Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 944-042-6 | 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
Not skin irritant.
Eye Irrit. 2, H319
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:
- November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 363/1995, of 10 March
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 1078/93 of 2 July
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized breeder.
- Weight at study initiation: 2001, 2453, 2607 g
- Housing: single housed in a stainless steel cage, brand Tecniplast.
- Diet: daily dose of 150 g special diet for rabbits experimental provided by an authorized provider.
- Water: filtered tap water, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH with air filtered 5 µm.
- Photoperiod: 12 hour cycle dark/light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours, 7, 14 and 21 days
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 20 cm x 13 cm
- Coverage: 6 cm^2
- Type of wrap if used: Gauze type dressings (Melolin) or equivalent, Sticking plaster, hypoallergenic adhesive bandage (Fixomull Seretch) or equivalent.
REMOVAL OF TEST SUBSTANCE
- Washing: yes; after the exposure period the substance is gently removed with water or suitable solvent.
EVALUATION OF SKIN REACTIONS
Eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...4
Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- other: animal 2 and 3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Other effects:
- In the three animals was observed a brown skin coloured into the application site. This effect persists after 21 days in the rabbit no. 1 and disappears after 14 days in the rabbits no. 2 and no. 3.
- Interpretation of results:
- other: Not classified, according to the Regulation EC 1272/2008 (CLP)
- Conclusions:
- The substance was tested following method described in the Spain Royal Decree 363/1995 and Royal Decree1078/93. Under the experimental conditions the substance does not show skin irritation properties.
- Executive summary:
The substance has been tested for skin irritation according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree1078/93.
Three male rabbits are tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion.
The values of erythema and oedema, calculated as mean individual scores at 24, 48 and 72 hours, are below the trigger values for classification (2.3), therefore the substance is not classified under the CLP Regulation (EC n. 1272/2008).
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The procedure of the test did not include the rinsing of the eye. Due to the intrinsic irritating nature of dusty materials, the experiments could have overestimated the irritating potential of the substance related to its chemical/toxicological properties.
- Qualifier:
- according to guideline
- Guideline:
- other: Real Decreto 363/1995 of 10 March
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Real Decreto 1078/93 of 2 July
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Tecniplast inox cages.
- Diet: 150 g per day standard diet.
- Water: tap water; ad libitum.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH
- Photoperiod: 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g fine powder.
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and at 7, 14 and 21 day after application.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
Cornea
Opacity: degree of density
No ulceration or opacity........................................................................................... 0
Scattered or diffuse areas of opacity .................................................................... 1
Easily discernible translucent area, details of iris slightly obscured........................2
Nacrous area, no details of iris visible, size of pupil barely discernible.................. 3
Opaque cornea, iris not discernible through the opacity..........................................4
Iris
Normal...................................................................................................................... 0
Markedly deepened rugae, congestión, swelling ................................................... 1
No reaction to light, hemorrhage, gross destructlon (any or all of these) ...............2
Conjunctivae - redness
Blood vessels normal ...............................................................................................0
Some blood vessels definitely hyperemic (injected) ................................................1
Diffuse, crimson color, individual vessels not easily discernible............................. 2
Diffuse beefy red......................................................................................................3
Conjunctivae - chemosis
No swelling............................................................................................................... 0
Any swelling above normal (includes nictitating membranes)..................................1
Obvious swelling with partial eversión of lids.......................................................... 2
Swelling with lids about half closed .........................................................................3
Swelling with lids more than half-closed...................................................................4
TOOL USED TO ASSESS SCORE: hand-slit lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- other: 3/3 animals
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- other: 3/3 animals
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- other: 2/3 animals
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- At rabbit #2 and #3, on 21th day, was given a conjunctival redness score of 1.
- Irritation parameter:
- chemosis score
- Basis:
- other: 2/3 animals
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
- Interpretation of results:
- other: Classified as Eye Irrit. 2, according to the Regulation EC 1272/2008 (CLP).
- Conclusions:
- The substance was tested for eye irritation following a mehod described in the Real Decreto 363/1995.Under the experimental conditions the substance is classified as Eye Irrit. 2, H319.
- Executive summary:
The test was performed according to the Real Decreto 363/1995.
The eye irritation potential was investigated by instillation of the equivalent of 0.1 g/animal of the test substance. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion, as stated by the Regulation EC 1272/2008 (CLP).
Findings
Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.
Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.
Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).
From the present results the substance should be classified as corrosive to the eyes bacause the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.
Since the study did foresee the rising of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.
Reference
Mean values for cornea, iris, conjunctiva at 24, 48 and 72 hours.
Rabbit #1 | Rabbit #2 | Rabbit #3 | Mean | |
Corneal opacity | 1 | 1 | 1 | 1 |
Iritis | 0 | 0.67 | 1 | 0.55 |
Conjunctival redness | 2 | 2.67 | 3 | 2.55 |
Conjunctival oedema | 0.67 | 3 | 3.67 | 2.44 |
Individual findings - Rabbit #1 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | - | 1 | 1 | 1 | 0 | 0 | 0 |
Iritis | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjunctival redness | 3 | 2 | 2 | 2 | 2 | 1 | 0 |
Conjunctival oedema | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
Individual findings - Rabbit #2 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
Iritis | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Conjunctival redness | 0 | 3 | 3 | 2 | 2 | 2 | 1 |
Conjunctival oedema | 3 | 4 | 3 | 2 | 1 | 0 | 0 |
Individual findings - Rabbit #2 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Iritis | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Conjunctival redness | 0 | 3 | 3 | 3 | 2 | 2 | 1 |
Conjunctival oedema | 3 | 4 | 4 | 3 | 2 | 1 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation assessment
The assessment was based on a study made in 2000 according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree 1078/93.
Three male rabbits were tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. Under the conditions of the present experiment the substance was found to cause no irritation when applied to intact rabbit skin.
Eye irritation assessment
The assessment was based on a study made in 2001 according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree 1078/93.
The eye irritation potential was investigated by instillation of the equivalent of 0.1 g/animal of the test substance. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion, as stated by the Regulation EC 1272/2008 (CLP).
Experimental findings:
Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.
Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.
Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).
From the present results the substance should be classified as corrosive to the eyes bacause the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.
Since the study did foresee the rising of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:
Skin irritant cat2:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; o
3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Eye irritant Cat 2:
at least in 2 of 3 tested animals, a positive response of:
1) corneal opacity ≥ 1 and/or
2) 2) iritis ≥ 1, and/or
3) conjunctival redness ≥ 2 and/or
4) conjunctival oedema (chemosis) ≥ 2
5) calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Regarding the substance
Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.
Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.
Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).
From the present results the substance should be classified as corrosive to the eyes bacause the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.
Since the study did not foresee the rinsing of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.
For the above mentioned reason, the substance does not meet the criteria for classification as Eye Damage 1. Instead, a classification as Eye Irrit 2, under the Regulation EC 1272/2008 (CLP), is warranted.
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.