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EC number: 203-517-1 | CAS number: 107-74-4
- 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
In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.
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:
- 1972-1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- Four normal, healthy, albino rabbits, weighing 2 - 3.5 kg, were used in this study. The animals had been acclimated to laboratory conditions for at least two weeks prior to being placed on test. Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three cm, longitudinally, over the clipped area of exposure.
The test material, at a level of 5 ml. per kilo, was applied to the clipped intact and abraded skin areas. These areas were covered with a rubber sleeve or dam which fit snuggly around each animal. The animals were then placed in a multiple animal holder and held there for a twenty-four hour period. During this time each test animal was allowed its daily ration of rabbit pellets and water.
Following the twenty-four hour exposure period the rubber sleeves were removed from the test animals and skin reactions recorded. Each animal was thoroughly wiped down and returned to its own metabolism cage to be observed for a fourteen day period. - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 5 mL/kg
- Duration of treatment / exposure:
- 24 h
- Observation period:
- up to 14 days
- Number of animals:
- 4
- Details on study design:
- Single application of 5 mL/kg onto intact and abraded skin, occlusive dressing over 24 hrs, readings at patch removal
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: eschar score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
- Executive summary:
In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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
- 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: DR . K . THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: 3.00-3.38 kg
- Housing: single housing
- Diet (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Water (e.g. ad libitum): KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, (ABOUT 130 G PER ANIMAL PER DAY)
- Acclimatization period: at least 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated eye
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h and 8 d
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h and 8d
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h and 8 d
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Due reversible of conjunctivae redness (score >=2) a classification of Category 2B is justified.
- Executive summary:
Three White New Zealand were subject to a single ocular application of 0.1 mL. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.
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