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EC number: 435-780-5 | 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
The substance is not a skin irritant, rabbit, OECD 404, Jones & Collier (1987)
Eye irritation
The substance is not an eye irritant, rabbit, OECD 405, Jones & Collier (1987)
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:
- 29 April 1987 to 6 May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK and David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: ca. 12 - 16 weeks
- Weight at study initiation: 2.40 - 3.12 kg
- Housing: Animals were housed individually in suspended metal cages
- Diet: ad libitum (Rabbit Diet, Preston Farmers Ltd., New Leake, Lincolnshire)
- Water: ad libitum
- Acclimation period: 5 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 24 hours before treatment, the dorsal/flank fur was clipped free of fur
- Coverage: each animals was treated by dermal application of 0.5 mL of test material
- Type of wrap if used: the test material was covered with a gauze patch of 2.5 x 2.5 cm. The patch was secured with surgical tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after application, the dressing was removed and the skin cleaned by gentle swabbing with cotton wool soaked in diethyl ether.
SCORING SYSTEM: skin reaction were scored using the Draize scoring system 1, 24, 48 and 72 hours after removal of test material. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test material was found not to be a skin irritant.
- Executive summary:
The potential of the test material to cause skin irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 404.
During the study three rabbits were exposed to 0.5 mL test material onto clipped skin for 4 hours using a semi-occulsive dressing. Skin reactions were assessed 1, 24, 48 amd 72 hours after exposure.
Exposure to the test material resulted in very slight erythema at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.
Based on these results, the test material was concluded not to be a skin irritant.
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:
- 1 June 1987 to 5 June 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK and David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: ca. 12 - 16 weeks
- Weight at study initiation: 2.36 - 3.32 kg
- Housing: Individually housed in suspended metal cages
- Diet: ad libitum (Rabbit Diet, Preston Farmers Ltd., New Leake, Lincolnshire)
- Water: ad libitum
- Acclimation period: 5 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21 °C
- Humidity (%): 65 - 68 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL test material was instilled into the in the conjunctival sac of the right eye of each rabbit by gently pulling the lower lid away from the eyeball. The lids were then gently held together for ca. 1 second to prevent loss of the test material. The other eye remained untreated and served as the control. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The eys of each animal were examined 1, 24, 48 amd 72 hours after instillation of the test material.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: The irritation reactions were scored using the Draize System.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light sourced from a standard ophthalmoscope. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No adverse corneal effects were noted in any treated eye during the observation period.
Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment.
Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the test material was not found to be irritating to the eyes.
- Executive summary:
The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 405.
During the study single samples of test material (0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test material resulted in no adverse corneal effects in any treated eye during the observation period. Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment. Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.
Based on the results of this study, the test material is not considered to be an eye irritant.
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 potential of the test material to cause skin irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 404.
During the study three rabbits were exposed to 0.5 mL test material onto clipped skin for 4 hours using a semi-occulsive dressing. Skin reactions were assessed 1, 24, 48 amd 72 hours after exposure.
Exposure to the test material resulted in very slight erythema at one treated skin site one hour after removal of the patches. Very slight erythema with or without oedema was noted at all treated skin sites at the 24-hour observation and at two treated skin sites at the 48 and 72-hour observations. Desquamation was also noted at one of these treated skin sites at the 72-hour observation. Desquamation only was apparent at two treated skin sites seven days after treatment.
Based on these results, the test material was concluded not to be a skin irritant.
Eye irritation
The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guideline OECD 405.
During the study single samples of test material (0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test material resulted in no adverse corneal effects in any treated eye during the observation period. Iridial inflammation was confined to one treated eye and noted only at the one hour observation, reversible and not observed 24 hours after treatment. Moderate conjunctival chemosis was noted in all treated eyes one hour after treatment but was reversible and not observed 24 hours after treatment. No conjunctival irritation was noted in any treated eye at subsequent 48 and 72 hour observations.
Based on the results of this study, the test material is not considered to be an eye irritant.
Justification for classification or non-classification
The substance does not fulfil the classification criteria for classification as a skin or eye irritant according to European Regulation (EC) No 1272/2008.
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