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EC number: 433-460-1 | CAS number: 210880-92-5
- 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:
- 17 - 28 Sep 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2015
- Deviations:
- yes
- Remarks:
- housing conditions slightly divergent, 6 animals were used, body weights only noted at the start of study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, UK
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.42 - 2.85 kg
- Housing: individually housed in floor-pens with a minimum floor area of 0.6 m²
- Diet: pelleted SQC TRB Rabbit Diet 9603 (Harlan Teklad, Bicester, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 40 - 80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 10/14
IN-LIFE DATES: From: 17 Sep 1996 To: 28 Sep 1996 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- The dermal test site was moistened with 0.1 mL distilled water immediately before application.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 0.1 mL distilled water was immediately applied on the dermal test site before application - Duration of treatment / exposure:
- 4 h
- Observation period:
- Observation period: 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 female (step 1) and 5 males (step 2)
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm area
- Type of wrap if used: test site was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive bandage was wrapped firmly around the torso (semi-occlusive dressing)
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was lightly brushed clean of any solid residues and swabbed with moist cotton wool
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation reactions or other dermal changes were observed hi any animal at any time during the observation period.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.
- Conclusions:
- The study is in concordance with the OECD TG 404 (1992). Therefore, the study is considered acceptable and the outcome can be reported as valid.
A single semi-occlusive application of 0.5 g test substance to intact rabbit skin for 4 h elicted no skin irritation reaction. The individual mean score for the 24, 48 and 72-h readings were 0 for all animals. According to the criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.
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:
- 24 Sep - 04 Oct 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2020
- Deviations:
- yes
- Remarks:
- housing conditions slightly divergent, 6 animals were used, body weights only noted at the start of study, no anaesthetics used
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, UK
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.10 - 2.47 kg
- Housing: individually in floor-pens with a minimum floor area of 0.6 m²
- Diet: pelleted SQC TRB Rabbit Diet 9603 (Harlan Teklad, Bicester, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 40 - 80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 10/14
IN-LIFE DATES: From: 10 Sep 1996 To: 04 Oct 1996 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 66 mg (the weight equivalent to 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- Observation period: 72 h
Reading time points: 0.5, 1, 4, 24, 48 and 72 h. - Number of animals or in vitro replicates:
- 1 male (step 1) and 5 males (step 2)
- Details on study design:
- TREATMENT OF THE ANIMALS
One dose consisting of 66 mg (the weight equivalent to 0.1 mL) in powder form was instilled into the left conjunctival sac of the rabbit (step 1). The lower eyelid was gently prised away from the eyeball to create a receptacle for the dose. After instillation the eyelids were held closed for a few seconds to prevent loss of the dose. The right eye remained untreated and served as a control to the treated eye. After observing the (lack of) effect on the treated eye, 5 additional male rabbits were treated.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Fluorescein at the 24-h reading time point - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Mild conjunctivae (score 1) was noted in 6/6 animals during the 1-h reading time point. All conjunctival irritation reactions resolved within 24 h of treatment and were not observed thereafter. The cornea and iris were unaffected by the test substance.
- Other effects:
- No observations indicative of systemic toxicity or ill health were noted for any
rabbits during the course of the study. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 12 72/2008.
- Conclusions:
- The study is in accordance with OECD TG 405, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did not induce irritation to the eye of rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritancy is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The irritancy potential of the test substance to skin was evaluated in a study according to OECD guideline 404 and in compliance with GLP (M-027402-01-1). The test substance was applied as powder to a 30 x 20 mm area on the clipped and moistened dorsum of one female New Zealand White rabbit under a semi-occlusive dressing for 4 h. As the test item did not cause severe dermal changes, subsequently, 5 rabbits were subjected to a single, 4-h, semioccluded topical application of 500 mg of test article. The test item did not induce irritant or corrosive effects determined 1, 24, 48 and 72 h after removal of the dressing. Mean scores evaluated over 24, 48 and 72 h were 0.0 for erythema and edema for each animal. In conclusion, the test substance did not exhibit skin irritating properties in the conducted study.
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-027400-01-1). Initially, a single dose of 66 mg test substance (step 1) was instilled into the left conjunctival sac of one male New Zealand White rabbit without washing. In step 2, as the test substance did not cause ocular damage, the test item was instilled in the eyes of 5 rabbits. The individual ocular responses were observed 0.5, 1, 4, 24, 48 and 72 h after instillation of the test item. The test substance caused practically no initial sting reaction in five rabbits and a slight initial sting response in one animal. Slight conjunctivae (score 1) was observed up to 4 h following treatment in all animals and chemosis (score 1) in 1/5 animals was reported. However, 24, 48 and 72 h after treatment, no ocular findings were observed. Mean scores evaluated over 24, 48 and 72 h were 0.0 for chemosis, conjunctivae, iris and cornea opacity for each animal. 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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