Registration Dossier
Registration Dossier
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EC number: 639-566-4 | CAS number: 165184-98-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from December 1993 to January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test is done following EU Directives Guidelines and under GLP. It also contains the Quality Assurance Statement and the substance is well characterised
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Hexyl cinnamic aldehyde
-Storage conditions: at 4 ºC in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK) Lt., Petersfield, Hampshire
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2.8 to 3.1 Kg
- Housing: they were housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx at 19 ºC
- Humidity (%): 30 to 70 %
- Air changes (per hr): approx 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours artificial light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each animal was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Unwashed
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- A total of three animals were used. One of the animals was treated in advance of the others, to ensure that if severe response was produced, no further animals would be exposed.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: not applicable
SCORING SYSTEM:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
Iris
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
Chemosis (lids and/or nictating membranes)
No swelling: 0
Any swelling above normal (includes nictating membranes): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritant / corrosive response data:
- See Table 7.3.2/1
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period
Any other information on results incl. tables
Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
| Rabbit number and sex | Region of eye | 1 h | Day after instillation | |||||
| 1 | 2 | 3 | 4 | 7 | ||||
| 2889 male | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 2 | 1 | 0 | 0 | 0 | 0 | |
| Chemosis | 2 | 0 | 0 | 0 | 0 | 0 | ||
| 2919 male | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 2 | 1 | 0 | 0 | 0 | 0 | |
| Chemosis | 1 | 0 | 0 | 0 | 0 | 0 | ||
| 2920 male | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 2 | 1 | 0 | 0 | 0 | 0 | |
| Chemosis | 2 | 0 | 0 | 0 | 0 | 0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, HCA is not classified for eye irritation according to the Annex VI of the CLP Regulation 1272/2008/EC and of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed according to the EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) and in compliance to the GLP, 0.1 mL of undiluted Hexyl cinnamic aldehyde (HCA) was instilled into the conjunctival sac of left eye of 3 male New Zeland White Rabbit. After the instillation the substance was not remained. Animals were then observed for 7 days.
The mean individual score were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean individual scores were 0/0/0 for cornea, iris and chemosis. The slight conjunctivae redness, observed (0.33/033/033) was completely reversible within 2 days.
Under the test conditions, HCA is not classified for eye irritation according to the Annex VI of the CLP Regulation 1272/2008/EC and of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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