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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-829-0 | CAS number: 57583-35-4
- 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: modified Primary Irritation Index 1.75; moderate irritant in rabbits
Eye irritation: conjunctival irritation produced which cleared by 24 hours in rabbits
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo study in the rabbit. The existing in vivo data is considered to fulfil the in vitro skin irritation/corrosion requirement.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, Massachusetts, USA
- Age at study initiation: approx 14-18 weeks
- Weight at study initiation: 2.7-3.5 kg
- Housing: 1/cage in suspended wire cages
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet #5321) daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C
- Humidity (%): 60-86%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark
IN-LIFE DATES: From: June 20, 2006 To: June 27, 2006 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site
- Concentration (if solution): N/A
VEHICLE- no vehicle - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 x 10 cm
- Type of wrap if used: piece of fabric (semi-occlusive) secured with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with paper towels saturated with tap water and blotted dry with paper towels
- Time after start of exposure: after 4 hours of exposure
SCORING SYSTEM:scored according to Draize technique - Irritation parameter:
- other: Modified Primary Irritation Index
- Basis:
- mean
- Time point:
- other: 4-hr
- Score:
- 1.75
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Edema was absent at 72 hours and on Day 7; Erythema was absent on Day 7
- Irritant / corrosive response data:
- Erythema was absent to well defined at 60 minutes, 24 hours and 48 hours following the 4 hour exposure. Erythema was absent to very slight at 72 hours and absent on day 7. Edema was absent to very slight at 60 minutes following the 4 hour exposure and absent to well defined at 24 and 48 hours. Edema was absent at 72 hours and on Day 7.
- Other effects:
- There were no abnormal physical signs noted during the observation period.
All body weight changes were normal. - Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: USEPA Review Manual, Chapter 8: Precautionary Labeling (1997)
- Conclusions:
- The test substance is a dermal irritant with a modified Primary Irritation Index of 1.75.
- Executive summary:
To determine the irritant or corrosive effects of the test substance when applied dermally. The study followed OECD test guideline 404. Since the test substance was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (2 males-1 female) were dosed dermally with the test substance. The substance (0.5 mL) was applied dermally to one intact site/rabbit. The test substance was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes after removal of the wrappings. Reactions were scored again at 24, 48 and 72 hours and on Day 7. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest, at 72 hours and at termination. A modified Primary Irritation Index was calculated using the 60 minute, 24, 48 and 72 hour scoring intervals.
Erythema was absent to well defined at 60 minutes, 24 hours and 48 hours following the 4 hour exposure. Erythema was absent to very slight at 72 hours and absent on day 7. Edema was absent to very slight at 60 minutes following the 4 hour exposure and absent to well defined at 24 and 48 hours. Edema was absent at 72 hours and on Day 7. There were no abnormal physical signs noted during the observation period. All body weight changes were normal. The test substance is a dermal irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study in the rabbit. The existing in vivo data is considered to fulfil the in vitro eye irritation requirement.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , control eyes were not scored at 1 hour.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: Approximately 4 months old
- Weight at study initiation: 2.2 – 2.6 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times /week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21◦C
- Humidity (%): 64-86 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 2006-07-03 To: 2006-07-06 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
VEHICLE- none - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated and control eyes of each rabbit were washed with saline following 24 hour observation interval for approximately one minute using a volume and velocity of flow which did not cause injury.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE:
Observations were performed using a Mini-Maglite® flashlight equipped with a high intensity bulb. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 hour
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 12
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Conjunctival irritation, noted in 3/3 eyes at 1 hour, cleared by 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Conjunctival irritation, noted in 3/3 eyes at 1 hour, cleared by 24 hours
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 24 hours.
- Other effects:
- There were no abnormal physical signs noted during the observation period
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Ocular administration produced conjunctival irritation which cleared by 24 hours.
- Executive summary:
To determine the irritant and/or corrosive effects, if any, of the test substance when instilled into the rabbit eye. Three healthy New Zealand White rabbits (2 males; 1 female) free from evidence of ocular irritation and corneal abnormalities, were dosed with 0.1 mL placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as control. The treated eye of each rabbit was examined and scored by the Draize technique at 1, 24, 48 and 72 hours postdose and the untreated eye was scored at 24, 48 and 72 hours. Both eyes were washed with saline following the 24 hour observation interval for approximately one minute using a volume and velocity of flow which did not cause injury. The eye irritation score for each rabbit was calculated each day. Body weights were recorded pretest and at termination.
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 24 hours. All three control eyes appeared normal at each observation period. There were no abnormal physical signs noted during the observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
GLP guideline studies were used to evaluate the irritation potential to the skin and eye of rabbits. Dermal reactions were scored at 60 minutes after wrap removal and again at 24, 48 and 72 hours and on Day 7. The treated eye of each rabbit was scored by the Draize technique at 1, 24, 48 and 72 hours postdose. The test substance was moderately irritating to the skin of rabbits, but not classified as an eye irritant.
In the skin irritation study, the test substance caused erythema and edema that was absent by 72 hours and Day 7, respectively. A modified Primary Irritation Index was calculated to be 1.75 and the test substance was determined to be a moderate irritant. In the eye irritation study, no corneal opacity or iritis was noted and conjunctival irritation, noted in 3/3 eyes, cleared by 24 hours. The test substance is not categorized as an ocular irritant.
Based on the available data for skin irritation, it is considered that although effects were seen on the skin of rabbits that these were not severe enough to warrant classification in accordance with the CLP criteria.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye irritation.
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.