Resin acids and Rosin acids, ammonium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Safety Assessment of Monoglyceryl Monoesters as Used in Cosmetics

Author:

Monice M. Fiume, Bart A. Heldreth

Year:

2015

Bibliographic source:

Cosmetic Ingredient Review, December 14-15, 2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of Glycerol esters of rosin in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, esters with glycerol

EC Number:

232-482-5

EC Name:

Resin acids and Rosin acids, esters with glycerol

Cas Number:

8050-31-5

IUPAC Name:

Glycerol esters of rosin

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):Glyceryl Rosinate
- IUPAC name: Resin acids and Rosin acids esters with glycerol
- Substance type:Organic
- Physical state:Solid
- Purity:No data available
- Impurities (identity and concentrations):No data available

Specific details on test material used for the study:

- Name of test material (as cited in study report):Glyceryl Rosinate
- IUPAC name: Resin acids and Rosin acids esters with glycerol, Glycerol esters of rosin
- Substance type:Organic
- Physical state:Solid
- Purity:No data available
- Impurities (identity and concentrations):No data available

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

semi-occlusive patch applied to intact skin; 0.5 g applied

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3

Details on study design:

no data available

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or edema was observed

Any other information on results incl. tables

 

Table: Results of the primary irritation study – dermal

Name of the test chemical	Concentration/ dose	Number of animals/ group	Procedure	Results
Glyceryl rosinate	No vehicle, but moistened with water, 0.5g	3 New Zealand White rabbits	4h semi occlusive patch, intact skin, 0.5 g applied to skin, animals were observed up to 72 hours	No erythema and no edema. Not irritating

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

No erythema or edema was observed in the rabbits during the 72 hour observation period.
Glycerol esters of rosin was considered to be not irritating to rabbit skin.

Executive summary:

The irritant effects on rabbit skin, was assessed for glyceryl rosinate. 3 New Zealand White Rabbits were subjected to a 4-h semi-occlusive patch test. 0.5 g test chemical was applied to intact skin, no vehicle was used but test chemical was moistened with distilled water. Animals were observed for up to 72 h

No erythema or edema was observed in the rabbits during the 72 hour observation period.

Glycerol esters of rosin was considered to be not irritating to rabbit skin.