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EC number: 217-442-7 | CAS number: 1852-16-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June 2006 to 13 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Instead of one eye remaining untreated and serving as control, both eyes were treated and one was rinsed.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(butoxymethyl)acrylamide
- EC Number:
- 217-442-7
- EC Name:
- N-(butoxymethyl)acrylamide
- Cas Number:
- 1852-16-0
- Molecular formula:
- C8H15NO2
- IUPAC Name:
- N-(butoxymethyl)prop-2-enamide
- Test material form:
- liquid
- Details on test material:
- - Physical state: Clear liquid
- Storage conditions of test material: Room temperature and humidity. Avoid prolonged storage above 100 °F.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: The pre-test body weight range was 2.6 - 3.0 kg
- Age at study initiation: Approximately 14 weeks
- Housing: The animals were housed 1 per cage in suspended cages. Bedding was placed beneath the cages and changed at least three times per week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Equilibrated for at least three days
ENVIRONMENTAL CONDITIONS
- Temperature: Not reported, the room was temperature controlled
- Photoperiod: 12 hour light / dark cycle
IN-LIFE DATES:
- From: 07 June 2006
- To: 03 July 2006
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Initially, the right eye of one rabbit was dosed. Since no discomfort was noted at the time of dosing, the left eye and both eyes of the remaining two rabbits were dosed. The test article was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together briefly to ensure adequate distribution of the test article.
VEHICLE
The test material was used as supplied.
OTHER
Prior to the start of the test, both eyes of each animal were examined for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. - Duration of treatment / exposure:
- - Left eye: 20-30 seconds prior to washing
- Right eye: Test material was not removed - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 rabbits; one male and two female.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed.
- Time after start of exposure: Twenty to thirty seconds after instillation of the test article.
SCORING SYSTEM:
Ocular reactions were graded according to the numerical Draize technique. Both eyes of each rabbit were examined for irritation of the cornea, iris and conjunctiva at one hour post-dose, and at 24, 48 and 72 hours post-dose. The eyes were scored again on Day 7. Additional signs were described.
CORNEA
Opacity: degree of density (area most dense is taken for reading).
0: No opacity
1: Scattered or diffuse areas of opacity, details of iris clearly visible
2: Easily discernible translucent area, details of iris slightly obscured
3: Opalescent area, no details of iris visible, size of pupil barely discernible
4: Opaque, iris invisible
IRIS
0: Normal
1: Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) still reacting to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any of all these or all together)
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae excluding cornea and iris)
0: Vessels normal
1: Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
0: No swelling
1: Any swelling above normal (includes nictating membranes)
2: Obvious swelling with partial eversion of lids.
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed
Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs a considerable area around the eye
TOOL USED TO ASSESS SCORE:
A Mini Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination.
OTHER
Body weights were recorded pre-test. The general health of the animals was monitored at each observation time. All animals were humanely scarified using CO2 following study termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable - no effects observed
- Remarks on result:
- other: Based on unwashed eyes only.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable - no effects observed
- Remarks on result:
- other: Based on unwashed eyes only.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable - no effects observed
- Remarks on result:
- other: Based on unwashed eyes only.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Based on unwashed eyes only.
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable - no effects observed
- Remarks on result:
- other: Based on unwashed eyes only.
- Irritant / corrosive response data:
- - Unwashed eyes: There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation was noted in 3/3 eyes which cleared within 48 hours.
- Washed eyes: There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation was noted in 3/3 eyes which cleared by Day 7. - Other effects:
- One instance of diarrhoea was the only abnormal physical sign noted during the observation period.
Any other information on results incl. tables
Table 1: Ocular Findings in Right Eye - Unwashed
Animal No. |
Tissue |
Reading |
1 h |
24 h |
48 h |
72 h |
7 Days |
G8728 M |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
G8760 F |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
2 |
0 |
0 |
0 |
0 |
||
G8761 F |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
Table 2: Ocular Findings in Left Eye - Washed
Animal No. |
Tissue |
Reading |
1 h |
24 h |
48 h |
72 h |
7 Days |
G8728 M |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
G8760 F |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
2 |
2 |
1 |
0 |
|
Chemosis |
1 |
2 |
1 |
0 |
0 |
||
G8761 F |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
2 |
1 |
1 |
0 |
|
Chemosis |
1 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The test material is not irritating to eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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