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Diss Factsheets
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EC number: 912-666-8 | 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:
- 05 December 2005 to 15 December 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were individually housed in suspended cages
- Diet: free access
- Water: free access
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes 15 times per hour
- Photoperiod: 12 h darkness / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.06 ml of the test material (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after the treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating t the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+B+C) x 2
Score of iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC (1962) was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.
If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Individual Total Scores
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- overall irritation score
- Remarks:
- Individual Total Scores
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Remarks:
- Individual Total Scores
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Remarks:
- Individual Total Scores
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 110
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
No evidence of ocular irritation was noted in two treated eyes throughout the study or in the remaining treated eye at the 24-hour observation.
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation
Rabbit Number and Sex | 23 Male | 90 Male | 92 Male | |||||||||
IPR=2 | IPR=2 | IPR=2 | ||||||||||
Time After Treatment | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours |
CORNEA E = Degree of Opacity F= Area of Cornea Involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE A = Redness B= Chemosis C= Discharge |
1 0 1 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0sf |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0sf |
0 0 0 |
0 0 0 |
0 0 0 |
Score (A+ B + C) x 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Total Score | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IPR=Initial pain reaction
SF=Black staining of the fur around the treated eye
Individual total scores and group mean scores for ocular irritation
Rabbit Numer and Sex | Individual Total Scores At: | |||
1 Hour | 24 Hours | 48 Hours | 72 Hours | |
23 Male | 4 | 0 | 0 | 0 |
90 Male | 0 | 0 | 0 | 0 |
92 Male | 0 | 0 | 0 | 0 |
Group Total | 4 | 0 | 0 | 0 |
Group Mean Score | 1.3 | 0.0 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a maximum group mean score of 1.3 and was classified as practically non-irritant (class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the Guideline OECD 405 and Method B5.
A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. No evidence of ocular irritation was noted in two treated eyes throughout the study or in the remaining treated eye at the 24 -hour observation.
The test material produced a maximum group mean score of 1.3 and was classified as practically non-irritant (class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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