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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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

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