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EC number: 946-937-7 | CAS number: -
- 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
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- 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
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 August 2009 to 20 October 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China).
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Not specified
Test material
- Reference substance name:
- 2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate
- EC Number:
- 946-937-7
- Molecular formula:
- C36H62N2O8
- IUPAC Name:
- 2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate
- Test material form:
- liquid
- Details on test material:
- - Storage: cool and dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adults
- Acclimation period: 5 days prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24ºC
- Humidity: 50 to 70%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4 animals
- Details on study design:
- TREATMENT METHOD
- 0.1 g of the test material was applied to the conjunctival sac of right eye of each rabbit. The lids were then gently held together for about one second to prevent loss of the test material. No washing to eyes was taken for 24 hours after application.
OBSERVATIONS
- Eye irritation was evaluated at 1, 24, 48 and 72 hours after test material application. The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. Animals were observed daily for mortality and signs of morbidity. Survival animals were euthanatised after observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis scores were not measured
- Other effects:
- Individual eye irritation scores are presented in Table 1. No abnormal clinical signs were observed during the whole study period. No delayed damnification was observed for all animals. The highest mean eye irritation score in the first 4 days (mean of sum of the scores from cornea, iris and conjunctivae) was 2.5 and the score was 0 at 48 hours. All controls scored 0. Based on these results and the irritation grading criteria in the Guidelines for the Testing of Chemicals, the test article is light irritating to eye (the grade is 3).
Any other information on results incl. tables
Table 1: Eye irritation scores
Animal No. |
Position |
Eye Irritation scores |
|||||||
1 h |
24 h |
48 h |
72 h |
||||||
R |
L |
R |
L |
R |
L |
R |
L |
||
1 |
Conjunctivae |
2 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Conjunctivae |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Conjunctivae |
4 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Conjunctivae |
2 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total |
10 |
0 |
8 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
2.5 |
0.0 |
2.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Mean score (4 days) |
2.5, 0 (48 h) |
||||||||
Irritation |
Light irritation |
||||||||
Grade |
3 |
R = right eye, L = left eye
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this study, based on the Guidelines for the Testing of Chemicals the test material is light irritating to eye (the grade is 3).
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). 0.1 g of test material was administered into the conjunctival sac of right eye of four healthy rabbits with eye lids gently held together for about one second to prevent loss of the test material. The left eye was used as control for evaluation of eye irritation. No washing to eyes was taken for 24 hours after application. Eye irritation was evaluated at 1, 24, 48 and 72 hours after test material application. The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. Animals were observed daily for mortality and signs of morbidity; surviving animals were euthanatised after the observation period. Under the conditions of this study the highest mean eye irritation score in the first 4 days was 2.5 and the score was 0 at 48h. Based on the Guidelines for the Testing of Chemicals, the test material is 'lightly' irritating to the eye (the grade is 3).
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