Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 December 1985 to 3 January 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur
EC Number:
306-111-3
EC Name:
9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur
Cas Number:
96152-40-8
IUPAC Name:
9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur
Test material form:
liquid: viscous
Details on test material:
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, France
- Weight at study initiation: 2.5 kg ± 200 g
- Housing: individually
- Diet: 150 g complete maintenance food (112 UAR) per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
- Dose administration: Approximately 0.1 mL of the test material was instilled into the conjunctival sac of the right eye of each rabbit. The lids were then gently held together for 10 seconds to avoid any loss of the test material. The other eye was untreated (control eye). Animals were restrained for a period of 1 hour post administration before being replaced in their individual cages.
Observation period (in vivo):
Animals were observed up to 72 hours post administration
Number of animals or in vitro replicates:
6 males were used for the study.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was not performed

SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1959). See "Any other information on materials and methods incl. tables" for further information.

TOOL USED TO ASSESS SCORE: To aid scoring, an ophthalmoscope was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
80
Reversibility:
other: not applicable
Remarks on result:
other: No effects on cornea observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.28
Max. score:
10
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.61
Max. score:
20
Reversibility:
fully reversible within: 3 days

Any other information on results incl. tables

Table 2: Results

Reading (h)

Rabbit

Conjunctivae

Iris

Cornea

Chemosis

Redness

Degree of opacity

Area of opacity

1

1

1

2

1

0

0

2

2

2

1

0

0

3

2

2

1

0

0

4

2

2

1

0

0

5

2

2

1

0

0

6

2

2

1

0

0

24

1

0

1

1

0

0

2

0

1

1

0

0

3

1

1

0

0

0

4

1

1

0

0

0

5

1

1

1

0

0

6

1

1

1

0

0

Mean

0.67

1.00

0.67

0.00

0.00

48

1

0

0

0

0

0

2

0

1

1

0

0

3

0

0

0

0

0

4

0

0

0

0

0

5

0

0

0

0

0

6

0

0

0

0

0

Mean

0.00

0.17

0.17

0.00

0.00

72

1

0

0

0

0

0

2

0

0

0

0

0

3

0

0

0

0

0

4

0

0

0

0

0

5

0

0

0

0

0

6

0

0

0

0

0

Mean

0.00

0.00

0.00

0.00

0.00

Mean 24 h + 48 h + 72 h

0.22

0.39

0.28

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. During the study, approximately 0.1 mL test material was instilled into the right conjunctival sac of each of six rabbits; the left eye remained untreated and served as the control. The animals were assessed for up to 72 hours following test material administration to determine the grade of ocular reaction. There were no corneal effects. Conjunctival effects consisted of slight redness and slight chemosis in all animals up to 24 hours after application. In addition, one animal had slight erythema 48 hours after application. In addition, slight iridial effects were noted in all animals 1 hour after instillation and persisted for 24 hours in 4 animals and for 48 hours in 1 animal. All signs of irritation had completely resolved within 72 hours of application.

Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study such that the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.