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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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:
- 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- other: glittery semi-liquid
- Details on test material:
- Colour: orange
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- During the test, the animals (females) weighed between 1.93 kg and 2.56 kg. At the beginning of the test, the animals were 10-12 weeks old.
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23 °C and 30 to 70 %, respectively.
The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water and foodstuff were supplied freely.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated serving as control.
- Amount / concentration applied:
- 0.1 mL of the test item was instilled as supplied.
- Duration of treatment / exposure:
- 24 hours of exposure.
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed. - Number of animals or in vitro replicates:
- Three female albino New Zealand rabbits were treated sequentially.
After consideration of the responses produced on day 3 in the first animal, two additional animals were treated, in the same experimental conditions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;
- at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.
- at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3. - Other effects:
- None.
Any other information on results incl. tables
Animal No. | Time after treatment | CONJUNCTIVAE | IRIS | CORNEA | |
Chemosis (A) | Redness (C) | Lesion (D) | Opacity (E) | ||
1 | 24 hours | 0 | 2 | 0 | 0 |
48 hours | 0 | 1 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | |
Mean | 0.0 | 1.0 | 0.0 | 0.0 | |
2 | 24 hours | 1 | 2 | 1 | 2 |
48 hours | 1 | 2 | 0 | 2 | |
72 hours | 1 | 1 | 0 | 0 | |
Mean | 1.0 | 1.7 | 0.3 | 1.3 | |
3 | 24 hours | 2 | 2 | 0 | 2 |
48 hours | 1 | 2 | 0 | 0 | |
72 hours | 1 | 1 | 0 | 0 | |
Mean | 1.3 | 1.7 | 0.0 | 0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The test item C.A.E. Code: 8500010 was instilled as supplied into the eye of three New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established according to the OECD guideline No.405 dated April 24th, 2002 and the test method B.5 ohe council regulation No.440/2008.
The ocular reactions observed during the study have been slight to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;
- at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.
- at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified.No signal word or hazard statement is required.
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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