Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 245-740-7 | CAS number: 23564-05-8
- 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
The substance was tested for skin irritation in rabbits in a study similar to OECD TG 404. No skin irritation was observed in any of the six rabbits. The substance can be regarded as non-irritant to the skin.
TPM was tested for eye irritation in rabbits in a study similar to OECD TG 405. Instillation into the rabbit eye did not elicit a positive response in any of the six treated animals. Therefore, TPM was considered non-irritant to the rabbit eye.
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:
- 21 July 1986 - 21 November 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sizuoka Laboratory Animal Center (Sizuoka)
- Age at study initiation: about 3 months
- Weight at study initiation: 3.02 ± 0.20 kg (at dosing)
- Housing: individually housed in a steel mesh cages (33 x 45 x 35 cm)
- Diet: Standardized pellets of dry diet, RC-4 (Oriental Yeast Co., Ltd., Tokyo), ad libitum
- Water: tap water, ad libitum
- Acclimation period: quarantined for a week prior to use
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 25 (mean temperature: 21.1)
- Humidity (%): 40 - 80 (mean humidity at 9 am: 59.6)
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin changes such as erythema and edema were scored at 0, 0.5, 1, 24, 48 and 72 hours after the removal of the test item.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 3 cm²
REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period, the patch was removed and the skin was wiped (but not washed) to remove any test substance still remaining.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 0, 0.5, 1, 24, 48 and 72 hours after the removal of the test item
SCORING SYSTEM:
- Method of calculation: Draize scoring - Irritation parameter:
- erythema score
- Basis:
- animal: #1 -#6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined not to be irritating to the skin.
- Executive summary:
In this assessment of the primary dermal irritation, 0.5 g of the test item moistened with water was spread over lint patches which were kept in contact the skin of 6 rabbits. Four hours after the application the patch was removed and the skin was wiped to remove any test substance still remaining. The dermal irritation scores were recorded after removal of the patches. No skin reaction was observed in any rabbits treated with the test item. The test item was determined not to be irritating to the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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:
- 21 July 1986 - 13 November 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sizuoka Laboratory Animal Center (Sizuoka)
- Age at study initiation: about 3 months
- Weight at study initiation: 2.91 ± 0.19 kg (at dosing)
- Housing: individually housed in a steel mesh cages (33 x 48 x 35 cm)
- Diet: Standardized pellets of dry diet, RC-4 (Oriental Yeast Co., Ltd., Tokyo), ad libitum
- Water: tap water, ad libitum
- Acclimation period: quarantined for a week prior to use
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 25 (mean temperature: 20.7)
- Humidity (%): 40 - 80 (mean humidity at 9 am: 68.3)
- Photoperiod (hrs dark / hrs light): 12 / 12 - Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 6 animals: eyes were not washed out
3 animals: eyes washed with water 2 minutes after treatment - Observation period (in vivo):
- Readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the treatment.
- Number of animals or in vitro replicates:
- 3 animals (eyes washed with water) and 6 animals (eyes not washed out)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 6 animals: no washing; 3 animals: washing with water
- Time after start of exposure: 2 minutes
SCORING SYSTEM: in accordance with scoring system according to OECD 405 - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1-#6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #6 (unwashed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #3 (washed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined not to be irritating to the eye.
- Executive summary:
In this assessment of the primary irritation to the eye, 0.1 g of the test item was applied to each left eye of 9 rabbits. The treated eyes of 3 rabbits were washed by water and those of 6 rabbits were not washed. The readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the application of the test item in comparison with the untreated right eyes. Very mild changes were observed in treated eyes of all animals whose eyes have been washed out and in 4 animals whose eyes have not been washed out. No irritation to the eyes was observed after 24, 48 or 72 hours. Therefore, the test item was determined not to be irritating to the eye.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In this assessment of the primary dermal irritation, 0.5 g of the test item moistened with water was spread over lint patches which were kept in contact the skin of 6 rabbits. Four hours after the application the patch was removed and the skin was wiped to remove any test substance still remaining. The dermal irritation scores were recorded after removal of the patches. No skin reaction was observed in any rabbits treated with the test item. The test item was determined not to be irritating to the skin.
Eye irritation
In this assessment of the primary irritation to the eye, 0.1 g of the test item was applied to each left eye of 9 rabbits. The treated eyes of 3 rabbits were washed by water and those of 6 rabbits were not washed. The readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the application of the test item in comparison with the untreated right eyes. Very mild changes were observed in treated eyes of all animals whose eyes have been washed out and in 4 animals whose eyes have not been washed out. No irritation to the eyes was observed after 24, 48 or 72 hours. Therefore, the test item was determined not to be irritating to the eye.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for skin irritation/corrosion and eye irritation/corrosion are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is neither considered to be classified for skin irritation/corrosion nor for eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.