCB substance belongs to the group of fatty acid esters and has a very similar structure to the well-known monoglycerides – the only exception being the lack of a OH-group on the C3-carbon in the propylene glycol. The UVCB substance is assessed to be metabolised in the same manner as the monoglycerides via the formation of the fatty acid and the propylene glycol.




Three experimental animal eye irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild eye irritation potential of the substance. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not an
eye irritant.



Thus, according to the CLP criteria, EC no 1272/2008, PGMS should not be classified with respect to eye irritation.



Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in
accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data on eye irritation were therefore obtained for the group of propylene glycol stearate (PGS) in the UVCB substance (CIR 1983 and CIR 2015). Results from the three animal studies on eye irritation of PGS were mostly negative results. Therefore, it was concluded that PGS is not an eye irritant. Based on an overall weight of evidence, PGMS should not according to the CLP criteria, EC no 1272/2008 be classified with respect to eye irritation.
Executive summary:

No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data on eye irritation were therefore obtained for the group of propylene glycol stearate (PGS) in the UVCB substance (CIR 1983 and CIR 2015).


 


Three experimental animal eye irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild eye irritation potential of the substance. PGS is very comparable to Stearic acid, monoester with propane-1,2-diol (PGMS) as the substances are formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) although PGS has a higher diester content and lower monoester content than PGMS. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not an eye irritant.


 


Thus, PGMS should not according to the CLP criteria, EC no 1272/2008 be classified with respect to eye irritation.


 


Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.