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EC number: 276-558-6 | CAS number: 72275-69-5
- 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 is not irritating for intact and abraded rabbit skin.
The substance is not irritating for rabbit eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 29, 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- other: water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
10g. of the test compound was mixed with 12 ml. of water to make a solution of 15ml. 0.75ml of which was applied to each test site on a 2.5 cm. square gauze pad. - Duration of treatment / exposure:
- The gauze patches were removed 24 hours after the application.
- Observation period:
- The reaction of the skin was appraised upon removal and 72 hours after it.
- Number of animals:
- 3 males/3 females
- Details on study design:
- TEST SITE
- Area of exposure: Two test sites lateral to the mid line of the back were used on each rabbit
- % coverage: 10 % of the total body surface.
- Type of wrap if used: 0.75ml of test compound was applied to each test site on a 2.5 cm. square gauze pad. These were 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 strips of "Sleek" in order to retain the test substance in close contact with the skin.
SCORING SYSTEM: Draize et al. - Irritation parameter:
- erythema score
- Basis:
- animal: 11, 13, 15, 12, 16
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 12
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 14
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 16
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- other: Not classified
- Remarks:
- According to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- The substance is not irritating for skin rabbit.
- Executive summary:
The substance has been tested for skin irritation/corrosion according to The guideline "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965). 6 Healthy New Zealand White rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial. 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. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. 10g of the test compound was mixed with 12 ml of water to make a
solution of 15 ml. 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.
Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours. There was no marked difference in the reactions between abraded and intact sites.. The substance is not irritating for skin rabbit according to the CLP Regulation (EC n. 1272/2008).
Reference
Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours.
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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 25, 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- Deviations:
- yes
- Remarks:
- no data
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly, bred on the premises and maintained under a semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- single injection
- Observation period (in vivo):
- The rabbits were examined 1, 24, 48, 72 hours and 6 days after application
- Number of animals or in vitro replicates:
- Six rabbits (3 ♂ and 3 ♀)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):yes, after 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Time after start of exposure: 30 seconds - Irritation parameter:
- conjunctivae score
- Basis:
- animal: 11
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 12
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 13
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 14
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 15
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 16
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 11, 12, 13
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 14, 15, 16
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- other: Not classified
- Remarks:
- According to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- The substance is not irritating for rabbit eye.
- Executive summary:
The substance has been tested for eye irritation according to The guideline "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial. The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. 100 mg. of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held
closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was
considered necessary.
A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 48 hours. The substance is not irritating according to the CLP Regulation (EC n. 1272/2008).
Reference
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
According to the CLP Regulation (EC 1272/2008), skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
The key study shows a very low interaction between the substance and the skin rabbit, the values of erythema and oedema with intact skin are below the trigger values for classification, therefore no classification is warranted according to the CLP Regulation (EC n. 1272/2008).
According to the CLP Regulation (EC n. 1272/2008) eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
Under the test condition the substance does not produce ocular effects above the trigger value, therefore no classification is warranted according to the CLP Regulation (EC n. 1272/2008).
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