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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
Endpoint summary
Administrative data
Description of key information
Skin:
The skin irritation study is performed using rabbits, according to OECD Guideline 404 under GLP. The
substance is not irritating to rabbit skin.
Eye:
The eye irritation study is performed using rabbit eyes, according to OECD Guideline 405 under GLP.
The substance is slightly irritant to rabbit eyes. While based on GHS, it is not classified as eye irritant.
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)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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, on 02 Nov 2016.
- Age at study initiation: The male animal was born on either 09 Jul2016 or 16 Jul2016 and the
female animals were born on 16 Ju12016.
- Weight at study initiation: The pre-test body weight range was 3.1 -3.3 kg .
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and
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): temperature controlled
- 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:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g per site and moistened with 0.6 ml of distilled water
- 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: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used: 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 f
ollowing 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 (fourhour
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. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- Systemic Observations: No abnormal physical signs were observed.
Body Weights: All three animals' weights remained the same by study termination. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to rabbit skin.
- Executive summary:
The skin irritation study is performed using rabbits, according to OECD Guideline 404 under GLP. The
substance 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 19 Dec 2016
- 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
- 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, on 02 Nov 2016
- Age at study initiation: The male animals were born on 09 Jul2016 and/or 16 Jul2016 and the female
animal was born on 16 Ju12016.
- Weight at study initiation: The pre-test body weight range was 3.0 -3.2 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper b
edding 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): temperature controlled
- 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:
- 0.1 ml equivalent (59 mg)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 14 days
- 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- 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 term
ination. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is slightly irritant to rabbit eyes.
- Executive summary:
The eye irritation study is performed using rabbit eyes, according to OECD Guideline 405 under GLP.
The substance is slightly irritant to rabbit eyes. While based on GHS, it is not classified as eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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, key study, OECD 404:
Mean score for erythema at 24, 48, 72 h for 3 tested animal: 0, 0, 0
Mean score for edema at 24, 48, 72 h for 3 tested animal: 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, key study, OECD 405:
Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:
cornea opacity: 0, 0, 0;
iris: 0.33, 0.33, 0;
conjunctivae: 1, 1, 0.33;
chemosis: 1, 0.33, 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.
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