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EC number: 944-482-9 | 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 irritation (OECD TG 404): Not irritating.
Eye irritation (OECD TG 405): Not irritating.
Respiratory irritation (based on absence human data and of irritation for skin and eye): no adverse effects observed. .
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:
- June 14, 1999 - June 17, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 3034g; females: 2447 and 2861g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.
ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 1 male
2 females - Details on study design:
- TEST SITE
Approximately three days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm^2 (10 cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.
TREATMENT
On the day of treatment, the test substance was applied approximately 6 cm^2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the guidelines. If evident, corrosive or staining properties of the test substance were described and recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2 and #3 (females)
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2 and #3 (females)
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.
- Other effects:
- No staining by the test substance of the treated skin was observed.
- Interpretation of results:
- other: Not classified.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its updates
- Conclusions:
- In a skin irritation study with 3 rabbits, performed according to OECD 404 guideline and GLP principles, very slight erythema and very slight oedema was observed in one male. All signs of irritation were fully reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed. The substance also does not need to be classified according to GHS.
- Executive summary:
The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.
In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Based on the results, the substance does not need to be classified for skin irritation/skin corrosion according to Regulation (EC) No. 1272/2008 and GHS.
Reference
The body weights of all rabbits were considered to be within the normal range of variability.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
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:
- June 21, 1999 - June 24, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 2613g; females: 2726 and 2581g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.
ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- TREATMENT:
The test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test substance.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the guidelines at approximately 1, 24, 48 and 72 hours after administration. When present, corrosion of and/or staining of sclera and cornea by the test substance were recorded and reported.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp. - Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.
- Other effects:
- The body weights of all rabbits were considered to be within the normal range of variability.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. - Interpretation of results:
- other: Not classified.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its updates.
- Conclusions:
- In an eye irritation study with 3 rabbits, performed according to OECD 405 guideline and GLP principles, slight irritation was observed. All signs of irritation were reversible within 24 hours. The substance does also not need to be classified according to GHS
- Executive summary:
The substance was tested for 4 hours in an eye irritation test in 3 rabbits according to OECD TG 405 test guideline and GLP principles.
In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Based on the results, the substance does not need to be classified for eye irritation according to Regulation (EC) No. 1272/2008 and its updates.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.
In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Eye irritation:
The substance was tested for 4 hours in an eye irritation test in 3 rabbits according to OECD TG 405 test guideline and GLP principles.
In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.
Respiratory irritation: For assessing respiratory irritation human data are key for assessing this endpoint. Animal data may be used to indicate effects (ECHA guidance, R7.2.4.1, 2014). The substance is not an irritant and therefore respiratory irritation is not anticipated either.
Justification for classification or non-classification
Based on the results, the substance does not need to be classified for skin eye and respiratory irritation/corrosion according to Regulation (EC) No. 1272/2008 and its amendments.
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