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EC number: 480-310-4 | 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
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- Endpoint summary
- Stability
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- 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
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- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- 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, other
- Remarks:
- An adequate in vivo study was conducted on the test article prior to the requirement for in vitro data.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 March 2007 to 02 May 2007 (In-life phase)
- 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:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Manual temp recording and no monitoring for humidity was done on 06 April 2007.It is expected the relative humidity remained within 30-70% based on data during time period from adjacent rooms. Study integrity not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: EC, Council Directive 67/548/EEC, An. V, B.5, (2004) "Acute Toxicity: Eye Irritation/Corrosion"
- Deviations:
- yes
- Remarks:
- Manual temp recording and no monitoring for humidity was done on 06 April 2007.It is expected the relative humidity remained within 30-70% based on data during time period from adjacent rooms. Study integrity not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"
- Deviations:
- yes
- Remarks:
- Manual temp recording and no monitoring for humidity was done on 06 April 2007.It is expected the relative humidity remained within 30-70% based on data during time period from adjacent rooms. Study integrity not adversely affected by the deviations.
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000); including the most recent partial revisions.
- Deviations:
- yes
- Remarks:
- Manual temp recording and no monitoring for humidity was done on 06 April 2007.It is expected the relative humidity remained within 30-70% based on data during time period from adjacent rooms. Study integrity not adversely affected by the deviations.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid (30% active ingredient in water)
- Details on test material:
- - Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colorless liquid
- Physical state: Liquid
- Analytical purity: 30% active ingredient in water
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-19/10
- Expiration date of the lot/batch: 01 December 2008
- Storage condition of test material: At room temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White, (SPF-Quality)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands.
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: Individually in labeled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (K-H from SSNIFF Spezialdiaten GmbH, Soest, Germany) approx. 100 g. per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days before start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8-22.9 degrees Celsius
- Humidity (%):31-66%
- Air changes (per hr): No Data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 March 2007 To: 02 May 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Second eye of animal remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance
- Concentration (if solution): 30% active ingredient in water - Duration of treatment / exposure:
- Test substance was instilled into one eye and observed for 21 days.
- Observation period (in vivo):
- Tested eye was observed for 21 days
- Number of animals or in vitro replicates:
- 3 males were tested
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Observations at 1, 24, 48, 72 hours, and days 7, 14, and 21.
- Score:
- ca. 0 - ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Individual eye irritation scores are below in Table 1.
- Irritant / corrosive response data:
- Corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75% of the corneal area in one animal and 50% in the other two animals). As a result of the corneal injury, in two animals pannus (neovascularisation of the cornea) was apparent 7 and 14 days after instillation. The corneal injury had resolved within 7 days in one animals and within 21 days in the other two animals. Iridial irriation grade 1 was observed and had resolved within 7 days in all animals. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 21 days in one animal and within 14 days in the other two animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, the test substance caused severe eye irritation which was fully reversible within 21 days. Based on these results the test substance should be classified as irritating to eyes (Category 2A according to GHS criteria and R36 according to EC criteria).
- Executive summary:
The purpose of this study was to assess the acute eye irritancy/corrosivity of the test substance in rabbits according to OECD Test Guideline 405. Single samples of 0.1 ml of the test substance were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (50-75% of the corneal area). As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent 7 and 14 days after instillation in two animals. The corneal injury had resolved within 7 days in one animal and within 21 days in the other two animals. lridial irritation grade 1 was observed and had resolved within 7 days in all animals. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 21 days in one animal and within 14 days in the other two animals. Under the conditions of the study, the test substance caused severe eye irritation which was fully reversible within 21 days. Based on these results the test substance should be classified as irritating to eyes (Category 2A according to GHS criteria and R36 according to EC criteria).
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