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EC number: 428-710-1 | CAS number: 207574-76-3
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 428-710-1
- EC Name:
- -
- Cas Number:
- 207574-76-3
- Molecular formula:
- C46H68N6O6 / C48H72N6O6 / C50H76N6O6 / C52H80N6O6 / C54H84N6O6
- IUPAC Name:
- Condensation products of m-phenylenebis(methylamine) with condensation products of 4-methyl-m-phenylene diisocyanate with alcohols, C10-14 (even numbered)
- Details on test material:
- - Physical state: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.2 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- Readings of eye alterations were made after 1, 2, 4, 8, 24, 48, 72 hours.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Before and after the test, the eyes of all animals were examined under UV. After weighing (16 hours starved) 0.1 g of the substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
The eye lesions were scored according to the system of Draize.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was not removed
SCORING SYSTEM:
1. Cornea
a) Degree of opacity (A):
- No opacity (nor loss of brilliancy or lustre): 0
- Presence of an irritated area of diffused or disseminated appearance, details of the iris clearly visible: 1
- Presence of a translucid, irritated area easily identifiable, details of the iris slightly obscured: 2
- Presence of an opalescent, irritated area, details of the iris visible, outline of the pupil can scarcely be observed: 3
- Presence of opacity making the iris invisible: 4
b) Area of opacity (B):
- 1/4 (or less), but not zero: 1
- Between 1/4 and 1/2: 2
- Between 1/2 and 3/4: 3
- From 3/4 to the whole area: 4
The total mark is determined by multiplying the two scores by 5: A X B x 5 (maximum = 80)
2. Iris (C)
- Normal: 0
- Clearly more plicate than normal, congestion, swelling circumcorneal injection (one or several of these characteristics), iris still reacting to light (a slow reaction is a positive reaction): 1
- No reaction to light, heamorrhage, significant "destruction" (one, several or all of these characteristics): 2
The total mark is determined by multyplying the score by 5: C x 5 (maximum = 10)
3. Conjunctiva, Chemosis and Lacrimation
a) Conjuctiva (D):
- Reddening of the palpebral conjunctiva: vessels normal: 0
- Vessels clearly more injected than normal: 1
- Bright red colour, more diffuse, vessels difficult to distinguish: 2
- Diffuse blood red colour: 4
b) Chemosis (E):
- No swelling: 0
- Slight swelling, including the nictating membrane: 1
- Pronounced swelling, with inversion of the eyelid: 2
- Swelling with eyelids half closed: 3
- Swelling with eyelid closed more than half-way or completely closed: 4
c) Lacrimation (F):
- Absence: 0
- Slight lacrimation (do not take into account slight secretions normally in the inside corner): 1
- Lacrimation with moistening of the eyelids and hairs around the eyelids: 2
- Lacrimation with moistening of the eyelids and heirs on wide areas around the eye: 3
The total mark is determined by adding the three scores and multiplication of the sum by 2: (D + E + F) x 2 (maximum = 20)
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: iridal changes were not evident
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Some conjunctiva redness (up to scores of 2) and some lacrimation were observed in all rabbit until 8h after application
- Other effects:
- Body weights and body weight gains were normal in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to Regulation (EC) 1272/2008.
- Conclusions:
- Based on the results and according to the EC criteria for classification and labelling according to GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement as irritating to eyes.
- Executive summary:
As no eye reaction were observed in a GLP study acc. to OECD guideline no. 405 at 24, 48 and 72 h,
the test item is considered as not eye irritating.
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