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EC number: 272-902-4 | CAS number: 68919-76-6
- 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, other
- Remarks:
- in vivo test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-05 to 2012-11-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guideline 405 and EU method B.5 in a GLP-certified testing facility.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Test material form:
- other: liquid
- Details on test material:
- Sponsor' s identification: 400112
Date received: 24 September 2012
Container: brown glass flask (n=l)
Quantity: 93.15 g (container + contents)
Batch No: 0001273679
Colour: yellow-brown
Storage: room temperature
Production date: May 2011
Expiry date: May 2013
Purity: 100% (not purified but used as synthesized)
Composition: UVCB substance
It was identified under the code number: PH-12/0481
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One male albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste -F40260 Linxe).
Acclimatisation period: minimal 5-days
Age at the beginning of the test: 14 weeks
Body weight during the test: between 2.89 kg and 3.12 kg.
The animal was identified prior to inclusion in the test by means of a numbered ring on the edge of
one ear.
Housing: individual box installed in conventional air conditioned animal husbanding:
Temperature: 17 to 23°C
Relative humidity: 30 to 70%
Rate of air exchange: approximately between 10-15 changes per hour
Lighting: 12 h continuous light (07.00 to 19.00) and 12 h darkness.
Drinking water (tap-water from public distribution system) and foodstuff (SAFE- 112) were supplied freely.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of of the animal remained untreated serving as control
- Amount / concentration applied:
- 0.1 mL of test item was used, as supplied.
- Duration of treatment / exposure:
- 3 days
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 3.7
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 2
- Remarks on result:
- other: examination of "redness"
- Irritation parameter:
- iris score
- Remarks on result:
- other: The iris was not visible between day 0 (1 hour after instillation) and day 3.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 4
- Max. score:
- 4
- Other effects:
- White secretions requiring a physiological rinse was noted on days 2 and 3.
A brown coloration of the nictitating membrane was noted 1 hour after the test item application.
For ethical reasons, the animal was euthanized on day 3.
Any other information on results incl. tables
Animal n° |
Time aftertreatment |
CONJUNCTIVAE |
IRIS |
CORNEA |
|
CHEMOSIS |
REDNESS |
LESION |
OPACITY |
||
A2405 |
24h |
3 |
2 |
|
4 |
48h |
4 |
2 |
|
4 |
|
72h |
4 |
2 |
|
4 |
|
TOTAL |
11 |
6 |
|
12 |
|
Mean |
3.7 |
2.0 |
|
4.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1, causes serious eye damage according to EU regulation
- Conclusions:
- Based on the results of this in vivo test the test item 400112 must be classified according to Regulation (EC) No. 1272/2008 in category 1 "serious eye damage".
- Executive summary:
The test item 400112 was instilled as supplied, into the eye of one New Zealand rabbit at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 405 dated April 24th, 2002 and the test method B.5 of the council regulation No. 440/2008.
The ocular reactions observed during the study have been moderate to severe and were not reversible.
For ethical reasons, the animal was euthanized on day 3.
In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 "causes serious eye damage".
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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