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EC number: 442-450-4 | 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
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:
- 11 May - 03 Aug 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- test site area too small
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2008
- Deviations:
- yes
- Remarks:
- test site area 2.5 cm² instead of 6 cm², environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- step-wise testing was not performed but all animals were tested simultaneously, test site area 2.5 cm² instead of 6 cm², environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama LABES Co., Ltd. (Japan)
- Age at study initiation: 12 weeks
- Weight at dosing: 2.45 - 2.96 kg
- Housing: Individually, in aluminium cages (W450 x D550 x H350 mm).
- Diet: LRC-4 (Oriental Yeast Co., Ltd.), ca. 120 g/day
- Water: filtered tap water, ad libitum
- Acclimation period: 2 - 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): < 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: moistened - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was moistened in corn oil and spread on a 2.5 cm² lint patch and applied to the intact skin on the application site of the back of the animals.
- Type of wrap if used: The patch was held in contact with surgical tapes ("Blenderm" and "Micropore", 3M Co., Saint Paul, USA) and occluded with a pressure bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated areas were wiped with absorbent cotton dipped in acetone to clean off any remaining material.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Observations for skin irritations were made 1, 24, 48 and 72 h after patch removal. In addition, all animals were observed daily for clinical signs of toxicity.
SCORING SYSTEM:
- Method of calculation: Draize scoring - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- There were no skin irritation effects observed for any animal at any reading time point.
- Other effects:
- - Other adverse systemic effects: There were no clinical signs of toxicity observed for any animal during the whole study period.
- Interpretation of results:
- other: CLP/EU 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:
- 11 May - 03 Aug 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2008
- Deviations:
- yes
- Remarks:
- environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C), no stepwise testing performed
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no treatment with analgesic or anaesthesia of the animal /animal eyes prior, during or after treatment; environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C), no stepwise testing performed
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama LABES Co., Ltd. (Japan)
- Age at study initiation: 12 weeks
- Weight at dosing: 2.45 - 2.96 kg
- Housing: Individually, in aluminium cages (W450 x D550 x H350 mm).
- Diet: LRC-4 (Oriental Yeast Co., Ltd.), ca. 120 g/day
- Water: filtered tap water, ad libitum
- Acclimation period: 2 - 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): < 10
- 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 mL, corresponding to 0.029 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
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
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- There were no eye irritation reactions observed for any animal during the 72-h observation period.
- Interpretation of results:
- other: CLP/EU 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritating potential of Sumilizer GP was assessed in an in vivo skin irritation study conducted under GLP conditions and in accordance with EU Method B.4 / OECD guideline 404. 0.5 mg of the test item was moistend in corn oil and applied to the clipped skin of three male New Zealand White rabbits. The skin was exposed for 4 h under semi-occlusive conditions. Local skin reactions were assessed according to the Draize scoring system 1, 24, 48 and 72 h post administration.
There was no indication of skin irritation observed for any animal at any reading time point. The mean erythema and edema scores over 24, 48 and 72 h were equal to 0 for all 3 animals. Based on the experimental results and under the conditions of the study, the test item is considered not-irritant to the skin.
Eye irritation
The test item was investigated for eye irritating effects in New Zealand White rabbits according to EU Method B.5 / OECD guideline 405 and compliant with GLP. The test was conducted with three male rabbits, for which a single test item dose of 0.1 mL (corresponding to approx. 0.029 g) was installed into the conjunctival sac of one eye, the other eye serving as control. The eyes were examined for local effects 1, 24, 48 and 72 h after test item instillation and evaluated according to Draize criteria.
There were no eye irritating effects observed in any animal at any reading time point. The mean irritation scores on corneal opacity, iritis, conjunctival redness and chemosis over 24, 48 and 72 h were zero for all 3 animals. Based on the experimental results and under the conditions of the study, the test item has no eye irritating potential.
Justification for classification or non-classification
The available data on skin and eye irritation/corrosion do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.
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.
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