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EC number: 245-524-2 | CAS number: 23251-72-1
- 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
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-08-17 to 1999-08-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 2000
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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- RA1
- IUPAC Name:
- RA1
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Liquid
- Stability under test conditions: Maximum 365 days
- Storage condition of test material: At room temperature at about 20 ºC, away from direct sunlight
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes,
F-01400 Chatillon sur Charlaronne,
France.
- Age at study initiation: Males: 15 weeks
Females: 14 weeks
- Weight at study initiation: Male 1 = 2737 g, Female 1 = 2917 g, Female 2 = 2974 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 50-80%
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: 17th August 1999 To: 30th August 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/animal
- Duration of treatment / exposure:
- The test substance was applied once into one eye of each rabbit. The treated eyes were not rinsed after application. Scoring of irritation effects was performed up to 7 days after test substance application.
- Observation period (in vivo):
- There was a 7 day observation period after the application of the substance.
- Number of animals or in vitro replicates:
- Three animals: One male and two females.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed following application
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after administration.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hour, and 7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour to 7 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 13
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Irritation:
Application of the test article to healthy rabbit conjunctiva resulted in a primary irritation score of 0.33 (out of 13). Slight reddening and slight swelling of the conjunctiva was noted in all animals one hour after treatment. Slight reddening of the conjunctiva persisted 72 hours after the administration in one animal and disappeared on the 7-day reading. The sclera of one animal was slightly reddened at the 1-hour examination.
Corrosion:
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- Viability/Mortality and Clinical Signs:
No clinical signs of systemic toxicity were observed in the animlas during the test and observation period, and no mortality occurred.
Coloration:
No staining by the test article was observed.
Body Weights:
The body weight of all rabbits were considered to be within the normal range of variability for the species.
Any other information on results incl. tables
Table 1: Body Weights:
Body Weights in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
1 |
Male |
2737 |
2903 |
3118 |
2 |
Female |
2917 |
3107 |
3291 |
3 |
Female |
2974 |
2840 |
3095 |
Table 2: Eye Irritation Scores - Individual Values:
Animal Number |
Sex |
Evaluation Interval |
Corneal Opacity |
Iris |
Conjunctivae |
Cumulative |
||
Redness |
Chemosis |
Score |
Mean |
|||||
1 2 3 |
Male Female Female |
1 hour |
0 0 0 |
0 0 0 |
1 1 1 |
1 1 1 |
2.00 2.00 2.00 |
2.00 |
1 2 3 |
Male Female Female |
24 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
48 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
72 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
7 days |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.00 0.00 0.00 |
0.00 |
Table 3: Eye Irritation Scores - Mean Values after 24, 48 and 72 hours:
Animal Number |
Sex |
Corneal Opacity |
Iris |
Conjunctivae |
Primary Eye Irritation Score |
|
Redness |
Chemosis |
|||||
1 2 3 |
Male Female Female |
0.00 0.00 0.00 |
0.00 0.00 0.00 |
0.00 1.00 0.00 |
0.00 0.00 0.00 |
0.33 |
Table 4: Eye Irritation Scores - Mean Values over Time:
Evaluation Interval |
Corneal Opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
1 hour |
0.00 |
0.00 |
1.00 |
1.00 |
24 hours |
0.00 |
0.00 |
0.33 |
0.00 |
48 hours |
0.00 |
0.00 |
0.33 |
0.00 |
72 hours |
0.00 |
0.00 |
0.33 |
0.00 |
7 days |
0.00 |
0.00 |
0.00 |
0.00 |
Table 5: Eye Irritation Scores - Assessment according to EC Guidelines:
Evaluated Interval |
Corneal Opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
24 hours 48 hours 72 hours |
Not Irritating |
Not Irritating |
Not Irritating |
Not Irritating |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP guideline study, RA1 was considered to be not irritating to the rabbit eye.
- Executive summary:
RA1 was tested for its eye irritation potential. 0.1 ml of the undiluted test substance was placed in the conjunctival sac of the left eye of each animal. The lids were gently held together for about 1 second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
Application of the test article to healthy rabbit conjunctiva resulted in a primary irritation score of 0.33 (out of 13). Slight reddening and slight swelling of the conjunctiva was noted in all animals one hour after treatment. Slight reddening of the conjunctiva persisted 72 hours after the administration in one animal and disappeared on the 7-day reading. The sclera of one animal was slightly reddened at the 1-hour examination.
No corrosion of the cornea was observed at any of the reading times. The test substance had no effect on viability, clinical signs or body weight.
Based on these results, RA1 is considered not to be an eye irritant.
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