Hydroxyoctadecanoic acid, monoester with glycerol

Eye irritation

Administrative data

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

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 1500.42

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

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

Physical state/Appearance: Off-white solid
Batch: 0000149116
Purity: >80%
Expiry Date: 28 October 2017
Storage Conditions: Room temperature in the dark

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.

Test animals / tissue source

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.

Test system

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

Results and discussion

In vivo

Results

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.