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EC number: 215-582-3 | CAS number: 1333-22-8
- 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
Skin irritation/corrosion
A study was performed to OECD 404 to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Eye irritation
A study was performed to OECD 405 to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
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:
- Experimental phase: 13 February 2002 and 16 February 2002. Report issue: 13 June 2002.
- 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 (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-10 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually in suspended cages
- Diet: Free access to food (Certified rabbit diet) was allowed throughout the study
- Water : Free access to mains drinking water was allowed throughout the study
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg. C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored accordingly.
- Number of animals:
- Three.
- Details on study design:
- TEST SITE
- Area of exposure: back of each rabbit
- Coverage: 2.5 cm x 2.5 cm patch
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours - Irritation parameter:
- erythema score
- Basis:
- animal: 29, 31, 32
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- No effects observed
- Remarks on result:
- other: Additional time point
- Remarks:
- Assessment immediately after application was also made which is recorded as time '0'
- Irritation parameter:
- edema score
- Basis:
- animal: 29, 31, 32
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- No effects observed
- Remarks on result:
- other: Additional time point
- Remarks:
- Assessment immediately after application was also made which is recorded as time '0'
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: 29, 31, 32
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- No effects observed
- Remarks on result:
- other: Additional time point
- Remarks:
- Assessment immediately after application was also made which is recorded as time '0'
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following guidelines:
• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)
• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
Method
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
Results
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.
Conclusion
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Reference
Faint light blue coloured staining was noted at all treated skin sites one hour after patch removal and at one treated skin site at the 24-hour observation. The staining did not affect evaluation of skin responses.
No evidence of skin irritation was noted during the study.
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:
- Experimental Phase: 18 February 2002 to 23 February 2002. Report issue: 13 June 2002.
- 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 (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet & Water: Free access to mains drinking water and food (certified rabbit diet).
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye by gently pulling the lower lid away from the eyeball.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using a numerical evaluation according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 120, 121, 122
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 120, 121, 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal: 120, 121, 122
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal: 120, 121, 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 120
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 120
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- other: 1 h
- Score:
- ca. 8
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- other: 48/72h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 122
- Time point:
- other: 1 h
- Score:
- ca. 8
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- chemosis score
- Basis:
- animal: 120
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 121
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 121
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 122
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 120
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 4
- Other effects:
- No corneal or iridial effects were noted during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a maximum group mean score of 6. 7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following gudielines:
• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Method
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Result
A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
Conclusion
The test material produced a maximum group mean score of 6.7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
Results
Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment. Minimal conjunctival redness was noted in one treated eye at the 24-hour observation.
Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-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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