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EC number: 443-870-0 | CAS number: 163520-33-0
- 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:
- 08 - 11 Mar 1994
- 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:
- Current version adopted in 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Guideline in place during study conduct: adopted in 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- Adopted in 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 25 - 26)
- Version / remarks:
- Adopted in 1985
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 3 - 5 months
- Body weight at study initiation: 2.4 - 2.5 kg
- Housing: individually in separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g daily
- Water: tap water in drinking water quality, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 Mar 1994 To: 11 Mar 1994 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Polyethylene glycol 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 0.35 mL
- Concentration: 0.5 g of the test substance were moistened with 0.35 mL polyethylene glycol 400 - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations of the skin took place 30 - 60 min, and 24, 48, and 72 h after removal of the patch.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The moistened test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Beiersdorf AG, Hamburg, Germany). The plaster was fixed to the prepared skin area and then covered with a semiocclusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with warm tap water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
30 - 60 min, and 24, 48, and 72 h after removal of the patch
SCORING SYSTEM:
- Method of calculation: Erythema, eschar formation, and oedema were evaluated numerically according to the Draize scoring system. - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance caused no dermal reactions in any of the test animals throughout the observation period.
- Other effects:
- No clinical signs of systemic toxicity were observed during the observation period.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- Based on the results of the present study, the test substance is considered to be non-irritating to the skin of rabbits.
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:
- 15 - 22 Feb 1994
- 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:
- Current version adopted in 2017 and corrected in 2020
- Deviations:
- yes
- Remarks:
- No pretreatment with a systemic analgesic and no induction of appropriate topical anesthesia.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Guideline in place during study conduct: adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- Adopted in 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 23 - 24)
- Version / remarks:
- Adopted in 1985
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 3 - 5 months
- Body weight at study initiation: 3.4 - 3.6 kg
- Housing: individually in separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g daily
- Water: tap water in drinking water quality, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Feb 1994 To: 22 Feb 1994 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- Reading time points: 1, 24, 48, and 72 h and 7 days
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with physiological saline at approx. 37 °C
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At the 1 h reading time point 2/3 rabbits displayed inflammation of the iris (grade 1 of max. 2). In addition, in all 3 animals conjunctival reddening (grade 1 or 2 of max. 3), chemosis (grade 1 of max. 4) and discharge (grade 2 of max. 3) were observed. At the 24 and 48 h reading time points, inflammation of the iris (grade 1) was still evident in animal #2, only. Conjunctival reddening was seen in animal #1 (grade 1) after 24 h and in animal #2 after 24 (grade 2), 48 (grade 2), and 72 h (grade 1). In animal #2 conjunctival chemosis as well as discharge were noted after 24 (grade 2) and 48 h (grade 1). Chemosis (grade 1) was still detected 72 h post administration. In animal #1 and #3 irritating effects were less pronounced than in animal #2 and fully reversible within 48 h. In animal #2 effects were fully reversible within 7 days.
- Other effects:
- No clinical signs of systemic toxicity were observed during the study.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- Based on the results of the present study, the test substance has no eye irritation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is one GLP-conform OECD 404 guideline study available, assessing the irritating effects of the test substance to the skin (M-133267-01-1, 1994). The test was performed in 3 female New Zealand White rabbits which were exposed for 4 h to 0.5 g of the test substance under semiocclusive conditions. The skin irritation effects were scored at reading time points 1, 24, 48, and 72 h. No dermal reactions were caused by the test substance in any of the test animals during the 72-h observation period. In addition, no clinical signs of systemic toxicity were observed throughout the test.
The irritating effects of the test substance to the eyes were assessed in a GLP study performed according to OECD guideline 405 (M-133142-01-1, 1994). The left eye of three female New Zealand White rabbits was treated with 0.1 g of the test substance and rinsed after 24 h. Observations were conducted 1, 24, 48, and 72 h after removal of the test substance. At the 1-h reading time point 2/3 rabbits displayed inflammation of the iris (grade 1). In addition, in all 3 animals conjunctival reddening (grade 1 or 2), chemosis (grade 1) and discharge (grade 2) were evident. At the 24- and 48-h reading time point inflammation of the iris (grade 1) was still evident in animal #2, only. Conjunctival reddening was seen in animal #1 (grade 1) after 24 h and in animal #2 after 24 h (grade 2), 48 h (grade 2) and 72 h (grade 1). In animal #2 conjunctival chemosis as well as discharge were noted after 24 h (grade 2) and 48 h (grade 1). Chemosis (grade 1) was still detected 72 h post administration. In conclusion, irritating effects if any were less pronounced in animal #1 and 3 than in animal #2 and fully reversible within 48 h. In animal #2 effects were fully reversible within 7 days. No clinical signs of systemic toxicity were observed during the study.
Justification for classification or non-classification
The available data on skin irritation/corrosion and eye irritation of the test substance 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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