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EC number: 419-800-1 | 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
Endpoint summary
Administrative data
Description of key information
Reliable OECD guideline studies 404/405 are available for the test substance assessing the potential for skin and eye irritation. Both studies were conducted in accordance with GLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:NZW/Kbl(BR)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Manston.
- Age at study initiation: Fourteen to sixteen weeks old
- Weight at study initiation: 2.7 to 2.94 Kg
- Housing: Single floow pens with a minimum area of 0.6 sq m.
- Diet (e.g. ad libitum): SQC standard rabbit diet (pelleted) was freely available at all times.
- Water (e.g. ad libitum): Mains water provided ad libitum via water bottles.
- Acclimation period: At least 1 month
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22°C
- Humidity (%): 40 to 80%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): Twelve hours light/dark cycle
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg spread uniformly over the designated area. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Not less than 3 days
- Number of animals:
- 3 males (1 sentinel followed by 2 additional animals)
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm
- Type of wrap if used: Area covered by a dense gauze patch which in trun was covered by a larger gauze patch and an open weave elasticated adhesive bandage firmly wrapped around the torso.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated areas of the skin were swabbed with moist cotton wool.
- Time after start of exposure: Straight away after the 4 hour exposure period.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
- Method of calculation: Standard as per OECD guidelines. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no dermal changes or irritation reactions at sites of application of the test substance.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occluded application of the test substance to intact rabbit skin for 4 hours did not elicit any dermal changes or irritation reactions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:NZW/Kbl(BR)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd.
- Age at study initiation: Sixteen to nineteen weeks old
- Weight at study initiation: 3.16 to 3.57 Kg
- Housing: Single floor pens accomodating 1 rabbit with a minium floor area of 0.6 sq m.
- Diet (e.g. ad libitum): SQC standard rabbit diet (pelleted) was freely available at all times.
- Water (e.g. ad libitum): Mains water was provided ad libitum.
- Acclimation period: At least 1 month.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22°C
- Humidity (%): 40 to 80% RH
- Air changes (per hr): At least 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Vehicle:
- water
- Remarks:
- Dispersed in distilled water
- Controls:
- not required
- Amount / concentration applied:
- The test article was dispersed in distilled water and the pH of the 50% preparation was confirmed not to exceed 11.5 or to be less than 2 before dosing commenced. The test article was administered as a known weight (67 mg) with a compacted volume of 0.1 mL. Doses were expressed in terms of test article received and all doses were used on the day or preparation.
- Duration of treatment / exposure:
- A singular ocular instillation
- Observation period (in vivo):
- Not less than 3 days
- Number of animals or in vitro replicates:
- 3 rabbits (one sentinel followed by a further two exposures)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not performed
SCORING SYSTEM:
Standard as per OECD 405 guideline. The 'initial sting' response was assessed and recorded immediately after instillation of the test article. Treated animals were inspected for indications of distress or unacceptable ocular changes frequently during Day 1 (the day of dosing) and at least daily until completion of the observation period. Ocular changes were assessed and recorded immediately after treatment, one half hour, one and four hours after treatment on Day 1, and 24, 48 and 72 hours after treatment.
TOOL USED TO ASSESS SCORE: The treated eyes were examined visually or with the aid of a pencil-beam torch, biomicroscope or other device to illuminate or magnify the eye during examination. At examinations carried out 24 hours after treatment the cornea was subject to application of 2% aqueous fluorescein solution followed by irrigation with water for irrigation and illumination by an ultraviolet source. This facilitated detection of damage to the corneal epithelium as indicated by absorption of the fluorescing dye into the epithelium or stroma. The application of fluorescein was repeated in two rabbits 48 hours after treatment. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of the substance caused practically no initial sting response or a slight initial sting response. All rabbits developed a crimson-red appearance of the conjunctivae shortly after treatment. This was associated with slight chemosis in two rabbits and with a slight ocular discharge in one of the same animals. No conjunctival reactions of greater intensity developed later in the study but resolution of conjunctival irritation remained incomplete until three days after treatment.
The cornea of one rabbit showed an area (approximately 2 x 5 mm) of slight opacity that was also permeable to applied fluorescein on the day after ocular instillation of the test article. This corneal change resolved within two days of treatment. The iris remained overtly unaffected by the test substance. - Other effects:
- No observations indicative of systemic toxicity or ill health were noted for any rabbits during the course of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single instillation of the test substance to the conjunctival sac of three rabbits caused reversible changes of the conjunctivae in all animals and a transient and minor opacity of the cornea of one animal. However, the effects observed did not merit classification under UN GHS or the CLP Regulation (EC No. 1272/2008).
Reference
Group mean values for ocular reactions
Time of observation |
Ocular reaction |
|||
Corneal opacity |
Iris |
Conjunctival redness |
Chemosis |
|
1 hour |
0 |
0 |
1 |
0 |
4 hour |
0 |
0 |
1.3 |
0.7 |
24 hour |
0.3 |
0 |
0.7 |
0.3 |
48 hour |
0 |
0 |
0.7 |
0.3 |
72 hour |
0 |
0 |
0 |
0 |
Mean of 24, 48, and 72 hour scores |
0.1 |
0 |
0.4 |
0.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No skin effects or signs of irritation were observed in the available in vivo skin irritation study and accordingly the criteria for classification under the CLP Regulation (EC 1272/2008, as amended) is not met. Similarly effects were observed in the available in vivo eye irritation study did not met the CLP classification criteria based on the mean values at 24, 48 and 72 hours.
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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