1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

no

Remarks:

The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

EC Number:

205-363-0

EC Name:

1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]

Cas Number:

139-43-5

Molecular formula:

C63H116O12

IUPAC Name:

1,3-bis({[12-(acetyloxy)octadecanoyl]oxy})propan-2-yl 12-(acetyloxy)octadecanoate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Details on study design:

Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 milliliter of the test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 20, 48, and 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as received.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

0

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Any other information on results incl. tables

Group	Draize scores
	24 h	48 h	72 h	4 d	7 d
Unwashed	0.3	0	0	-	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not an ocular irritant to rabits under the conditions of the test.

Executive summary:

In this guideline equivalent study (EPA OPP 81 -4), conducted prior to the adoption of the OECD principles of GLP in 1992, the test material (EC 205-363-0) was not considered an ocular irritant to the rabbit. Six New Zealand White rabbits were treated with 0.1ml of the unchanged substance in one eye, the contralateral eye served as a control. Rabbits were observed for corneal opacity, iritis, and conjunctivitis at 24, 48, and 72 hours after treatment, and again 4 day and 7 days after treatment. Results were scored accoring to the Draize criteria. The test material induced a mean overal irritation score of 0.3 at 24 hours, this was fully reversible at the 48 hour observation.