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Diss Factsheets
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EC number: 238-874-2 | CAS number: 14806-72-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1996-06-28 to 1996-08-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart E, Specific Organ/Tissue Toxicity, Primary Eye Irritation, 798.4500
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Self Certified
Test material
- Reference substance name:
- -
- EC Number:
- 427-360-5
- EC Name:
- -
- IUPAC Name:
- 427-360-5
- Details on test material:
- Description: Light Yellow Solid
Stability of test compound: Stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Number 6
Sex Male and female
Age: 10 – 12 weeks old
Weight at dosing: Between 2.0 and 3.0 kilograms
Source: Purchased from a registered commercial breeder
Acclimatisation period: Minimum 5 days under the same conditions as for the acute test.
Diet: Commercial rabbit ration, ad libium
Water: Tap water, ad libium
Housing: Individually housed
Environmental conditions -
Temperature: 63 - 73°F
Humidity 30-70%
Air changes: 10 to 15
Photoperiod: 12-hour light/dark cycle, full spectrum fluorescent lights.
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of the test substance was instilled into the left eye of each animal
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out for 24 hours following instilation of the test substance. After the 24 hour reading, all eyes were washed with 0.9% Sodium Chloride for Infection USP.
- Observation period (in vivo):
- Eyes were examined at 1, 24, 48 and 72 hours post treatment, using the Draize scale. Since there was no irritation at 72 hours, the study was discontinued.
- Number of animals or in vitro replicates:
- Six animals were tested.
- Details on study design:
- The left eye of each animal was treated with a single dose of the test substance. The right eye remained untreated and thus served as a control.
Eyes were examined at 1, 24, 48, and 72 hours post-treatment, using the Draize scale. Since there wsa no irritation at 72 hours, the study was discontinued. Fluorescein staing was use during each examination, exluding the 1 hour exam. The examinations were facilitated by the use of a slit-lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No overt signs of toxicity were evident during the course of the study in any animals. No TSCA positive reactions for eye irritation were observed in any of the test or control animals at any of the observation points. Blistering of the nictitating membrane was observed in 2/6 animals at the 1 hour and 24 hour points. no fluorescein staining was evident in any of the test animals prior to treatment or at 24, 48 or 72 hours following treatment. There were no animals with positive TSCA scores for ocular irritation.
- Other effects:
- All animals exhibited an increase in body weight during the course of the study.
Any other information on results incl. tables
Table I: Lesion summary sheet (treated eye).
Lesion |
Number of positive responses/Total number of test eyes |
|||
1 hour |
24 hour |
48 hour |
72 hour |
|
Cornea |
||||
Opacity |
0/6 |
0/6 |
0/6 |
0/6 |
Iris |
||||
Conjunctiva |
0/6 |
0/6 |
0/6 |
0/6 |
Redness |
||||
Chemosis |
0/6 |
0/6 |
0/6 |
0/6 |
Table II: Body weights and clinical observations, summary of clinical observations on Day 0 through Day 3.
|
|
Body Weight (Kg) |
|
||
Animal # |
Sex |
Day 0 |
Day 3 |
Weight Change |
Signs of Toxicity* |
60905 |
Male |
2.36 |
2.41 |
0.05 |
None |
60906 |
Female |
2.27 |
2.31 |
0.04 |
None |
60907 |
Male |
2.39 |
2.43 |
0.04 |
None |
60908 |
Female |
2.24 |
2.29 |
0.05 |
None |
60909 |
Male |
2.41 |
2.46 |
0.05 |
None |
60910 |
Female |
2.31 |
2.37 |
0.06 |
None |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of this study, the test substance, RA2, is not considered an eye irritant to the ocular tissue of albino rabbits.
- Executive summary:
The test substance was evaluated for its potential to produce an irritating effect on the ocular tissue of New Zealand White rabbits. The test susbtance was administered according to the procedures detailed in the study protocol.
No TSCA positive reations for eye irritation were observed in any test or control animals at any of the observation periods. Blistering of the nicitating membrane was observed in 2/6 animals at the 1 hour and 24 hour timepoints. In addition, no overt signs of toxicity were evident following treatment with the test substance and all of the animals exhibited an increase in body weight during the course of the study.
Based on the results of this study, the test substance, RA2, is not considered an eye irritant to the ocular tissue of albino rabbits.
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