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EC number: 228-536-2 | CAS number: 6290-17-1
- 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 vivo skin irritation (OECD 404): Not irritating
In vivo eye irritation (OECD 405): Not irritating
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:
- 11 March 2002 - 22 March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An in vivo study was performed at 2002.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Albino rabbits (Chbb:HM)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: stock Chbb:HM(SPF) - Littlerussian, BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: no
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not indicated - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol/Diethylphthalate 1:1
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle.
0.5 mL of the test substance or vehicle was applied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: adhesive Gothaplast tape
REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: 1 hour, 24 hours, 48 hours and 72 hours after termination of exposure.
SCORING SYSTEM: according to the scale shown in table 1 and 2 ('Any other information on materials and methods, incl. tables'). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- 1, 24, 48 and 72 hours after the termination of exposure none of the animals showed skin reactions.
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- According to EU CLP (EC. No. 1272/2008 and its amendments).
- Conclusions:
- Under the experimental conditions described in this report, no skin irritation was observed in rabbits after exposure to the substance.
- Executive summary:
In this study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (EtOH/DEP, vehicle), 1%, 10%, 25%, 50% were tested with vehicle and 100% (v/v) was used undiluted. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant and does not need to be classified for skin irritation according to Regulation (EC) No. 1272/2008 and its amendments.
- 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:
- 8 April 2002 - 12 April 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In vivo information of 2002 is used for the assessment of the eye irritation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- January 1997
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: albino female rabbits of the stock Chbb:GM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: no
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature: 20°C ± 3°C
- Humidity: 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not indicated - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- 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 treatment
- Number of animals or in vitro replicates:
- The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal three more rabbits were included in the study.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
After rinsing with 20 ml 0.9 % sodium chloride solution the eyes were examined again using UVlight to detect possible corneal damage. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- - One hour after the application of the test article all animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal were observed in one animal.
- 24 hours after the application of the test article two animals showed some conjunctival vessels definitely injected and a swelling above normal. Some conjunctival vessels definitely injected were observed in the third animal, whereas the fourth animal did not show any signs of eye irritation.
- 48 and 72 hours after the application of the test article all animals were free of any signs of eye irritation. - Interpretation of results:
- other: Not an eye irritant.
- Remarks:
- In accordance Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- Based on the results of an eye irritation study, performed according to OECD 405 guideline and under GLP, the substance is considered not to be an eye irritant.
- Executive summary:
A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant and does not need to be classified according to Regulation (EC) No. 1272/2008 and its amendments.
- 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)
Additional information
Skin corrosion: the substance is not corrosive in absence of skin and eye irritation.
Skin irritation:
In a study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle were tested. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant.
Eye irritation:
A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant.
Justification for classification or non-classification
Based on the results, the substance does not need to be classified for skin corrosion, skin irritation and eye irritation according to EU CLP (EC no. 1272/2008 and its amendments).
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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