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EC number: 214-787-5 | CAS number: 1194-65-6
- 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 test material was determined to be non-irritating according to a study performed in line with OECD Guideline 404 and EPA Guideline OPP 81-5.
EYE
The test material was determined to be non-irritating according to a study performed in line with OECD Guideline 405 and EPA Guideline OPP 81-4.
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:
- 03 June 1985 to 06 June 1985
- 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:
- yes
- Remarks:
- (three animals instead of six used)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- (three animals instead of six used)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-2.5 kg
- Housing: stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-20 °C
- Humidity: 685-85 %
- Air changes: 16 times per hour
- Photoperiod: 12 hours light/12 hours dark - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test material moistened with 1 % tragacanth suspension
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Type of wrap if used: 6 cm^2 aluminium foil patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness); eschar formation (injuries in depth) - 4
Oedema formation
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) - 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema or oedema was noted during the exposure or during the 72-hour observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating.
- Executive summary:
In a GLP compliant skin irritation study conducted in line with standardised guidelines OECD 404 and EPA OPP 85-1, the skin irritation of the test material was determined.
Under the conditions of the test, the test material was determined to be non-irritating.
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:
- 25 April 1983 to 02 May 1983
- 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:
- yes
- Remarks:
- (three animals instead of six used)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- (three animals instead of six used)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 60-80 %
- Air changes (per hr): 16 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Cornea
A. Opacity-degree of density
No ulceration or opacity - 0
Scattered or diffuse areas; details if iris clearly visible - 1
Easily discernible translucent areas, details of iris slightly obscured - 2
Opalescent areas of opacity, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible -4
B. Area of cornea involved
No damaged cornea - 0
One quarter (or less) but not zero - 1
Greater than one quarter but less than one half - 2
Greater than one half less than three quarters - 3
Greater than three quarters up to whole area - 4
Iris
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any one or all of these) - 2
Conjunctiva
A. Redness
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson read, individual vessels not easily discernible - 2
Diffuse beefy red - 3
B. Chemosis
No swelling - 0
Any swelling above normal - 1
Obvious swelling with partial eversion of the lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4
C. Discharge
Normal - 0
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) - 1
Discharge with moistening of the lids and hairs just adjacent to the lids - 2
Discharge with moistening of the lids and considerable area around the eye - 3 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects were observed on cornea, iris or conjunctiva.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating.
- Executive summary:
In a GLP compliant eye irritation study conducted in line with standardised guidelines OECD 405 and EPA OPP 81-4, the eye irritation of the test material was determined.
Under the conditions of the test, the test material was determined to be non-irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The key study (Koopman, 1985) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).
Eye
The key study (Koopman, 1983) was performed in line with GLP and standardised guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1 using the principle for assessing data quality as set out in Klimisch (1997).
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.
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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