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EC number: 306-111-3 | CAS number: 96152-40-8
Eye irritation
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:
- 1 986
- 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
- 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
Constituent 1
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.
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