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EC number: 916-533-5 | 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:
- 20 December 2011 to 03 January 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts
- EC Number:
- 916-533-5
- Molecular formula:
- R-C6H6NO5Na2, R-C6H7NO5Na R: Coco fatty acid residue
- IUPAC Name:
- Reaction mass of l-Glutamic acid, N-coco acyl derivs., disodium salts and l-Glutamic acid, N-coco acyl derivs., monosodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White to pale yellow powder with a slightly characteristic odour.
- Storage condition of test material: room temperature (15-25 ºC) in the dark.
- pH: 6.5, determined by measurement of the supernatant from a 1% w/v mixture in distilled water.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Males
- Age at study initiation: Approximately 16 weeks old.
- Weight at study initiation: Ranged from 3615 to 3904 g
- Housing: Individually in metal wire cages.
- Diet: Commercial rabbit feed, ad libitum.
- Water: Municipal tap water, as libitum.
- Acclimation period: 41 days.
- 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.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C.
- Humidity (%): 28 to 67 %
- Air changes (per hr): 15 to 20 air charges per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day, from 06:00 to 18:00 hours.
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 - Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- 14 day
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- APPLICATION OF THE TEST MATERIAL
- An initial test was performed using one animal. The test material was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test material. The contralateral eye served as the control. Immediately after the administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1.
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.
All animals were sacrificed at the end of the observation period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was performed on test animals.
- Time after start of exposure: 1 hour.
OBSERVATIONS
- The eyes were examined at 1, 24, 48, 72 hours and 1 and 2 weeks after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.
- Any clinical signs of toxicity or signs of ill health during the study were recorded.
- Individual body weights were measured at the beginning and end of the observation period.
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002) shown in Table 2.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - Initial pain reaction: Slight initial pain was observed in all three animals, assigned a score of 2 (see Table 1).
- Control eye: The control eye of each animal was symptom-free.
- One hour after the application: conjunctival redness (score 2), discharge and chemosis (score 3) were seen in all rabbits. All animals showed corneal opacity (score 1, areas 2, 3 or 4).
- 24 hours after treatment: conjunctival redness (score 2), discharge (score 2 or 3) and chemosis (score 2) were seen in all rabbits. All animals showed corneal opacity (score 1 or 2, areas 1, 3 or 4).
- 48 hours after treatment, conjunctival redness (score 1 or 2), discharge (score 1 or 2) and chemosis (score 1) were seen in all rabbits. All animals showed corneal opacity (score 1, areas 1 or 3).
- 72 hours after treatment: conjunctival redness (score 1) was seen in all rabbits. Conjuctival discharge (score 1) and chemosis (score 1) were seen in two animals. All animals showed corneal opacity (score 1, areas 1 or 2).
- One week after treatment: conjunctival redness (score 1) was seen in two rabbits.
- Two weeks after treatment: no signs of eye irritation or other clinical signs were observed. The study was terminated after the 2-week observation as effects were fully reversible by this time. - Other effects:
- - Mortality: None observed during the study.
- Bodyweights: The body weight and body weight change were considered to be normal with no indication of treatment related effect. Final weights ranged from 3799 to 4088 g, representing a weight gain of between 181 and 187 g.
- Clinical observations: There were no clinical signs observed that could be related to treatment. The general state and behaviour of animals were normal throughout the study period.
Any other information on results incl. tables
Table 3: Individual Scores for Ocular Irritation at 1 hour
Animal No. |
Score of Irritation |
IPR |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
1 |
2 |
3 |
3 |
1 |
4 |
0 |
0 |
- |
2 |
2 |
2 |
3 |
3 |
1 |
3 |
0 |
0 |
- |
2 |
3 |
2 |
3 |
3 |
1 |
2 |
0 |
0 |
- |
2 |
Table 4: Individual Scores for Ocular Irritation at 24 hours
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
2 |
2 |
2 |
1 |
4 |
0 |
0 |
- |
2 |
2 |
2 |
2 |
1 |
3 |
0 |
0 |
- |
3 |
2 |
2 |
3 |
2 |
1 |
0 |
0 |
- |
Table 5: Individual Scores for Ocular Irritation at 48 hours
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
2 |
1 |
1 |
1 |
3 |
0 |
0 |
- |
2 |
1 |
1 |
2 |
1 |
3 |
0 |
0 |
- |
3 |
1 |
1 |
2 |
1 |
1 |
0 |
0 |
- |
Table 6: Individual Scores for Ocular Irritation at 72 hours
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
1 |
1 |
1 |
1 |
2 |
0 |
0 |
- |
2 |
1 |
1 |
0 |
1 |
2 |
0 |
0 |
- |
3 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
- |
Table 7: Individual Scores for Ocular Irritation at 1 week
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Table 8: Individual Scores for Ocular Irritation at 2 weeks
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
R = redness, CH = chemosis; D = discharge; OD = opacity degree of density; OE = extent of opaque area; IPR = initial pain reaction.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material was determined to be irritating to the eye based on corneal opacity. Application of the test material to the rabbit’s eye caused significant conjunctival and corneal effects at one hour, which were reduced at 1 week after application. All effects were fully reversible within 14 days.
- Executive summary:
The potential for the test material to cause eye irritation was assessed in an in vivo irritation study in rabbits. The study was performed under GLP conditions in line with standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400. The test material was administered to three male New Zealand white rabbits, in a single application which was washed after 1 hour. Rabbits were assessed over a 14 day observation period for signs of eye irritation, clinical sign of toxicity, mortality and bodyweight gain. Application of the test material to the rabbit’s eye caused significant conjunctival and corneal effects at one hour, which were reduced 1 week after application. The study was terminated after 14 day as all signs of irritation were fully reversed. Under the conditions of the study, the test material was determined to be an eye irritant (category 2).
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