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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
SKin irritation:
The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item is not irritating to rabbit skin.
Eye irritation:
The study is performed according to OECD Guideline 405. It is concluded that the test item is not irritating to rabbit eyes.
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 06 Dec 2016 to 09 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: The male animal was born on 11 Jun 2016 and the female animals were born on 04 Jun 2016.
- Weight at study initiation: The pre-test body weight range was 3.2 -3.5 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g per site and moistened with 0.4 ml of distilled water to form a pasty consistency.
- Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours
- Observation period:
- 72 hours
- Number of animals:
- one male, two females
- Details on study design:
- TEST SITE
- Area of exposure: The test article was applied over a 2 x 3 cm gauze patch.
- % coverage:
- Type of wrap if used: Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The dose patch was secured with non-irritating tape and the rabbit was gently held in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water following patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Exposure Site 1 of the initial animal was scored for dermal irritation immediately post-exposure and at one hour post-exposure. Sites 2 (one-hour exposure) and 3 (four-hour exposure) were scored for dermal irritation at 1, 24, 48 and 72 hours hours after patch removal.
SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- Systemic Observations: No abnormal physical signs were observed.
Body Weights: One animal gained weight and two animals' weights remained the same by study termination. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to rabbit skin.
- Executive summary:
The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item is not irritating to rabbit skin.
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
- Study period:
- From 05 Dec 2016 to 16 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA
- Age at study initiation: The male animals were born on 27 Aug 2016 and the female animal was born on 20 Aug 2016.
- Weight at study initiation: The pre-test body weight range was 2.4 - 2.7 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml equivalent (60 mg) - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- two males, one female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique.
TOOL USED TO ASSESS SCORE: Sodium fluorescein dye procedures were performed at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- Systemic observations: No abnormal physical signs were observed.
Body Weights: Two animals gained weight and one animal's weight remained the same by study termination. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to rabbit eyes.
- Executive summary:
The study is performed according to OECD Guideline 405. It is concluded that the test item is not irritating to rabbit eyes.
Reference
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
Skin irritation / corrosion:
In vivo skin irritation, OECD 404:
Mean score for erythema at 24, 48, 72 h for 3 tested animals: 0, 0, 0
Mean score for edema at 24, 48, 72 h for 3 tested animals: 0, 0, 0
According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.
Eye irritation:
In vivo eye irritation, OECD 405:
Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:
cornea opacity: 0, 0, 0;
iris: 0, 0, 0;
conjunctivae: 0.67, 0.67, 0.67;
chemosis: 0, 0, 0.
According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for this 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.
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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