Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 June 1991 - 8 June 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene distearate

EC Number:

211-014-3

EC Name:

Ethylene distearate

Cas Number:

627-83-8

Molecular formula:

C38H74O4

IUPAC Name:

ethane-1,2-diyl dioctadecanoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1g

Duration of treatment / exposure:

Following instillation the animals were returned to their respective cages for 24 hours. The eyes were not washed out following instillation.

Observation period (in vivo):

Ocular lesions were evluated 24, 48 and 72 hours post-administration.

Number of animals or in vitro replicates:

3 Males and 3 females.

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Time point:

24 h

Score:

3

Reversibility:

other: Partially reversible within 72 hours

Remarks on result:

probability of mild irritation

Other effects:

All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation.

Any other information on results incl. tables

Incidence of Irritation

	Corneal Opacity	Iritis	Conjunctival Irritation
24 hours	0/6	0/6	6/6
48 hours	0/6	0/6	4/6
72 hours	0/6	0/6	2/6

Severity of Irritation

	Maximum Mean Irritation Score
24 hours	3 (minimally irritating)
48 hours	1.3 (practically non-irritating)
72 hours	0.7 (practically non-irritating)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the scoring system used in this study the substance is considered to be minimally irritating to eyes.

Executive summary:

The irritant or corrosive of a single dose of the substance into the eyes of New Zealand White rabbits (3/sex) was investigated in this in vivo study. One eye of each rabbit was instilled with 0.1g of the test substance and irritation was scored at 24, 48 and 72 hours administration. All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation. The 24 hour Maximum Mean Total Score was 3 and based on this score the substance is considered to be minimally irritating to eyes.