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EC number: 700-798-7 | CAS number: 877399-00-3
- 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
Skin irritation/corrosion
Two studies are available:
1) A skin irritation study (Beerens - Heijnen, 2010) is available which is key study. This study showed that the test substance is not irritating.
2) An in vitro skin corrosion study (Buskens, 2010) is available which is supporting study. This study showed that the test substance is not corrosive.
Eye irritation
Two studies are available:
1) An acute eye irritation study (Beerens - Heijnen, 2010) is available which is key study. This study showed that the test substance is slightly irritating.
2) An in vitro BCOP study (Verspeek-Rip, 2010) is available which is supporting study. This study showed that the test substance is not irritating.
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
- Study period:
- From 24 August to 02 September 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: between 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: housed in labeled cages with perforated floors and shelters
- Diet (e.g. ad libitum): Pelleted diet approximately 100 grams per day, Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.0-19.9ºC)
- Humidity (%): 40-70% (actual range: 49 - 87%)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: 2010-08-24 To: 2010-09-02 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 150 square centimeters (10x15 cm)
- % coverage:
- Type of wrap if used: Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to the test substance.
- Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No skin irritation was caused by 4 hours exposure to the test substance.
Reference
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Animal |
476 |
479 |
480 |
|||
Time after exposure |
Erythema (0-4) |
Oedema (0-4) |
Erythema (0-4) |
Oedema (0-4) |
Erythema (0-4) |
Oedema (0-4) |
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
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
- Study period:
- From 02 to 24 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: between 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: labeled cages with perforated floors and shelters
- Diet (e.g. ad libitum): pelleted diet approximately 100 grams per day, hay was provided at least three times a week
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0±3.0℃ (actual range: 19.2-20.3℃)
- Humidity (%): 40-70% (actual range: 46-82%)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: 2010-08-02 To: 2010-08-24 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 98.3 mg (range 95.3-103.8 mg) (a volume of approximately 0.1 mL) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: fully reversible within 72 hours in two animals and within 7 days in the other animal
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: fully reversible within 48 hours in all of 3 animals
- Irritant / corrosive response data:
- Instillation of approximately 98 mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the other animal.
No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. - Other effects:
- Remnants of the test substance were present in the eye of two animals on Day 1.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Treatment of the test substance caused reversible effects on conjunctivae of all the three rabbits.
Reference
Animal |
Time after dosing
|
Cornea (0-4) |
Iris (0-2) |
Conjunctivae |
||
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
||||
462 |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
1 1 1 0 |
1 1 0 0 |
1 1 0 0 |
470 |
1 hour 24 hours 48 hours 72 hours 7 days |
0 0 0 0 0 |
0 0 0 0 0 |
1 2 1 1 0 |
1 1 0 0 0 |
1 1 0 0 0 |
471 |
1 hour 24 hours 48 hours 72 hours 7 days |
0 0 0 0 0 |
0 0 0 0 0 |
2 1 1 0 0 |
1 0 0 0 0 |
1 0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion
Two studies are available:
1) A primary skin irritation study was conducted according to OECD 404 using rabbits (Beerens - Heijnen, 2010). Key study.
This study showed that the test substance is not irritating.
2) An in vitro skin corrosion study was conducted according to OECD 431 using a human skin model (Buskens, 2010). Supporting study.
In the interest of animal welfare and to minimize any testing likely to produce severe responses in animals, a human skin model test was performed. This study showed that the test substance is not corrosive. Based on this, in vivo skin irritation study in rabbit was performed to establish the possible skin irritating properties of the test substance.
Eye irritation
Two studies are available:
1) An acute eye irritation study was conducted according to OECD 405 using rabbits (Beerens - Heijnen, 2010). Key study.
This study showed that the test substance is slightly irritating.
2) An in vitro BCOP study was conducted according to OECD 437 using bovine cornea (Verspeek-Rip, 2010). Supporting study.
In the interest of animal welfare and to minimize any testing likely to produce severe responses in animals, an in vitro BCOP test was performed. This study showed that the test substance is not irritating. Based on this, in vivo eye irritation study in rabbit was performed to establish the possible eye irritating properties of the test substance.
Justification for selection of skin irritation / corrosion endpoint:
Study run to a method comparable with current guidelines and to GLP
Justification for selection of eye irritation endpoint:
Study run to a method comparable with current guidelines and to GLP
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were < 2.3 (actual value 0) for oedema were < 2.3 (actual value 0). In addition all reactions were fully reversible within the observation period (actual value within 72 hours).
Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were < 1 (actual value 0), for iritis were < 1 (actual value 0), for conjunctival redness were < 2 (actual value 0.89) and for conjunctival oedema were < 1 (actual value 0.67).
Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.2.2 & 3.3.2 the substance is not classified for the skin corrosion/irritation and serious eye damage/eye irritation endpoint.
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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