Registration Dossier
Registration Dossier
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EC number: 700-597-4 | CAS number: 1215841-86-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-06-03 to 20911-06-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; GLP study without deviation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
- EC Number:
- 700-597-4
- Cas Number:
- 1215841-86-3
- Molecular formula:
- C16H30N2O6
- IUPAC Name:
- (1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- CAS name: 1,4-Cyclohexanedicarboxamide, N1,N1,N4,N4-tetrakis(2-hydroxyethyl)-, trans
Chemical characterization: Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Characteristics: Whitish, solid, powder, hydroscopic
Contents:
91.53 % Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: male
- Age: approx. 5.5 to 6.5 monzhs
- Weight at study initiation: 1.7 kg up to 2.9 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- - Amount:
- Concentration: 100 mg - Duration of treatment / exposure:
- One hour after administration the eyes were rinsed with 20 mL 0.9% aqueous NaCl solution.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- ADMINISTRATION: The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: One hour after administration the eyes were rinsed with 20 mL 0.9% aqueous NaCl solution.
TOOL USED TO ASSESS SCORE: Ophthalmoscopic examination with a slit lamp:
prior to the administration and 1, 24, 48 and 72 hours after administration; 24 hours after administration, the eyes were treated additionally
with fluorescein and examined.
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0
- Conjunctivae (Chemosis): 0 - Other effects:
- no other effects
Any other information on results incl. tables
Acute eye irritation/corrosion test of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide
in rabbits
Examination of the treated eye
Time after administration |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
|
|
Opacity |
|
Redness# |
Chemosis## |
|
A n i m a l n o. : 1 / 2 / 3 |
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right eye: 100 mg test item |
||||
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|
before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
|
|
|
|
1 hour |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
|
|
|
|
|
24 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
|
|
|
|
48 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
|
|
|
|
72 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was n o n - i r r i t a t i n g to eyes, hence, no labelling is required.
- Executive summary:
The purpose of this study was to obtain information on the influence of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide on rabbit eyes (irritation/corrosion test),
according to OECD guideline 405, EC method B.5. and OCSPP guideline 870.2400.
Under the present test conditions a single administration of the test item per animal into the conjunctival sac of the right eye of three rabbits caused following effect:
Conjunctival redness (grade 1) was observed in all animals only 1 hour after instillation.The effect was reversible within 24 hours.
The corneae and irises were not affected by instillation of the test item. There were no systemic intolerance reactions.Therefore, according to the EC Regulatiom 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is non-irritating to eyes, hence, no labelling is required.
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