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EC number: 225-076-4 | CAS number: 4645-32-3
- 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: The test matarial was not irritating to the rabbits' skin under the test conditions chosen.
Eye: The test matarial was not irritating to the rabbits' eye under the test conditions chosen.
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:
- 18 September 1984 and 21 September 1984
- 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:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: individually
- Diet: ad libitum (deionised chlorinated water)
- Water: ad libitum (Altromin)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- SOURCE ANIMAL
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: individually
- Diet: ad libitum (deionised chlorinated water)
- Water: ad libitum (Altromin) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 - 60 min, 24 h, 48 h and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: patch containing the substance covered with a semi-occlusive bandage
OBSERVATION TIME POINTS
30 - 60 min, 24 h, 48 h and 72 h
SCORING SYSTEM:
- Method of calculation: according to Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Animal 1 and 2 showed dry and demure skin after 24 h and 48 h of the application as well as brown, small-area discolorations of the skin after 48 h of the test item application.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not considered to be irritating to rabbits' skin in a study according to OEC TG 404.
- Executive summary:
The test item was examined for skin irritation properties in a study with 3 albino New Zealand White rabbits according to OECD TG 404. The test material was applied to the shaved intact skin of rabbits as a single dose of 0.5 mL and covered with a semi-occlusive dressing. The irritation symptoms were examined at 30 – 60 min, 24, 48 and 72 hours after the patch removal. In all animals very slight erythema (score 1) were recorded 30 – 60 min and 24 hours after patch removal. Two animals showed also very slight erythema 48 hours after patch removal. All animals were free of irritation symptoms (erythema) 72 hours after patch removal. Thus, the study was terminated after 72 hours. No oedema were observed in any animal and at any time pont.
The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.70, 0.70 and 0.30 and 0.00, 0.00 and 0.00 respectively.The observed symptoms were evaluated as fully reversible alterations.
Thus, the test item is not considered to be irritating to rabbits’ skin.
- 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
- Study period:
- 25 September 1984 and 28 September 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- 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: HOECHST AG, Kastengrund
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123)
- Water: ad libitum (deionised, chlorated water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- - 1 hour after application: Animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally.
- 24 hours after application: Two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.
- 72 hours after application: All animals were symptom-free. - Other effects:
- - Ophthalmoscopic findings: none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not considered to be irritanting to rabbits' eye according to OECD TG 405.
- Executive summary:
The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application.
One hour after application animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally. 24 hours after application two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.
All animals were symptom-free 72 hours after application.
For animal 1 and 2, the mean scores (considering readings at 24, 48 and 72 hours after test item application) were 0 for cornea opacity, 0 for iris, 0 for conjunctivae redness and 0 for chemosis. For animal 3, the mean scores were 0.7 for corneal opacity, 0.7 for iris, 1.3 for conjunctivae redness and 1.0 for chemosis. Therefore, the test item is not considered to be irritating to rabbits’ eye.
- 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:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
The test item was examined for skin irritation properties in a study with 3 albino New Zealand White rabbits according to OECD TG 404. The test material was applied to the shaved intact skin of rabbits as a single dose of 0.5 mL and covered with a semi-occlusive dressing. The irritation symptoms were examined at 30 – 60 min, 24, 48 and 72 hours after the patch removal. In all animals very slight erythema (score 1) were recorded 30 – 60 min and 24 hours after patch removal. Two animals showed also very slight erythema 48 hours after patch removal. All animals were free of irritation symptoms (erythema) 72 hours after patch removal. Thus, the study was terminated after 72 hours. No oedema were observed in any animal and at any time pont.
The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.70, 0.70 and 0.30 and 0.00, 0.00 and 0.00 respectively.The observed symptoms were evaluated as fully reversible alterations.
Thus, the test item is not considered to be irritating to rabbits’ skin.
Eye irritation/corrosion
The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application.
One hour after application animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally. 24 hours after application two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.
All animals were symptom-free 72 hours after application.
For animal 1 and 2, the mean scores (considering readings at 24, 48 and 72 hours after test item application) were 0 for cornea opacity, 0 for iris, 0 for conjunctivae redness and 0 for chemosis. For animal 3, the mean scores were 0.7 for corneal opacity, 0.7 for iris, 1.3 for conjunctivae redness and 1.0 for chemosis. Therefore, the test item is not considered to be irritating to rabbits’ eye.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Based on the available experimental data, the substance is not considered to be classified for skin irritation or eye irritation under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.
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