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EC number: 444-960-2 | CAS number: 39148-16-8
- 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): not irritating
Eye irritation (OECD 405): 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:
- 16 - 24 May 2002
- 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 July 1992) and current version of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted in July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (adopted August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Republique Francaise, Premier Ministre, Groupe Interministeriel Des Produits Chimiques, Paris Cedex, France
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.6 ± 0.2 kg
- Housing: individually in polystyrene cages
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: filtered water (FG Millipore membrane (0.22 micron)), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): (12 / 12) - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the gauze pad was moistened with distilled water prior to treatment to ensure good contact with the skin
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 3 min and 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 male (initial test, treatment for 3 min on one flank and for 4 h on the other flank)
2 males (4 h exposure) - Details on study design:
- TEST SITE
- Area of exposure: 3 min exposure: left flank (initial test animal); 4 h exposure: right flank (3 test animals)
- Type of wrap if used: The treated skin was covered by an adhesive hypoallergenic aerated dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was wiped off with a dry cotton pad.
- Time after start of exposure: 3 min (initial test animal) or 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Topical application of the test substance for 3 min did not induce cutaneous reactions in the initial test animal. After elongation of the exposure time to 4 h, one animal revealed a very slight erythema (scored with grade 1) visible 1 h after removal of the dressing. No skin reactions were noted at the following reading time points.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions chosen, the test substance did not induce skin irritation to the skin of rabbits.
Reference
Table 1: Four -hour exposure - Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48, and 72 hours)
Observation time |
Rabbit no. |
||||||
1 |
2 |
3 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
1 h |
0 |
0 |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean value 24 + 48 + 72 h |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
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:
- 23 May - 31 May 2002
- 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 February 1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- yes
- Remarks:
- No systemic analgesic was used sixty minutes before application, local analgesic applied two minutes prior to treatment instead of five minutes, no use of systemic analgesic after treatment
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (adopted in July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (adopted in August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Republique Francaise, Premier Ministre, Groupe Interministeriel Des Produits Chimiques, Paris Cedex, France
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.8 ± 0.2 kg
- Housing: individually in polystyrene cages
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: filtered water (FG Millipore membrane (0.22 micron)), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): (12 / 12) - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single application without washing
- 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:
- SCORING SYSTEM: Draize scoring system supplemented with scoring scale for discharge and area of opacity
TOOL USED TO ASSESS SCORE: fluorescein (on Day 2 and repeated thereafter whenever necessary) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48
- Irritant / corrosive response data:
- The test item induced slight to moderate effects on the conjunctivae (redness) in 3/3 test animals scored with grade 2 in 2/3 (animal # 2 and 3) and grade 3 in 1/3 animals (animal #1) 1 h after instillation of the test substance. Moreover, chemosis was observed in 3/3 animals at the same reading time point graded with 2 (animal #2) or 3 (animal # 1 and 3). 24 h after substance instillation, chemosis was observed in 2/3 animals (grade 1) which was fully reversible at the 48 h reading time point. Effects on the conjunctivae (redness) were still visible after 24 h (animal #2, grade 1; animal #1 and 3, grade 2) or 48 h (animal #1 and 3, grade 1) but were completely reversible in all animals after 72 h at the latest. No other ocular reactions were observed in the test animals.
- Other effects:
- Clear to whitish purulent discharge was noted in all animals (grade 2), which was reversible latest 48 h after instillation of the test substance.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions chosen, the test substance did not induce irritation to the eyes of rabbits.
Reference
Table 1: Results of eye irritation study
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
3 |
3 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.0 |
0.0 |
0.0 |
0.0 |
|
2 |
1 |
2 |
2 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.3 |
0.3 |
0.0 |
0.0 |
|
3 |
1 |
2 |
3 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.0 |
0.3 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
The irritancy potential of the test substance to skin was evaluated according to OECD guideline 404 and in compliance with GLP (M-211140-01-1). In an initial test, 0.5 g test substance (81.8% purity) were placed on a dry gauze pad moistened with water, which was applied to the closely-clipped skin of the left or right flank of a single New Zealand White rabbit under a semi-occlusive dressing for 3 min and 4 h, respectively. As no cutaneous reactions were observed in this animal, the test substance was topically applied for 4 h to 2 further test animals. The untreated skin served as control. The test item did not induce irritant or corrosive effects determined 1, 24, 48 and 72 h after removal of the dressing despite a very slight erythema (scored with grade 1) observed in one test animal 1 h after removal of the dressing. No other cutaneous reactions were observed until the end of the study. Mean scores evaluated over 24, 48 and 72 h were 0.0 for erythema and oedema for each animal.
Furthermore, 0.5 mL of an aqueous test solution with a content of 22.1% test substance were applied topically to the clipped skin of 3 New Zealand White rabbits under semi-occlusive dressing according to OECD Guideline 404 and GLP in a supporting study (M-207091-01-1). Dermal exposure to the test substance for 4 h did not induce cutaneous reactions in any test animal scored 1, 24, 48 and 72 h after removal of the dressing.
In conclusion, the test substance did not exhibit skin irritating properties in the conducted studies.
Eye irritation
A GLP-conform eye irritation/corrosion study was performed according to OECD Guideline 405 to evaluate the eye irritancy potential of the test substance (M-211144-01-1). Initially, a single dose of 0.1 g test substance (purity 81.1%) was instilled to the eye of one male New Zealand White rabbit without washing. As the test substance was not severely irritant, the test item was instilled in the eyes of two further rabbits after application of a local anaesthetic (Novesine® at 0.4% oxybuprocaine). The test item induced slight to moderate effects on the conjunctivae (redness) in 3/3 test animals scored with grade 2 in 2/3 and grade 3 in 1/3 animals 1 h after instillation of the test substance. Moreover, chemosis was observed in 3/3 animals at the same reading time point graded with 2 (1/3 animals) or grade 3 (2/3 animals). 24 h after substance instillation, chemosis was observed in 2/3 animals (grade 1) which was fully reversible 48 h after instillation of the test substance. Effects on the conjunctivae (redness) were still visible after 24 h (1/3 animals: grade 1; 2/3 animals: grade 2) or 48 h (2/3 animals: grade 1) but were fully reversible after 72 h at the latest. Mean values of 1/0.3/1 and 0/0.3/0.3 were derived for the effects on the conjunctival redness and chemosis induced in the test animals 1 -3, respectively, calculated over the 24, 48 and 72 h reading time points. No ocular reactions on the cornea or iris were observed.
Moreover, a single dose of 0.1 mL of an aqueous solution with a content of 22.1% test substance was applied to the eyes of 3 male New Zealand White rabbits following OECD Guideline 405 (M-207087-01-1). Instillation of the test solution induced very slight chemosis (grade 1) and conjunctival redness (grade 1) in 2/3 animals observed 1 h after substance instillation which were reversible latest 72 h after substance instillation. Mean values of 0/0.3/0 and 0/0.7/0 were derived for conjunctival redness and chemosis in the test animals 1 -3, respectively, calculated over the 24, 48 and 72 h reading time points. No further ocular reactions were determined until the end of the observation period.
In conclusion, the test substance did not exhibit eye irritating properties in the conducted studies.
Justification for classification or non-classification
The available data on skin 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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