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EC number: 948-020-7 | 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 test substance was considered to be moderately irritating to the skin of rabbits.
Eye irritation
Under the conditions of the study, the test substance was considered to be moderately irritating to the eye of rabbits. The results indicate no means scores above 1 after 24 hours and fully reversed by 72 hours.
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:
- August 1983 to 19 September 1983
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New England White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: Externally sourced
- Sex: Male
- Weight at study initiation: Ranges from 2.38 to 2.96 Kg
- Housing: All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. Animals were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: The rabbits were provided NIH Animal Feed A (certified) ad libitum
- Water: ad libitum
- Acclimation period: A minimum of 5 days - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- A volume of 0.5 ml of the test article was applied to each of 2 sites per rabbit.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes, 24, 48 and 72 hours
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- Type of wrap if used: Following application, each test site was occluded with a one-inch square gauze patch and Blenderm® tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently wiped with clean gauze.
OBSERVATION TIME POINTS
- 30 minutes after test material removal and the exposure sites were again examined and scored 24, 48 and 72 hours after unwrapping. Any extraordinary findings, dermal or toxicological, were noted. The animals were also observed and scored on days 4, 7, 10 and 14.
SCORING SYSTEM:
- Method of calculation:the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Driaze scale. - Irritation parameter:
- other: Draize scale
- Remarks:
- erythema/eschar and oedema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.11
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance was considered to be moderately irritating to the skin of rabbits.
- Executive summary:
To determine the potential of the test material to cause irritation to the skin a study was conducted in accordance to OECD guidelines under GLP conditions. The study has been given a Klimisch score of 1 and is considered to be a key study. Six male New England White rabbits were treated with 0.5 mL test material/site, 2 sites/rabbit; occlusive coverage for 4 hour treatment. Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. Under the conditions of this study, the test substance was considered to be moderately irritating to the skin of rabbits.
Reference
Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. The test substance was considered to be moderately irritating to the skin of rabbits.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- August 1983
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Sponsor Test Article ID : OD-826, Lot #DU71/2
- Species:
- rabbit
- Strain:
- other: New England White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Externally sourced
- Sex: Female
- Weight at study initiation: Ranged from 2.36 to 2.78 Kg
- Housing: All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: NIH Animal Feed A (certified), ad libitum
- Water: as libitum
- Acclimation period: A minimum of 5 days - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of the test substance
- Duration of treatment / exposure:
- 1 dose / 14 days exposure
- Observation period (in vivo):
- 1, 24, 48 and 72 hours. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
SCORING SYSTEM:
- Draize Scale
TOOL USED TO ASSESS SCORE:
- Sodium fluorescein - Irritation parameter:
- other: Draize Scale
- Remarks:
- Mean Eye Irritation Scores
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 6
- Reversibility:
- not specified
- Irritation parameter:
- other: Draize Scale
- Remarks:
- Mean Eye Irritation Scores
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.7
- Reversibility:
- not specified
- Irritation parameter:
- other: Draize Scale
- Remarks:
- Mean Eye Irritation Scores
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Reversibility:
- not specified
- Irritation parameter:
- other: Draize Scale
- Remarks:
- Mean Eye Irritation Scores
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test substance was considered to be moderately irritating to the eye of rabbits. The results indicate no means scores above 1 after 24 hours and fully reversed by 72 hours.
- Executive summary:
To determine the potential of the test material to cause irritation to the eye a study was conducted in accordance to OECD guidelines under GLP conditions. The study has been given a Klimisch score of 1 and is considered to be a key study. Six female New England White rabbits were treated with 0.1 mL test material in one eye and the other eye remained untreated and this was used as a control. The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at 1, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at 1, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.
Reference
The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at l, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at l, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.
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
Based upon a skin irritation study, the test substance is classified as a skin irritant.
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