Hydroxyoctadecanoic acid, monoester with glycerol

Endpoint summary

Description of key information

Not irritating according to the CLP

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Six albino rabbits were selected from healthy, acclimated animals.

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

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).

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Experimental studies were performed in a laboratory prior to establishment of international guidelines and GLP

Qualifier:

according to guideline

Guideline:

other: US FHSA, 16 CFR 1500.42

Principles of method if other than guideline:

This study was performed according to the procedure described in the US FHSA regulation, in 16 CFR 1500.42. This utilizes 6 animals with evaluation according to the Draize Scale.

GLP compliance:

not specified

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. The substance used in the test study was a cream colored semi-solid.

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

The study was determined on six young adult albino rabbits selected from healthy, acclimated animals.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The standard for the Draize study is 0.1g.

Duration of treatment / exposure:

Ocular reactions of the substance was observed and recorded at 24, 48, and 72 hours, and again at 7 days after the instillation of the test material.

Observation period (in vivo):

The observation period of the test material occured over 7 days.

Number of animals or in vitro replicates:

6 young adult albino rabbits were used.

Details on study design:

Study design was based on the Draize method

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

1.3

Max. score:

110

Reversibility:

fully reversible within: 7 Days

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

The substance showed a mean scorefor conjunctiva of 1.3 out of 110. There was no evidence of corneal opacity or iritis. No conjunctival erythema score was greater than 2. Out of the six rabbits tested, four showed conjunctival erythema at 24 hours, two at 48 hours and 1 at 72 hours. The effects fully cleared by the end of the 7 day observation period.

Findings of the study:

Rabbit No. & Sex	Item	Tissue	24 Hours	48 Hours	72 Hours	7 days
1	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Total = (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total = (C) x 5	0	0	0	0
	D	Conjunctiva Redness	1	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Tota l= (D+E+F) x 2	2	0	0	0
		Totals Added = (1+2+3)	2	0	0	0
2	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Tota l= (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total = (C) x 5	0	0	0	0
	D	Conjunctiva Redness	1	1	0	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Total = (D+E+F) x 2	2	2	0	0
		Totals Added = (1+2+3)	2	2	0	0
3	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Total = (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total = (C) x 5	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Total = (D+E+F) x 2	0	0	0	0
		Totals Added = (1+2+3)	0	0	0	0

4	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Total = (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total= (C) x 5	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Total = (D+E+F) x 2	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0
5	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Total = (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total = (C) x 5	0	0	0	0
	D	Conjunctiva Redness	1	1	0	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Total = (D+E+F) x 2	2	2	0	0
		Totals Added = (1+2+3)	2	2	0	0
6	A	Cornea Opacity	0	0	0	0
	B	Cornea Area	0	0	0	0
		(1) Cornea Total = (AxB) x 5	0	0	0	0
	C	Iris	0	0	0	0
		(2) Iris Total = (C) x 5	0	0	0	0
	D	Conjunctiva Redness	1	1	1	0
	E	Conjunctiva Chemosis	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0
		(3) Conjunctive Total = (D+E+F) x 2	2	2	2	0
		Totals Added = (1+2+3)	2	2	2	0

Interpretation of results:

GHS criteria not met

Remarks:

Conjunctival erythema scores are less than 2.0; corneal and iris effects were not observed

Conclusions:

The substance is not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance displayed mild irritation to skin or eye, which, in either case, did not qualify for classification as irritants according to the ECHA Guidance on the interpretation of the CLP criteria (ver 5.0, 2015). The criteria for classification according to Regulation EC No. 1272/2008 are not met and the substance is not classified.