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EC number: 810-161-6 | CAS number: 1229654-66-3
- 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 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: not irritating
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 Apr - 06 Apr 2013
- 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:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted in 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GYEMSZI, National Institute for Quality- and Organizational Development in H ealthcare and Medicine, Budapest, Hungary
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-Lap Co.Ltd., Kartal, Hungary
- Age at study initiation: 13 - 14 weeks
- Housing: individually in AAALAC approved metal wire rabbit cages
- Diet: UNI diet for rabbits (Agribands Europe Hungary PLC, Karcag, Hungary), ad libitum
- Water: tap water from the municipal supply, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.8 - 20.9
- Humidity (%): 24 - 56
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- approximately 24 h before application
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Duration of treatment / exposure:
- Initially, a single animal was treated for 1 h. As no significant irritant effect was observed after the 1 h exposure, the test was completed using the 2 remaining animals with an exposure period of 4 hours.
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm²
- Type of wrap: the test material was held in contact with the skin by gauze pads dampened with water to ensure good contact with the skin. An adhesive hypoallergenic plaster kept the gauze pads in contact with the skin. The entire trunk of the animals was then wrapped with plastic wrap with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h
SCORING SYSTEM:
- Method of calculation: numerical scoring system listed in the Commission Directive 2004/73/EC 2004 which is based on the Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Very slight erythema (score 1) was noted in all animals at 1 h after patch removal and very slight erythema (score 1) was noted in two rabbits 24 hours after patch removal.
- Other effects:
- - Other adverse local effects: At the observation time points, 48 and 72 h after patch removal, there were no local signs on the skin of the treated animals.
- Other adverse systemic effects: No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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:
- 22 - 28 May 2013
- 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:
- adopted in 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted in 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GYEMSZI National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2765 - 2803 g
- Housing: individual in AAALAC approved metal wire rabbit cages
- Diet: diet for rabbits (Agribands Europe Hungary PLC, Karcag, Hungary), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1 - 20.1
- Humidity (%): 40 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with physiological saline solution.
- Time after start of exposure: 1 h
SCORING SYSTEM: Draize scoring system and OECD 405
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- - Lesions and clinical observations: There were no mortalities and no clinical signs of systemic toxicity observed during the study. The general state and behaviour of animals were normal throughout the study period.
- Ophthalmoscopic findings: Fluorescein staining was negative in all animals during the observation period.
- Other observations: Discharge was noted 1 h post application in 3/3 males but was reversible within 24 h. The body weight and body weight changes were considered to be normal with no indication of any treatment related effect. - Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Table 1 Individual mean scores
Animal number |
Effects |
24 h |
48 h |
72 h |
Mean scores |
Response |
Reversible (days) |
1 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 0 1 1 0 |
0 0 1 0 0 |
0 0 0 0 0 |
0.00 0.00 0.67 0.33 0.00 |
- - - - - |
na na 3 2 1* |
2 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 0 1 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0.00 0.00 0.33 0.00 0.00 |
- - - - - |
na na 2 1* 1* |
3 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 0 1 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0.00 0.00 0.33 0.00 0.00 |
- - - - - |
na na 2 1* 1* |
-- = negative, na = not applicable, * = in respect of the result 1 h post application
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable studies regarding skin irritation/ corrosion and eye irritation/ corrosion are available for the test substance.
Skin:
The acute skin irritation potential of the test substance was assessed in a study performed according to OECD Guideline 404 and in compliance with GLP (M-462513-01-1). Three male young adult New Zealand White rabbits were treated by topical semi-occlusive application of 0.5 g of the test item to the intact shaved flank for 4 h. The treated skin surface was examined at 1, 24, 48 and 72 hours after patch removal. Irritation was scored by the method of Draize as described in the OECD guideline 404. Very slight erythema (score 1) was noted in all animals at 1 hour after patch removal and very slight erythema (score 1) was noted in two rabbits 24 h after patch removal. The mean scores for the 24, 48 and 72 h reading for erythema were 0.33 for 2/3 and 0.0 for 1/3 animal. The mean score for the 24, 48 and 72 h reading for edema for each animal was 0, respectively. No mortality occurred and no clinical signs of systemic toxicity were observed during the study. The body weights of all rabbits were considered to be within the normal range of variability. Thus, under the conditions of this study, the test substance is a mild irritant to the skin of male New Zealand White rabbits. The very slight erythema observed in all animals was reversible within 48 h post-treatment. The results of the study do not trigger a classification of the test substance according to Regulation (EC) No 1272/2008 and thus, the test substance is considered to be not irritant to the skin.
Eye:
The acute eye irritation potential of the test substance was assessed in a study performed according to OECD Guideline 405 and in compliance with GLP (M-462510-01-1). 0.1 g of the test substance was placed into the conjunctival sac of the left eye of three male young adult New Zealand White rabbits. The eyes were washed 1 h after application and examined 1, 24, 48 and 72 h after application. The untreated right eye of each animal served as control. Fluorescein staining was performed 24 h before administration and 24, 48 and 72 h after application. One hour after the application, conjunctival redness (score 2), chemosis (score 2 or 1) and discharge (score 2) was noted in all rabbits. At 24 h after treatment, conjunctival redness (score 1) was noted in all animals and chemosis (score 1) was noted in 1/3 rabbit. At 48 h after treatment, conjunctival redness (score 1) was noted in 1/3 animal. At 72 h after treatment, no clinical signs, and no conjunctival or corneal effects were observed. The mean scores for the 24, 48 and 72 h reading for conjunctivae were 0.67 for 1/3 and 0.33 for 2/3 animals. The mean chemosis scores for the 24, 48 and 72 h reading were 0.33 for 1/3 and 0 for 2/3 animals. The mean scores for the 24, 48 and 72 h reading for cornea opacity and iris for each animal were 0, respectively. Fluorescein staining was negative in all animals during the observation period. There were no notable body weight changes during the study period. Thus, under the conditions of this study, the test substance caused conjunctival irritant effects and chemosis in the eye of male New Zealand White rabbits. The observed effects were fully reversible within 72 h post-treatment in all animals. The results of the study do not trigger a classification of the test substance according to Regulation (EC) No 1272/2008 and thus, the test substance is considered to be not irritant to the eyes.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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