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EC number: 484-440-2 | CAS number: 502157-74-6
- 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 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.
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:
- The study was performed between 21 January 2004 and 30 January 2004.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Description, Identification and Storage Conditions
Sponsor's identification SBCAT-03
Description white powder
Batch number UK.030622B
Date received 09 October 2003
Storage conditions room temperature in the dark
Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Preparation of Test Material
For the purpose of the study the test material was used as supplied.
The absorption of the test material was not determined. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of2.0 to 3.5 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18 :00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Duration of treatment / exposure:
- One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 g oftest material moistened with 0.5 ml of distilled water. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four 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. See "any other information".
- Number of animals:
- 3
- Details on study design:
- 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:
OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" ( adopted 24 April 2002)
Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation) - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- 4-Hour Exposure Period
The individual scores for erythema/eschar and oedema are given in "Any other information".
Very slight erythema was noted at one treated skin site one hour after patch removal.
Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 24-hour observation.
1-Hour Exposure Period
The individual scores for erythema/eschar and oedema are given in Appendix 1.
No evidence of skin irritation was noted during the study.
3-Minute Exposure Period
The individual scores for erythema/eschar and oedema are given in "Any other information".
No evidence of skin irritation was noted during the study. - 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:
• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion"
( adopted 24 April 2002)
• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three
rabbits produced an isolated incident of very slight erythema one hour after patch removal.
3-minute and I-hour semi-occluded applications of the test material to the intact skin of one rabbit
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.
Reference
Individual Skin Reactions Following 4-Hour Exposure
Skin Reaction | Observation Time | Individual Scores - Rabbit Number and Sex | Total | ||
53 Male | 95 Male | 96 Male | |||
Erythema/Eschar Formation | 1 Hour 24 Hours 48 Hours 72 Hours | 0 0 0 0 | 0 0 0 0 | 1 0 0 0 | (1) 0 (0) 0 |
Oedema Formation | 1 Hour 24 Hours 48 Hours 72 Hours | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | (0) 0 (0) 0 |
Sum of 24 and 72-hour Readings (S): 0 | |||||
Primary Irritation Index (S/6): 0/6 = 0.0 | |||||
Classification: NON-IRRITANT |
Individual Skin Reactions Following 1-Hour and 3-Minute Exposures
Skin Reaction | Observation Time | Individual Scores · Rabbit Number and Sex | |
53 Male | |||
1 -Hour Exposure | 3-Minute Exposure | ||
Erythema/Eschar Formation | 1 Hour 24 Hours 48 Hours 72 Hours | 0 0 0 0 | 0 0 0 0 |
Oedema Formation | 1 Hour 24 Hours 48 Hours 72 Hours | 0 0 0 0 | 0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
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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