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EC number: 241-734-3 | CAS number: 17741-63-8
- 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 substance has a primary irritation index of 0.4 and is therefore a minimal primary skin irritant in the albino rabbit. In a second skin irritation study, the substance did not exhibit skin irritating properties.
The substance did not show eye irritating properties. In a second eye irritation study, the substance was determined to be a minimal eye irritant.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 3 - 4 months
- Weight at study initiation: male 2.20 kg and female 2.32 kg
- Housing: single
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: sterile filtered water was available at all times
- Acclimation period: one week prior to the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 8:00 - 18:00 hours - Type of coverage:
- occlusive
- Preparation of test site:
- other: left shaved; right shaved+abraded
- Vehicle:
- other: 50% solution of polyethylene glycol and water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 15 mL
- Concentration (if solution): 50% solution of polyethylene glycol and water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males, 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2 test sites of 2.5 cm2
- % coverage: 10%
- Type of wrap if used: Gauze pad covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban"-self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- A very slight to slight oedema was present in 5/6 rabbits 24 hours after application of the compound. All sites were clear by 72 hours.
There was no significant difference between intact and abraded sites. - Interpretation of results:
- GHS criteria not met
Reference
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- After application eye lids were held open for a few seconds instead of closed.
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 10-12 weeks
- Weight at study initiation: male 2.20 kg and female 2.32 kg
- Housing: single
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water was available at all times
- Acclimation period: one week prior to the start of the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 08.00 - 18.00 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Eyes of 3 animals were rinsed 30 seconds after treatment. Eyes of 3 animals were not rinsed.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes of three animals, with warm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 6 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: eyes washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 6 hours
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 days
- Remarks on result:
- other: eyes washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 days
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 6 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 hours
- Remarks on result:
- other: eyes washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 6 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 hours
- Remarks on result:
- other: eyes washed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is a minimal eye irritant in the albino rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a skin irritation test 6 New Zealand White rabbits (3 male, 3 female) were exposed to 0.5 g of the test substance in a 50% solution of polyethylene glycol and water. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded. The application site was covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban"- self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek". After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours. A very slight to slight oedema was present in 5/6 rabbits 24 hours after application of the compound. All sites were clear by 72 hours. There was no significant difference between intact and abraded sites. The primary irritation score was 0.4. The substance is a minimal primary skin irritant in the albino rabbit.
In a skin irritation test 6 Russian breed rabbits (3 male, 3 female) were exposed to 0.5 g of the test substance wetted with tap water. One day before treatment, the flanks of the rabbits were shaved with an electric clipper. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with the test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 7 days. No signs of erythema or oedema were observed up to 7 days after application of the compound. Therefore, under the conditions of this experiment the substance was found to be non irritant when applied to intact and abraded rabbit skin.
In a eye irritation test 6 Russian breed rabbits (3 male, 3 female) received 0.1 g of the test substance into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with physiologic saline about 1 minute after treatment. The reactions were appraised with a slit-lamp after 1 and 6 hours and after 1, 2, 3, 6 and 8 days. The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore the test substance is to be considered as non-irritant to the eye of rabbits.
In a eye irritation test 6 Russian breed rabbits (3 male, 3 female) received 100 mg of the test substance into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held closed for one second. The right eye served as a control. After 30 seconds the treated eyes of three rabbits were each rinsed with warm water for 1 minute after treatment. The rabbits were examined 1, 6, 24, 48 and 72 hours after application. A minimal conjunctival reaction was seen one hour after the application of the compound. Only 2/3 unwashed eyes were still showing a minimal reaction at 24 hours and all were clear by 72 hours.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.
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