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Registration Dossier
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EC number: 700-700-2 | CAS number: 1369492-55-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 June 2012 to 07 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
- EC Number:
- 700-700-2
- Cas Number:
- 1369492-55-6
- Molecular formula:
- C12H13Cl2NO
- IUPAC Name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.49 to 2.97 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15 changes /h
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of the undiluted test item, which was found to weigh approximately 62 mg
- Duration of treatment / exposure:
- Aftre instillation, the upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three male animals
- Details on study design:
- SCORING SYSTEM:
Draize Scale for Scoring Ocular Irritation
1. CONJUNCTIVAE
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
(B) Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids half closed to completely closed 4
(C) Discharge
No discharge 0
Any amount different from normal (does not include small
amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs a
considerable area around the eye 3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
(D) Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all 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
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
(E) Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4
(F) Area of Cornea Involved
One quarter (or less) but not zero 1
Greater than one quarter but less than half 2
Greater than half but less than three quarters 3
Greater than three quarters, up to whole area 4
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110
The 24h examination was performed under ultra-violet light following treatment with Sodium Fluorescein BP
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all three animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- other: all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Slight redness of the conjunctivae was noted in all animals at the 1h- and 24h- reading.
Slight chemosis was also noted in all animals at the 1h-reading in all animals and slight discharge was noted at the same observation period in two animals.
All reactions were fully reversible and the animals were clean after 48 hours.
Any other information on results incl. tables
The body weight of the animals were within the range for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not considered to be irritant for eye according the GHS criteria.
- Executive summary:
An in vivo eye irritation study was conducted with three male adult New Zealand rabbits according to OECD guideline 405.
0.1 mL of the test substance was instilled in the left eye of each animal and the animals were scored approximately 1, 24, 48 and 72 hours after instillation.
After single application of the test item to the non-irrigated eye of the three rabbits only minimal conjunctival irritation was noted. This included conjunctival redness, chemosis and discharge. All treated eyes appeared normal at the 48-Hour observation.
The test item is not considered to be irritant for the eyes according to GHS criteria.
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