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EC number: 258-981-8 | CAS number: 54112-23-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
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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 September 20, 2012 to December 3, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- Grilbond IL-6
- IUPAC Name:
- Grilbond IL-6
- Reference substance name:
- N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]
- EC Number:
- 258-981-8
- EC Name:
- N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]
- Cas Number:
- 54112-23-1
- Molecular formula:
- C27H32N4O4
- IUPAC Name:
- 2-oxo-N-[4-({4-[(2-oxoazepane-1-carbonyl)amino]phenyl}methyl)phenyl]azepane-1-carboxamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- EC no.: 258-981-8
Purity: 99%
Batch/Lot Number: 9114761/024
Production Date: 12 July 2012
Expiry Date: 11 July 2013
Molecular formula: C27H32N4O4
Chemical name: N,N’-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]
Storage conditions: Room temperature
Safety Precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
Justification of strain: The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined prior to starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 3 animals
Age of animals at treatment: ~11 weeks old (adult)
Sex: Male
Body weight range at the beginning of the life phase: 2704 – 2763 g
end of the life phase: 2788 – 2852 g
Date of receipt: 19 September 2012
Acclimatization time: at least 5 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.
HUSBANDRY
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 609
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 20 ±3 °C
Relative humidity during the study: 44 – 80%
Housing/Enrichment: 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
Ventilation: 15 - 20 air exchanges/hour
The environmental parameters were recorded twice daily during the study. Variations from the target relative humidity (max. 80%) were observed during the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye served as control
- Amount / concentration applied:
- Dosage: A single amount of 0.1 g of the solid test item Grilbond IL-6 100% was administered to each animal.
Application of the Test Item: Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected.
An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contra lateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated. - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- Clinical Observations: The eyes were examined at 1, 24, 48 and 72 hours after treatment.
Scoring and Assessment of Local Reaction: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002). - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The treated eye was rinsed with physiological saline solution at the 1-hour observation.
Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24-72hours
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR) (score 1) was observed in all animals.
One hour after the application, conjunctival redness (score 1) was seen in all animals, discharge (score 1 or 2) was observed in two rabbits and chemosis (score 1) was seen in one rabbit.
At 24, 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed.
As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation. - Other effects:
- MORTALITY
There was no mortality observed during the study.
BODY WEIGHTS
The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
CLINICAL OBSERVATION
General daily examination:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, test article can not be considered to be a eye irritant.
- Executive summary:
This acute eye irritation study was performed to investigate the primary eye irritation potential of test article in New Zealand White rabbits. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose. Initial Pain Reaction (IPR) (score 1) was observed in all animals. One hour after the application, conjunctival redness (score 1) was seen in all animals, discharge (score 1 or 2) was observed in two rabbits and chemosis (score 1) was seen in one rabbit. At 24, 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed. As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
Therefore, test article is not considered as an irritant to rabbits' eyes under the experimental conditions.
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