Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Principles of method if other than guideline:
Patch test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, C16-18 mono-, di- and tri-
EC Number:
EC Name:
Glycerides, C16-18 mono-, di- and tri-
Cas Number:
Molecular formula:
C19H38O4; C21H42O4; C35H68O5; C39H76O5; C51H98O6; C57H110O6
Glycerides, C16-18 mono-, di- and tri-
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: 020903/1


Type of population:
- Number of subjects exposed: 50
- Sex: 15 males and 35 females
- Age: 28-69 (males) and 18-69 (females) years
- Diagnosis:
Healthy: 9 males and 22 females
Sensitive skin: 7 females
Atopic: 6 males and 6 females
Ethical approval:
not specified
Route of exposure:
Reason of exposure:
Exposure assessment:
Details on exposure:
The test substance, diluted to 25% in paraffin oil, was applied once at 2 mg test substance/cm² to healthy skin on the back area of the test subjects using a commercial test patch. The patch was removed 48 h post-application.
- Skin reactions: skin reactions were evaluated immediately after patch removal (48 h post-application) and 24 h later (72 h post-application).
- Scoring system:
0: no irritation
±: slight or doubtful erythema
+: clearly recognisable erythema
++: strong erythema and/or papulation
+++: densly aggregated papules and/or vesicles
++++: blistering or necrosis

Results and discussion

Clinical signs:
No positive or doubtful skin reactions were observed at 48 and 72 h post-application in any subject. Thus, there was no indication that the test substance acts as a primary skin irritant. Furthermore, no skin reactions resulting from an existing sensitisation were induced in this test.

Applicant's summary and conclusion

Not irritating. No evidence of an already existing sensitisation.