Hydroxyoctadecanoic acid, monoester with glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US FHSA. 16 CFR 1500.41

Deviations:

yes

Remarks:

No reading at 48 hours after administration of test material

Principles of method if other than guideline:

Procedure used was based on the Draize procedure as required in US FHSA, 16 CFR 1500.41

GLP compliance:

not specified

Remarks:

predatees establishment of GLP

Test material

Test material information

Constituent 1

Test material form:

semi-solid (amorphous): gel

Details on test material:

Cream colored semisolid; Paricin 13 (TM), Vertellus Inc.

Specific details on test material used for the study:

Substance Name: GMHS, Glyceryl Monohydroxystearate, CAS#: 1323-42-8, EC#: 215-355-9 IUPAC: 2-hydroxy-1-(hydroxymethyl)ethyl 2-hydroxyoctadecanoate Cream colored semisolid

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Six albino rabbits were selected from healthy, acclimated animals.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: The back was shaved and the skin was abraded on the right side. The skin remained intact on the left half of the back.

Vehicle:

unchanged (no vehicle)

Controls:

no

not specified

Amount / concentration applied:

0.5g was applied to the skin on both halves of the back.

Duration of treatment / exposure:

Exposure of the substance occurred for 24 hours and was then removed from the skin. The sites of exposure were observed for 72 hours.

Observation period:

Observation occured at 24 and 72 hours after the substance was applied.

Number of animals:

Six

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.29

Max. score:

8

Reversibility:

not specified

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

Of the animals demonstrating irritation, most showed barely perceptible to very slight erythema or edema. Only one animal, in the portion of the skin which was abraded, showed clearly defined erythema/eschar formation. The overall average of all animals is an irritation score of 1.29, including scores in abraded skin. Concerning readings in intact skin only, only 2 animals displayed erythema (maximal observed value of 1), and only 1 animal displayed edema (max observed value of 1).

Any other information on results incl. tables

Findings of the study:

Findings	Exposure Time (Hours)	Exposure Unit (Value)
		Rabbit No.
		1       2      3        4       5       6
Erythema and eschar formation:
Intact Skin	24	1	0	0	0	1	1
Intact Skin	72	0	0	0	0	1	1
Abraded Skin	24	1	1	1	1	1	1
Abraded Skin	72	1	1	1	1	2	1
Subtotal……		3	2	2	2	5	4
Edema Formation:
Intact Skin	24	0	0	0	0	0	0
Intact Skin	72	0	0	0	0	0	1
Abraded Skin	24	0	1	1	1	1	1
Abraded Skin	72	2	1	1	1	1	1
Subtotal…..		2	2	2	2	2	3
Total…………		5	4	4	4	7	7
Score………..		1.25	1.00	1.00	1.00	1.75	1.75
Average = 1.29

 

Draize Scoring Criteria:

Primary Skin Irritation Indexes of less than 2.0 are mild irritants.

Primary Skin Irritation Indexes of 2.0 to 5.0 are moderate irritants.

Primary Skin Irritation Indexes of greater than 5.0 are severe irritants.

Findings	Exposure Time (Hours)	Exposure Unit (Value)
		Rabbit No.
		1       2      3        4       5       6
Erythema and eschar formation:
Intact Skin	24	1	0	0	0	1	1
Intact Skin	72	0	0	0	0	1	1
Abraded Skin	24	1	1	1	1	1	1
Abraded Skin	72	1	1	1	1	2	1
Subtotal……		3	2	2	2	5	4
Edema Formation:
Intact Skin	24	0	0	0	0	0	0
Intact Skin	72	0	0	0	0	0	1
Abraded Skin	24	0	1	1	1	1	1
Abraded Skin	72	2	1	1	1	1	1
Subtotal…..		2	2	2	2	2	3
Total…………		5	4	4	4	7	7
Score………..		1.25	1.00	1.00	1.00	1.75	1.75
Average = 1.29

 

Draize Scoring Criteria:

Primary Skin Irritation Indexes of less than 2.0 are mild irritants.

Primary Skin Irritation Indexes of 2.0 to 5.0 are moderate irritants.

Primary Skin Irritation Indexes of greater than 5.0 are severe irritants.

Erythema was observed in the intact skin and abraded skin of three animals, and only in the abraded skin of three additional animals. Erythema in the intact skin of one animal cleared during the 72 -hour observation period. Edema was observed in the intact and abraded skin of one animal, and in the abraded skin of five additional animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

The overall score of 1.29 is below the value of 2.3 or higher in intact skin, as required for classification according to the CLP.

Conclusions:

On the basis of the data presented, the substance is mildly irritating to the skin of rabbits. The degree of irritation does not meet the criteria for classification as a skin irritant according to CLP, Regulation EC No. 1272/2008.