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EC number: 247-728-7 | CAS number: 26479-35-6
Eye irritation
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:
- other: Study performed according to GLP/OECD guideline without deficiency.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium carbamoylcarbamate
- EC Number:
- 247-728-7
- EC Name:
- Potassium carbamoylcarbamate
- Cas Number:
- 26479-35-6
- Molecular formula:
- C2H4N2O3.K
- IUPAC Name:
- potassium N-carbamoylcarbamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Potassium Allophonate
- Physical state:powder
- Analytical purity:83.8%
- Storage condition of test material: Room temperature 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:Male New Zealand White rabbits from Harlan UK Ltd, Bicester (HsdIf:NZW strain).
- Age at study initiation:Approximately 12 weeks old.
- Weight at study initiation:2.3 to 2.7 kg
- Housing:Rabbits were individually housed.
- Diet (e.g. ad libitum):Global Diet 2930C (Harlan Teklad, Bicester, UK), ad libitum.
- Water (e.g. ad libitum):Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):15 to 21 degrees C
- Humidity (%):Humidity did not fall below the limit specified in the protocol (45%).
- Air changes (per hr):15 to 20
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From 19 March 2012 to 30 March 2012.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg of powdered test article.
VEHICLE
- Amount(s) applied (volume or weight with unit):none - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The treated animals were examined for ocular changes approximately 30 minutes, one and four hours after treatment and on Days 2, 3 and 4 (at
approximately 24, 48 and 72 hours post treatment). - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):no
SCORING SYSTEM:
-The "initial sting" response was assessed and recorded immediately after instillation of the test article on Day 1.
The response was graded according to the following scheme:
Response of animal Grade Sting response
No response 0 None
A few blinks only, normal within two minutes 1 Practically none
Rabbit blinks and attempts to open eye but reflex closes it 2 Slight
Rabbit keeps eye shut and puts pressure on it, may rub eye 3 Moderate
Rabbit holds eye tightly shut, may struggle or squeal 4 Marked
Grading of Ocular Reactions
CONJUNCTIVAE
Grade
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red appearance 3
(B) Chemosis (refers to lids and/or nictitating membrane)
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4
(C) Discharge
No discharge 0
Any discharge greater than normal (not including the small amount normally present in the inner canthus of normal animals) 1
Discharge with moistening of lids and hairs just adjacent to the lids 2
Discharge with moistening of lids and hairs for a considerable area around the eye 3
TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
IRIS (D) Grade
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection (any of these or any combination thereof); iris still reacting to light (a sluggish reaction is an effect) 1
Haemorrhage, gross destruction, no reaction to light (any or all of these) 2
TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
CORNEA Grade
(E) Degree of opacity (most dense area used)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible 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 opacity 4
(F) Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter but not more than half 2
Greater than half but not more than three quarters 3
Greater than three quarters, up to whole area 4
TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0.5 h, 1 h
- Score:
- 6.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 0.5 h, 1 h
- Score:
- 6.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: maximum group mean score (based on effects on the conjunctivae at 1 hour)
- Irritant / corrosive response data:
- - There were no corneal or iridial effects noted.
- Minimal to moderate conjunctival irritation was noted in all treated eyes 0.5 and 1 hour after instillation, with minimal conjunctival irritation persisting in two treated eyes 4 hours after instillation. No signs of irritation were observed at 24, 48 or 72 hours.
- The eyes of all rabbits were overtly normal by the 24 hour examination.
Any other information on results incl. tables
Table1
Rabbit number, sex , initial and final body weights |
7 Male (2..3 - 2.4 kg) |
8 Male (2.7 - 2.6 kg) |
9 Male (2.6- 2.6 kg) |
|||||||||||||||
Initial sting response = 2 |
Initial sting response = 2 |
Initial sting response = 2 |
||||||||||||||||
Time after treatment |
½ hr |
1 hr |
4 hrs |
24 hrs* |
48 hrs* |
72 hrs |
½ hr |
1 hr |
4 hrs |
24 hrs* |
48 hrs* |
72 hrs |
½ hr |
1 hr |
4 hrs |
24 hrs* |
48 hrs* |
72 hrs |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D = Reaction |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
B = Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
C = Discharge |
1 |
1 |
1 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
0 |
0 |
0 |
Score (A + B + C) X 2 |
4 |
4 |
2 |
0 |
0 |
0 |
8 |
8 |
0 |
0 |
0 |
0 |
8 |
8 |
4 |
0 |
0 |
0 |
Total Score |
4 |
4 |
2 |
0 |
0 |
0 |
8 |
8 |
0 |
0 |
0 |
0 |
8 |
8 |
4 |
0 |
0 |
0 |
Key:
* Fluorescein applied to cornea
Table2
Individual total scores and group mean scores
Rabbit Number and Sex |
Individual total scores at: |
|||
1 hour |
24 hours |
48 hours |
72 hours |
|
7 Male |
4 |
0 |
0 |
0 |
8 Male |
8 |
0 |
0 |
0 |
9 Male |
8 |
0 |
0 |
0 |
Group Total |
20 |
0 |
0 |
0 |
Group Mean Score |
6.7 |
0 |
0 |
0 |
Table3
Interpretation of results according to GHS
Rabbit Number and Sex |
Observation Time |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
|
7 Male |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
||
72 Hours |
0 |
0 |
0 |
0 |
||
Total |
0 |
0 |
0 |
0 |
||
Mean Score |
0 |
0 |
0 |
0 |
||
8 Male |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
||
72 Hours |
0 |
0 |
0 |
0 |
||
Total |
0 |
0 |
0 |
0 |
||
Mean Score |
0 |
0 |
0 |
0 |
||
9 Male |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
0 |
||
72 Hours |
0 |
0 |
0 |
0 |
||
Total |
0 |
0 |
0 |
0 |
||
Mean Score |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test article produced a maximum group mean score of 6.7 and was considered to be a minimal irritant according to the modified version of the
system described by Kay and Calandra.
The test article did not meet the criteria for classification as irritant according to the Globally Harmonized System of Classification and Labelling of
Chemicals (GHS).
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