Glycerides, C12-18 mono- and di-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

30 Jun - 04 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions. Purity of test substance not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

yes

Remarks:

purity of test substance not given

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

purity of test substance not given

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C12-18

EC Number:

266-944-2

EC Name:

Glycerides, C12-18

Cas Number:

67701-26-2

Molecular formula:

C39H74O6 to C57H110O6

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.52-2.99 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Humidity (%): 60-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (= 97 mg)
The material was warmed until molten and instilled in the eye in the form of a paste.

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

5 males, 1 female

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 24 h in 4/6 animals and 48 h in 2/6 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No corneal opacity, iritis or chemosis were observed in any animal at any reading time point.
1 h post-instillation: slight or moderate conjunctval redness was observed in 2/6 and 4/6 animals respectively. Slight or moderate chemosis was observed in 4/6 and 1/6 animals, respectively. Slight discharge was observed in 4/6 animals.
24 h post-instillation: slight conjunctival redness was observed in 2/6 animals, the effect being fully reversible within the following 24 h.
48-72 h post-instillation: no conjunctival redness was observed in any animal.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of eye irritation study

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	chemosis
1	1	2	2	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
2	1	2	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
3	1	2	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
4	1	1	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
5	1	2	1	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
6	1	1	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.67	1	0	0
	24	0.33	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	24+48+72	0.11	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified