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Diss Factsheets
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EC number: 468-740-0 | 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:
- 13 June 2005 to 05 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000); including most recent partial revisions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 3285
- IUPAC Name:
- MTDID 3285
- Details on test material:
- - Name of test material (as cited in study report: MTDID 3285
- Substance type: Light brown waxy chunks
- Physical state: solid
- Analytical purity: minimum 86%
- Lot/batch no.: Lot 30045
- Expiration date of the lot/batch: 01 June 2006
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Molecular weight: 610. pH (1% in water) 9.8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: Individual labeled cages with perforated floors
- Diet (e.g. ad libitum): ad libitum to a controlled amount (approx 100g/day)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 21.8 degrees C
- Humidity (%): 34-80% (optimal maximum humidity level is 70%, but these fluctuations were considered not to have affected study integrity).
- Air changes (per hr): approximately 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
IN-LIFE DATES: From: 13 June 2005 To: 11 July 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was ground to a powder using a mortar and pestle prior to weighing
- Controls:
- other: one eye was treated with the test article, the other eye served as a control
- Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): mean weight of 44.7 mg (a volume of approximately 0.1ml)
- Duration of treatment / exposure:
- treatment duration lasted for a few seconds during instillation of test article in the conjuctival sac of one eye. The test article remained in the eye for 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 7 days after instillation of test article
- Number of animals or in vitro replicates:
- 3 animals per sex per dose
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2% fluorescein in water (adjusted to pH 7.0 was instilled into both eyes of each animal to qantify corneal epithelial damage.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Numerical scoring system assessing corneal irritation, area of conrea involved, IRIS, conjunctival irritation, Chemosis and Discharge.
TOOL USED TO ASSESS SCORE: biomicroscope used to assess scores when standard lighted was inadequate, fluorescein used to assess corneal damage.
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Remarks:
- and irritation, corneal opacity, iris irritation
- Basis:
- other: draize scoring (0-4)
- Time point:
- other: 24, 48 and 72 hours and 7 days post exposure
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: No iridial irritation or corneal opacity were observed. No corneal epithelial damage was observed after treament of fluorescein. Conjunctival irritation consisted of redness, chemosis and discharge which reversed through 2 days.
- Irritant / corrosive response data:
- There was no evidence of ocular corrosion.
- Other effects:
- Scores of zero were noted at all time points for iris and corneal irritations. Scores of 2 were noted for conjunctival irritation through 72 hours.
Any other information on results incl. tables
Animal 1 (#680)
|
Cornea |
Iris |
Conjunctivae |
|
||||
Time after dosing |
Opacity (0-4) |
Area (0-4) |
Fluor area (%) |
(0-2) |
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
Comments |
1 hour |
0 |
0 |
|
0 |
1 |
1 |
1 |
Remnants of test substance in eye |
24 hours |
0 |
0 |
0 |
0 |
2 |
2 |
2 |
Remnants of test substance in eye |
48 hours |
0 |
0 |
|
0 |
2 |
1 |
1 |
|
72 hours |
0 |
0 |
|
0 |
2 |
0 |
0 |
|
7 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
Animal 2 (#698)
|
Cornea |
Iris |
Conjunctivae |
||||
Time after dosing |
Opacity (0-4) |
Area (0-4) |
Fluor area (%) |
(0-2) |
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
1 hour |
0 |
0 |
|
0 |
2 |
2 |
1 |
24 hours |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
48 hours |
0 |
0 |
|
0 |
1 |
1 |
0 |
72 hours |
0 |
0 |
|
0 |
1 |
0 |
0 |
7 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
Animal 3 (#700)
|
Cornea |
Iris |
Conjunctivae |
|
||||
Time after dosing |
Opacity (0-4) |
Area (0-4) |
Fluor area (%) |
(0-2) |
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
Comments |
1 hour |
0 |
0 |
|
0 |
2 |
2 |
1 |
Remnants of test substance in eye |
24 hours |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
|
48 hours |
0 |
0 |
|
0 |
1 |
0 |
0 |
|
72 hours |
0 |
0 |
|
0 |
1 |
0 |
0 |
|
7 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD GHS and EC criteria for classficiation and labelling of dangerous substances and preparations
- Conclusions:
- Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labelling requirements for dangerous substances and preparations.
- Executive summary:
The acute eye irritation/corrosion of the test article was assessed based on OECD 405, EC Council Directive 67/548/EEC, EPA OPPTS 870.2400 and JMAFF guidelines (2000). Single samples of approximately 45 mg of the test article (volume approx. 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days. Remnants of the test substance were present in the eye on day 1 and/or 2. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labelling requirements for dangerous substances and preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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