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Registration Dossier
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EC number: 943-625-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-16 to 2001-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- EC Number:
- 241-523-6
- EC Name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- Cas Number:
- 17526-94-2
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Cas Number:
- 17607-23-7
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N"(4-Methyl-m-phenylen)bis(N',N'dimethylharnstoff)
- Substance type: organic
- Physical state: colourless solid
- Analytical purity:100%
- Purity test date: 01 March 2000
- Lot/batch No.: 023207
- Expiration date of the lot/batch: March 2003
- Storage condition of test material: store dry in closed containers
- Other: stable at dry storage conditions for at least 2 years
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: 4.7 kg, 4.3 kg, 3.0 kg
- Housing: Serni-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): at 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
The properly grind test item was used as delivered by the sponsor. - Duration of treatment / exposure:
- as long as observation period. The eyes were not washed after treatment.
- Observation period (in vivo):
- Animals were observed 72 h respectively and furthermore until the disappea rance ofthe symptoms. This was achieved at 48 h for animal No 375, at 96 h ofanimal No 358 and at 192 h for animal No 357.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, Lot H 901).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 144 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 1 - ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 192 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
Any other information on results incl. tables
Table 1: Individual eye irritation scores
Animal number |
Hour p.a. |
Cornea |
Iris |
Conjunctivae |
||
A |
B |
C |
||||
T/C |
T/C |
T/C |
T/C |
T/C |
||
357 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
1/0 |
0/0 |
2/0 |
0/0 |
0/0 |
|
72 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
120 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
144 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
168 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
192 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
358 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
375 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
T=Test, C=Control; A=Redness; B=Chemosis; C=Discharge;
marked figures=used for calculation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- On the basis of the results it is concluded that TDI-Urone is slightly irritating to the eyes of rabbits but not relevant for classification.
- Executive summary:
In a primary eye irritation study according to OECD 405 0.1 g TDI-Urone were applied unchanged into the conjunctival sac of 3 female New Zealand White rabbits (Crl:KBL (NZW) BR). Eyes were not washed after treatment. Animals were observed 72 h respectively and furthermore until the disappearance of the symptoms. This was achieved at 48 h for animal No 375, at 96 h of animal No 358 and at 192 h for animal No 357. Irritation was scored by the method of Draize.
The test item produced redness of the conjunctivae in all three animals as well as opacity of the comea in one animal. Effects were fully reversible.
No comeal lesions were found upon fluorescein examination at the final readings.
In this study TDI-Urone was found to be slightly irritating to the eyes of rabbits but not relevant for classification.
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