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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-300-4 | CAS number: 56634-95-8
- 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
Key, M-283361-01-1; skin irritation (rabbit, EPA OPP 81-5, GLP): not irritating
Key, M-280111-01-1; eye irritation (rabbit, EPA OPP 81-4, GLP): 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 - 21 Jul 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2015
- Deviations:
- yes
- Remarks:
- Age and weight of animals not reported, environmental and general conditions of animals not reported, no data on untreated skin
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: Young adults
- Weight at study initiation: not specified
- Housing: individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: 11 To: 21 Jul 1989 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100% actual test material as received
- The test item has been liquified by heating to 45 °C prior to treatment. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 10 days
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: a surgical gauze patch, held in place by non-irritating adhesive tape covered by semi-permeable dressing (orthopedic stockinette) loosely wrapped around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing: test sites were gently washed with tap water and gauze
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h; 7 and 10 days after washing
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All rabbits had erythema and edema that persisted through Day 7. The majority of edemas observed were very slight, scored with grade 1 in 5/6 animals. Well-defined erythemas were noted in all rabbits. 1 h after washing 3/6 animals revealed erythema of very mild degree (score 1). The remaining 3 animals showed erythema of grade 2. Ath the 24 h reading time point, 5/6 rabbits showed erythema of mild degree scored with grade 2. No skin reactions were noted latest on Day 10.
- Other effects:
- In individual cases sloughing of the skin of various thicknesses was observed at the 7 and 10 days reading time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The study is in accordance with EPA guideline no. 81-5 and was conducted under GLP conditions. Although the study possesses deviations from the current OECD guideline no. 404 (skin irritation), such as missing information on age and weight of animals, environmental and general conditions of animals, and no data on untreated skin, it is considered valid and reliable. Under the conditions chosen the test substance did not induce skin irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation 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:
- 10 - 17 Jul 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2021
- Deviations:
- yes
- Remarks:
- Age and weight of animals not reported, environmental and general conditions of animals not reported, no data on untreated eye, no anesthetics and systemic analgesics were applied
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adults
- Weight at study initiation: not reported
- Housing: individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: From: 10 Jul 1989 To: 17 Jul 1989 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 100% actual test material as received
- The test item has been liquified by heating to 45 °C prior to treatment. - Duration of treatment / exposure:
- 30 seconds (wash group)
continuous treatment (non-wash group) - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- non-wash group: 3 per sex
wash group: 3 males - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: either no washing was performed (non-wash group) or the treated eye was rinsed with deionized water for one minute (wash group)
- Time after start of exposure: 30 seconds (wash group only)
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 0.2% fluorescein sodium ophthalmic solution - Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of two animals scored (wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: one male was found dead on Day 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- male (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- female (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- female (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- female (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of two animals scored (wash group)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: one male was found dead on Day 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all six animals (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 to 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of two animals scored (wash group)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: one male was found dead on Day 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all six animals (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of two animals scored (wash group)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: one male was found dead on Day 1
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all six animals (non-wash group)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No effects on iris and cornea opacity were noted in any animal (wash and non-wash group). The test item induced conjunctivae redness in all animals of the non-wash group at the 1 h reading time point (6/6 animals scored grade 1). Full reversibility was observed after 4 (3/6 animals) to 7 days (3/6 animals). Chemosis was also observed at the 1 h reading time point for the non-wash group; 6/6 animals were scored grade 1 for this endpoint. In one animal the effect was already reversed after 24 h, in 3/6 animals after 48 h and in the remaining 2 animals after 72 h. In the wash group, conjunctivae redness was observed in all animals at the 1 h reading time point (grade 1) and full reversibility was observed after 72 h. In the same group, chemosis of grade 1 was noted in all three animals 1 h after exposure lasting until the 48 h reading time point.
