Docosanoic acid, monoester with glycerol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: Weight of evidence analysis based on expert evaluation 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:

Because of the structural and functional similarities, data from other glyceryl monoesters are also included in this weight of evidence assessment as supporting data.
The following expert opinion (attached in section 13) will be used in the weight of evidence approach:
CIR 2016: Cosmetic Ingredient Review. Safety assessment of monoglyceryl monoesters as used in cosmetics. Final amended report, January 15, 2016.

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:

In relation to the data requirements of REACH Annex VIII (10-100 t/y), data on acute toxicity must be provided. Limited data on this endpoint is available for docosanoic acid, monoester with glycerol (glycerol monobehenate).

Glycerol monobehenate is a mono-constituent substance. The main component is docosanoic acid, monoester with glycerol which is present in the product at a concentration of 80-97%; the remaining compounds are mainly fatty acids and monoesters of fatty acid and glycerol. Glycerol can also be present in a low concentration. Glyceryl monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides.

The acute toxicity of this substance is therefore assessed in the present document as a weight of evidence analysis based on existing data on groups of mono-, di- and triglycerides, fatty acids, which are all components with similar properties. Hereby, data is available for deriving a conclusion on the acute toxicity of the substance.

A weight of evidence approach is used for the assessment of the acute toxicity via oral, inhalation, and dermal route of exposure.

Test material

Test material information

Constituent 1

Reference substance name:

Docosanoic acid, monoester with glycerol

EC Number:

250-097-0

EC Name:

Docosanoic acid, monoester with glycerol

Cas Number:

30233-64-8

Molecular formula:

C25H50O4

IUPAC Name:

2-hydroxy-1-(hydroxymethyl)ethyl docosanoate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST MATERIAL
- Concentration (if solution):

Duration of exposure:

24 h

Doses:

5000 mg/kg

No. of animals per sex per dose:

4

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Collection of relevant data, please see attached document

Clinical signs:

other:

Applicant's summary and conclusion

Conclusions:

No irritation observed, no acute toxicity at the tested level

Executive summary:

Glycerol monobehenate is a mono-constituent substance. The main component is docosanoic acid, monoester with glycerol which is present in the product at a concentration of 80-90%; the remaining compounds are mainly fatty acids and monoesters of fatty acid and glycerol. Glycerol can also be present in a low concentration. Glyceryl monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides. 

From literature search, no specific data on the acute dermal toxicity of glycerol monobehenate was found. However, three studies conducted on other glycerol monoesters of fatty acids were found in an expert assessment from CIR (2016). 

Glyceryl Rosinate was administered to New Zealand white Rabbits at 5000 mg/kg bw or 10 000 mg/kg bw in water. The report LD50 in the two studies were 5000 and 10 000 mg/kg bw.   

Glycerides, C16-18 and C18-hydroxy mono- and di- was administered neat on Wistar rats at 2000 mg/kg bw. No irritation was observed and the LD50 was set at 2000 mg/kg bw. 

Based on the dermal studies identified in the CIR report, the expert panel concluded that the LD50 for glyceryl rosinate, and glycerides, C16-18 and C18-hydroxy mono- and di- are 10 000 mg/kg bw and 2000 mg/kg bw, respectively.  

The overall conclusion is therefore that monobehenate has low acute dermal toxicity with a LD50-value above 2000 mg/kg bw. Thus, classification for acute dermal toxicity according to (EC) No 1272/2008 is not warranted.