Glycerides, C8-10 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:

weight of evidence

Study period:

5 Jul - 9 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP -Guideline study with acceptable restrictions. Lack on test material details.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

yes

Remarks:

lack on test material details.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

Molecular formula:

C27H50O6 to C33H62O6

IUPAC Name:

Glycerides, mixed decanoyl and octanoyl

Details on test material:

- Name of test material: only trade name given
- Physical state: pale straw-coloured clear liquid
- Analytical purity: no data
- Date of arrival: 1988-03-23
- Storage conditions: room temperature

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: 2.76-3.34 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 65-75
- 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 applied: 0.1 mL

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:

4 females and 2 males

Details on study design:

SCORING SYSTEM: Draize scoring system modified version by Kay and Calandra

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 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 all 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 all 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0.06

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean after 24/48/72 h

Score:

0.06

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

- Cornea: no adverse corneal effects were noted in any animal.
- Iris: 1 h after treatment iridial inflammation in 1/6 animals were observed. 24, 48 and 72 h no iridial effects were observed in any animal.
- Conjunctivae: mild to moderate conjunctivae effects were apparent in 6/6 animals 1 h after instillation. In 1/6 animals mild conjunctivae redness and chemosis was still apparent after 24 h being reversible after 48 h. In the remaining 5/6 animals conjunctivae irritation was fully reversible within 24 h.

Other effects:

No further local or system 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	1	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.33	0	0
2	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
3	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
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	2	1	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	1.50	1.00	0	0
	24	0.17	0.17	0	0
	48	0	0	0	0
	72	0	0	0	0
	24+48+72	0.06	0.06	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