- Other effects:
- One male of the wash group was found dead on Day 1 of the study (24 h after exposure). Positive fluorescein staining did not occur in any of the non-washed or washed eyes.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The study is in accordance with EPA guideline no. 81-4 and was conducted under GLP conditions. Although the study possesses deviations from the current OECD guideline no. 405 (eye irritation), such as missing information on age and weight of animals, environmental and general conditions of anima, no anesthetics and systemic analgesics were applied; in some animals washing occured 30 sec after substance instillation, it is considered valid and reliable. Under the conditions chosen the test substance did not induce eye irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritation 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/corrosion
The irritancy potential of the test substance to skin was evaluated according to EPA OPP 81-5 and in compliance with GLP (M-283361-01-1). The study is also in accordance with OECD guideline 404 with some deviations such as missing information on age, weight, housing conditions and general condition of animals and on untreated skin. In this study, the test item was liquified by heating to 45 °C prior to topical application of 0.5 mL test substance (purity 94.4%) to the clipped flank of 3 male and 3 female New Zealand White rabbits under a semi-occlusive dressing for 4 h. After patch removal, the skin was washed with water and scored for erythema and edema at reading time points 1, 24, 48, 72 h and 7 and 10 days after washing. All rabbits had erythema and edema that persisted through Day 7. The majority of edemas observed were very slight, scored with grade 1 in 5/6 animals. Well-defined erythemas were noted in all rabbits. 1 h after washing 3/6 animals revealed erythema of very mild degree (score 1). The remaining 3 animals showed erythema of grade 2. Ath the 24 h reading time point, 5/6 rabbits showed erythema of mild degree scored with grade 2. No skin reactions were noted latest on Day 10. The mean erythema score (24/48/72 h) was 2, 1.7, 1, 2, 2 and 2 for the six rabbits, respectively. The mean edema score over 24, 48 and 72 h was 1 in 5/6 rabbits and 1.3 in 1/6 rabbits. Sloughing of the skin of various thicknesses was observed in individual cases at the 7 and 10 days reading time point. 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 EPA OPP 81-4 to evaluate the eye irritancy potential of the test substance (M-280111-01-1). The study is also in accordance with OECD guideline 405 with some deviations such as missing information on age, weight, housing conditions and general condition of animals. The test material (94.4% purity) was liquified by heating to 45 °C prior to instillation of 0.1 mL into the eye of each of nine New Zealand White rabbits (6 males and 3 females). In three of the six male rabbits, the eyes were rinsed with deionized water for 1 minute 30 seconds after start of exposure (wash group). In the remaining animals, the eyes were not rinsed (non-wash group). One of the rabbits in the wash group was found dead on Day 1 of the study (24 h after washing). No effects on iris and cornea opacity were noted in any animal (wash and non-wash group). The test item induced conjunctivae redness in all animals of the non-wash group at the 1 h reading time point (6/6 animals scored grade 1). Full reversibility was observed after 4 (3/6 animals) to 7 days (3/6 animals). Chemosis was also observed at the 1 h reading time point for the non-wash group; 6/6 animals were scored grade 1 for this endpoint. In one animal the effect was already reversed after 24 h, in 3/6 animals after 48 h and in the remaining 2 animals after 72 h. In the wash group, conjunctivae redness was observed in all animals at the 1 h reading time point (grade 1) and full reversibility was observed after 72 h. In the same group, chemosis of grade 1 was noted in all three animals 1 h after exposure lasting until the 48 h reading time point. In the non-wash group the mean scores evaluated over 24, 48 and 72 h were 0.0 (iris, all six animals), 0.0 (opacity, all six animals), 1.0 (conjunctivae redness, all six animals) and 0.7, 0.7, 0, 0.3, 0.3 and 0.3 for the six animals exposed (chemosis). In the wash group, mean scores evaluated over 24, 48 and 72 h were 0.0 (iris), 0.0 (opacity), 0.7 (conjunctivae score) and 0.3 (chemosis) for both animals scored at these reading time points. In conclusion, the test substance did not exhibit eye-irritating properties in the conducted study.
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.
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.