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Diss Factsheets

Administrative data

Description of key information

Glyceryl isostearate and glyceryl laurate were evaluated in the maximization test and both showed slight signs of irritation, but no sensitization (Anderson 2004). A maximization test with ethylene glycol is negative (Karihara 1996).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Remarks:
no details provided
Principles of method if other than guideline:
Full title: Final Report of the Amended Safety Assessment of Glyceryl Laurate, Glyceryl Laurate SE, Glyceryl Laurate/Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Glyceryl Cocoate, Glyceryl Collagenate, Glyceryl Erucate, Glyceryl Hydrogenated Rosinate, Glyceryl Hydrogenated Soyate, Glyceryl Hydroxystearate, Glyceryl Isopalmitate, Glyceryl Isostearate, Glyceryl Isostearate/Myristate, Glyceryl Isostearates, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Montanate, Glyceryl Myristate, Glyceryl lsotridecanoate/Stearate/Adipate, Glyceryl Oleate SE, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Palmitate/Stearate, Glyceryl Palmitoleate, Glyceryl Pentadecanoate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Sesquioleate, Glyceryi/Sorbitol Oleate/Hydroxystearate, Glyceryl Stearate/Acetate, Glyceryl Stearate/Maleate, Glyceryl Tallowate, Glyceryl Thiopropionate, and Glyceryl Undecylenate.
GLP compliance:
no
Type of study:
other: see summary
Justification for non-LLNA method:
Information on these in vivo studies was already available
Specific details on test material used for the study:
no details available
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Glyceryl esters of long-term saturated fatty acids are not sensitizing to the skin
Executive summary:

Glyceryl isostearate was evaluated in the maximization test. After induction, ten guinea pigs were challenged with 50% glyceryl isostearate in polyethylene glycol (PEG) and microcrystalline cellulose (MCC). Two additional challenges were also conducted. The first challenge yielded one and two positive reactions (all slight reactions) at 24 and 48 h, respectively. These results were confirmed by reactions observed after the third challenge.

 

The skin sensitization potential of glyceryl laurate was evaluated in the maximization test. Guinea pigs were subjected to four sensitizing injections of 2% glyceryl laurate and then challenged with intradermal injections of 0.8% glyceryl laurate and topical applications of 25% glyceryl laurate. No positive reactions were observed. In another maximization test, skin sensitization was induced in 2 of I 0 guinea pigs challenged with a 10% dilution of 20% glyceryl laurate emulsion. When a second challenge was initiated 7 days after the first, positive reactions were observed in five animals. Positive reactions were also observed in four animals challenged with a 5% dilution of 20% glyceryl laurate emulsion. Because positive reactions were also noted in the control group after the first and second challenge, the results were attributed to skin irritation (but not sensitization) effects of the test substance.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data were generated before the LLNA test became available
Species:
guinea pig
Strain:
Hartley
Sex:
female
Route:
intradermal
Vehicle:
other: olive oil/acetone (7/3)
Concentration / amount:
0.2%
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
not indicated
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 µL at 100%
Day(s)/duration:
24 hours
No. of animals per dose:
4
Details on study design:
The test was performed according to the method of Magnusson and Kligman. A total of 19 guinea pigs were used. For sensitization, the solution for injection was prepared by mixing equal volumes of Freund's complete adjuvant and distilled water using two 5-mL glass syringes and stainless-steel syringe connector. The substance was diluted with olive oil and acetone (7: 3 v/v) at concentrations of 0.2% by weight. In the first stage of induction, 50 µL of the formulation was intradermally injected into the back skin near the neck. One week later, as the second stage of induction, a filter paper patch soaked in 0.2 mL (100%) of the formulation was placed onto the shaved back of the guinea pigs. Finally, the pure substance (100 µL and 100% each) were applied to the skin at two sites using an Eppendorf filter paper under a sealed dressing for challenge for 24 hours.
Positive control substance(s):
no
Reading:
1st reading
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not sensitizing in a maximisation test
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The data on the analogues and the hydrolysis product ethylene glycol are indicative for no sensitizing properties of Fatty acids, C18-36 esters with ethylene glycol.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the information available the substance does not need to be classified for sensitization according to Regulation (EC) No 1272/2008 (CLP).