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EC number: 610-945-6 | CAS number: 53037-34-6
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 11 May 2016 to 17 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- Oligomerisation reaction products of glyoxal and urea.
- EC Number:
- 610-945-6
- Cas Number:
- 53037-34-6
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Oligomerisation reaction products of glyoxal and urea.
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: provided by Sponsor
- Expiration date of the lot/batch: 15 March 2017
- Purity: 45.4% active ingredient in water solution
- Colour: light yellow
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator (2-8°C).
The substance is deemed to be stable.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Preliminary purification step (if any): Water solution provided by Sponsor was Freeze-dried to produce the dry Test Item used in this study. Considered as 100%
FORM AS APPLIED IN THE TEST: the dry Test Item was used in the study (solid)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary- Age at study initiation: 14 weeks old (male young adult)- Weight at study initiation: 3222 g – 3929 g- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.- Diet: ad libitum- Water: ad libitum- Acclimation period: at least 28 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20.0 – 24.0°C- Humidity (%): 28 – 68 %- Air changes (per hr): 15-20 air exchanges/hour- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.IN-LIFE DATES: From: 11 May 2016 To: 14 May 2016
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 of test item
- Duration of treatment / exposure:
- The test substance was placed in the conjunctival sac. The treated eye of test animals was not rinsed with physiological saline solution, test item remained in the eye sac at the one hour observation time point
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE - Washing (if done): no washing was conducted. SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012) TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 48 hours.
- Other effects:
- - Lesions and clinical observations:No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period.Animal 1 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.Animal 2 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.Animal 3 clinical observations:At one hour after the application, conjunctival redness (score 1), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item did not remain in the eye sac.At 24 hours after the application, conjunctival redness (score 1) was noted in the rabbit.At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.- Other observations: The general state and behaviour of animals were normal throughout the study period. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
INDIVIDUAL SCORES FOR OCULAR IRRITATION
Animal Number | Sex | Cornea Opacity | Iris | Conjunctivae | ||
Redness | Chemosis | Discharge | ||||
811 | male | 0.00 | 0.00 | 0.33 | 0.00 | 0.00 |
813 | male | 0.00 | 0.00 | 0.33 | 0.00 | 0.00 |
828 | male | 0.00 | 0.00 | 0.33 | 0.00 | 0.00 |
Animal 1
Time | Score of irritation | IPR/ PR | Other sign | |||||||
Conjunctivae | Cornea | Iris |
| |||||||
R | CH | D | OD | OE | R | |||||
Pre- treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Post-treatment | 1 h | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
24 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 2
Time | Score of irritation | IPR/ PR | Other sign | |||||||
Conjunctivae | Cornea | Iris |
| |||||||
R | CH | D | OD | OE | R | |||||
Pre- treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Post-treatment | 1 h | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
24 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 3
Time | Score of irritation | IPR/ PR | Other sign | |||||||
Conjunctivae | Cornea | Iris |
| |||||||
R | CH | D | OD | OE | R | |||||
Pre- treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Post-treatment | 1 h | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
24 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Abbreviations: R = Redness OD = Opacity degree of density
CH = Chemosis OE = Extent of opaque area
D = Discharge IPR/PR = Initial or any pain reaction
0 = Normal (in case of control eye and other lesions)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions, the test item does not require classification as an eye irritant.
- Executive summary:
The eye irritation potential of the test item was determined in accordance with the OECD Nº 405 with GLP. The test item was applied on three New Zealand male White rabbits (0.1g/eye). Animals were observed at 1h, 24h, 48 and 72h after the test item was applied. The corneal opacity score, the iris score and the conjunctive score (Discharge, Redness and Chemosis) were evaluated. No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period. The test item, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 48 hours.The mean chemosis score, mean discharge score, mean cornea score and mean iris score were all 0.0, whereas the mean redness score was 0.33.According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, the test item does not require classification as an eye irritant.
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