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EC number: 226-070-4 | CAS number: 5261-31-4
- 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
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Body weight: 2.7 - 2.8 kg
Room temperature and relative humidity: 19-25°C and 40-60%, respectively
Light period: 12 h light/12 h dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g of test substance paste
- Duration of treatment / exposure:
- 4 h, after which the test sites were washed
- Observation period:
- 72 h; the skin was checked for irritation (erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- Approximately 24 h before the test, the fur was shaved from the dorso-lateral area of the trunk (6 cm x 6 cm). 500 mg of the pulverized test substance were moistened with water and subsequently applied to a hypoallergenic patch (2.5 x 2.5 cm). Patches were held in place with semi-occlusive dressing for 4 h.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of erythema, eschar and oedema or ulcerations, necrosis, and scarring were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404 and EU Method B.4. Female New Zealand White rabbits were exposed for 4 h to 0.5 g of the test substance (paste with water). The test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. The skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h. No signs of skin irritation or corrosion were observed during the study. Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin (Suberg, 1985).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From February 02, 1993 to March 09, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- for some descriptions and examinations; but it did not affect the validity of the study
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Breeder: Interfauna U.K. Ltd.
Acclimatization period: at least 14 d
Body weight: 3.3-3.8 kg
Room temperature and relative humidity: 21 +/- 1.5°C and 40 - 70%, respectively
Light period: 12 h light/12 h dark
Diet and water: standard diet "Ssniff K4" and tap water, ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h (After 4 h, the exposed skin was carefully washed with water).
- Observation period:
- 14 d with Draize scoring after 1, 24, 48, 72 h and 7 and 14 d
- Number of animals:
- 3
- Details on study design:
- Approximately 24 h before the test, the fur was shaved from the dorso-lateral area of the trunk (6 cm x 6 cm). 500 mg of the pulverized test substance were moistened with deionized water and subsequently applied to a hypoallergenic patch. Patches were held in place with semi-occlusive dressing for 4 h. The treated skin area was approx. 6 cm2 in size.
- Irritation parameter:
- erythema score
- Remarks:
- due to the orange staining of the treated skin, evaluation of reddening was not possible
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Evaluation of the erythema of the skin was not possible during the first 72 h due to the intense coloration by the test substance. Nevertheless, no other inflammatory signs (eschar and oedema formation) became apparent within this period and no irritant effects were observed after 72 h.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404, in compliance with GLP. Female New-Zealand White rabbits were exposed for 4 h to 500 mg of test substance pulverized on a patch. The test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. The skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 1, 24, 48, 72 h and 7 and 14 d. No signs of skin irritation or corrosion were observed during the study. Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin (Krötlinger, 1993).
- 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:
- supporting study
- Study period:
- 1985
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd Huntingdon, UK
- Age at study initiation: -
- Weight at study initiation: 3.0 - 3.1 kg
- Housing: single in standard cages
- Diet (ad libitum): Ssniff K 4
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Nov 1985 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µL finely powdered
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After gently pulling the lower lid away from the eyeball, a volume of 100 µL of the pulverized test substance was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with physiological saline.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritant to rabbit eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 405 and EU Method B.5. Male New-Zealand White rabbits were exposed to the test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µL of pulverized test substance was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline. Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7 d. In parallel, the opacity of the aqueous humour was also assessed for potential epithelial damage. Two of the three rabbits exhibited positive indications (scores of 1) of irritation i.e. very slight redness of the conjunctiva after 24 h, which were fully reversible within 48 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Suberg, 1985).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 02, 1993 to March 09, 1993
- 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:
- yes
- Remarks:
- for some descriptions and examinations; but it did not affect the validity of the study
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Breeder: Interfauna U.K. Ltd.
Acclimatization period: at least 14 d
Body weight: 3.1-3.5 kg
Room temperature and relative humidity: 21 +/- 1.5°C and 40 - 70%, respectively
Light period: 12 h light/12 h dark
Diet and water: standard diet "Ssniff K4" and tap water, ad libitum - Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- approx. 68 mg (in 100 µL)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After gently pulling the lower lid away from the eyeball, a volume of 100 µL of the pulverized test substance (equivalent to approx. 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after application of the test substance the treated eye was rinsed with normal saline.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritating to rabbit eye.
- Executive summary:
A study was conducted to determine the irritation potential of the test substance according to OECD Guideline 405, in compliance with GLP. Female New Zealand White rabbits were exposed to the test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µL of pulverized test substance (equivalent to approximately 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline. Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7 d. In parallel, the opacity of the aqueous humour (McDonald and Shadduck method) was also assessed for potential epithelial damage. The three rabbits exhibited positive indications (scores between 1 and 2) of irritation i.e. slight reactions (redness and swelling) of the mucous membranes, which were fully reversible within 7 d. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Krötlinger, 1993).
- 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:
A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404 and EU Method B.4. Female New Zealand White rabbits were exposed for 4 h to 0.5 g of the test substance (paste with water). The test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. The skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h. No signs of skin irritation or corrosion were observed during the study. Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin (Suberg, 1985).
A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404, in compliance with GLP. Female New-Zealand White rabbits were exposed for 4 h to 500 mg of test substance pulverized on a patch. The test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. The skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 1, 24, 48, 72 h and 7 and 14 d. No signs of skin irritation or corrosion were observed during the study. Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin (Krötlinger, 1993).
Eye irritation:
A study was conducted to determine the irritation potential of the test substance according to OECD Guideline 405, in compliance with GLP. Female New Zealand White rabbits were exposed to the test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µL of pulverized test substance (equivalent to approximately 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline. Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7 and 14 d. In parallel, the opacity of the aqueous humour (McDonald and Shadduck method) was also assessed for potential epithelial damage. The three rabbits exhibited positive indications (scores between 1 and 2) of irritation i.e. slight reactions (redness and swelling) of the mucous membranes, which were fully reversible within 7 d. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Krötlinger, 1993).
A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 405 and EU Method B.5. Male New-Zealand White rabbits were exposed to the test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µL of pulverized test substance was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline. Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7, 14 and 21 d. In parallel, the opacity of the aqueous humour was also assessed for potential epithelial damage. Two of the three rabbits exhibited positive indications (scores of 1) of irritation i.e. very slight redness of the conjunctiva after 24 h, which were fully reversible within 48 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Suberg, 1985).
Justification for classification or non-classification
The results of the above studies do not trigger a classification for skin and eye irritation according to CLP (EC 1272/2008) criteria.
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