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EC number: 203-714-2 | CAS number: 109-87-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Methylal
- IUPAC Name:
- Methylal
- Details on test material:
- - Name of test material (as cited in study report): Methylal
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): commercial diet ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 and 0.1 ml
- Concentration (if solution): Not specified
VEHICLE
- Amount(s) applied (volume or weight with unit): Not specified
- Concentration (if solution): Not specified
- Lot/batch no. (if required): Not specified
- Purity: Not specified - Observation period (in vivo):
- Scoring is recorded at 1 hour; 4-6 hours; 1 day; 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 6 females per dose
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: Not specified
SCORING SYSTEM: the scale used for scoring ocular lesions is more detailed than the one OECD 405. Here, area of cornea involved and discharge are scored in comparison to OECD scale.
CORNEA
Opacity: degree of density (readings should be taken from most dense area)
"0"_No ulceration or opacity
"1"_Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
"2"_Easily discernible translucent area; details of iris slightly obscured
"3"_Nacrous area; no details of iris visible; size of pupil barely discernible
"4"_Opaque cornea; iris not discernible through the opacity .
* The area of corneal opacity should be noted
Area of cornea involved
"1"_One-quarter or less, but not zero
"2"_Greater than one-quarter, but less than half
"3"_Greater than half, but less than three-quarter
"4"_Greater than three-quarter, up to whole area
IRIS
"0"_Normal
"1"_Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect
"2"_Hemorrhage, gross destruction, or no reaction to light
CONJUNCTIVAE
(A) Redness
"0"_Vessels normal
"1"_Vessel definitely injected above normal
"2"_Diffuse, deep crimson red, individual vessels not easily discernible
"3"_Diffuse beefy red
(B) Chemosis
"0"_No chemosis
"1"_Any swelling above normal (includes nictitating membrane)
"2"_Obvious swelling, with partial eversion of lids
"3"_Swelling, with lids about half closed
"4"_Swelling, with lids more than half closed
(C) Discharge
"0"_No discharge
"1"_Any amount of discharge different from normal
"2"_Discharge with moistening of the lids and hairs adjacent to lids
"3"_Discharge with considerable moistening around the eyes
TOOL USED TO ASSESS SCORE: fluorescein (2%) is used to determine corneal injury before dosing and at raeading after 1 day.
Results and discussion
In vitro
Results
- Remarks on result:
- not measured/tested
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 mL
- Basis:
- animal: #1, 2, 3, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 mL
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 mL
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 mL
- Basis:
- animal: #1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 mL
- Basis:
- animal: #1, 2, 3, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 mL
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 mL
- Basis:
- animal: #1, 2, 3, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 mL
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.01 mL
- Basis:
- animal: #7 to 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.01 mL
- Basis:
- animal: #7 to 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.01 mL
- Basis:
- animal: #7 to 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.01 mL
- Basis:
- animal: #7 to 12
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The volume of 0.1 ml of test substance into rabbit eyes produced minor corneal and iris injury in 3/6 eyes, persisting through 3 days in one. Minor to moderate conjunctival irritations was recorded in 5 eyes and persisted in one through 2 days. Application of 0.01 ml of Methylal induced no corneal and iris injury and minor transient conjunctival irritation in 4/6 eyes. By one day, all eyes had a normal appearance.
Eyes score table is shown below. Values are indicated as range scores (mean score)
Volume instilled : 0.1 ml |
|||||||
Observations |
|
1 hour |
4 -6 hours |
24 hours |
48 hours |
72 hours |
7 days |
Cornea |
Opacy |
0 to 1 (0.5) |
0 to 1 (0.5) |
0 to 1 (0.3) |
0 to 1 (0.2) |
0 to 1 (0.2) |
All 0 (0.0) |
Cornea |
Area |
- |
- |
0 to 3 (0.8) |
0 to 1 (0.2) |
0 to 1 (0.2) |
All 0 (0.0) |
Iris |
Injury |
0 to 1 (0.5) |
0 to 1 (0.7) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
Conjunctivae |
Redness |
0 to 1 (0.8) |
0 to 1 (0.8) |
0 to 1 (0.2) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
Conjunctivae |
Chemosis |
0 to 3 (2.0) |
0 to 3 (2.0) |
0 to 1 (0.2) |
0 to 1 |
All 0 (0.0) |
All 0 (0.0) |
Conjunctivae |
Discharge |
0 to 3 (2.0) |
0 to 3 (2.2) |
0 to 1(0.2) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
Volume instilled : 0.1 ml |
|||||||
Observations |
1 hour |
4 -6 hours |
24 hours |
48 hours |
72 hours |
7 days |
|
Cornea |
Opacy |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Cornea |
Area |
- |
- |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Iris |
Injury |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Conjunctivae |
Redness |
0 to 1 (0.3) |
0 to 1 (0.5) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Conjunctivae |
Chemosis |
0 to 1 (0.3) |
0 to 1 (0.3) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Conjunctivae |
Discharge |
0 to 1 (0.5) |
0 to 1 (0.7) |
All 0 (0.0) |
All 0 (0.0) |
All 0 (0.0) |
- |
Applicant's summary and conclusion
- Interpretation of results:
- no data
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Application of 0.1 and 0.01 mL per rabbit eye induced minor to moderate eye irritation and mild transient conjunctival irritation, respectively.
According to CLP rules, methylal is not classified for eye irritation hazard. - Executive summary:
Methylal ability to produce eye irritation has been studied in New Zealand White rabbit. The test substance was applied at volume of 0.01 or 0.1 ml into the lower conjunctival sac of one eye per animal or is placed direcly on the eyes. The eyelids are held together for one second. Six female rabbits were used per dose level.
Injuries in cornea, iris and conjunctivae were recorded according to Grading of Ocular Lesions System at 1 hour; 4-6 hours; 1 day; 2, 3, 4 and 7 days.
The volume of 0.1 ml of test substance instilled into rabbit eyes produced minor corneal and iris injury in 3/6 eyes. Minor to moderate conjunctival irritations was recorded in 5 eyes and persisted in one through 2 days. Application of 0.01 ml of Methylal induced no corneal and iris injury and minor transient conjunctival irritation in 4/6 eyes. After one day, all eyes had a normal appearance.
Application of 0.1 and 0.01 ml per rabbit eye induced minor to moderate eye irritation and mild transient conjunctival irritation, respectively.
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