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EC number: 230-711-3 | CAS number: 7287-19-6
- 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 irritation: not irritating, male/female, New-Zealand White rabbit, OECD 404, Moore 2004
- Eye irritation: not irritating, male/female, New-Zealand White rabbit, OECD 405, Moore 2004
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:
- 10 Aug 2004 to 13 Aug 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200
- Version / remarks:
- January 29, 1985
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Pelleted Rabbit Chow
Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 Aug 2004 To: 13 Aug 2004 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Five-tenths of a gram of the test substance (1.11 g of the test mixture)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 2 females
- Details on study design:
- PREPARATION AND SELECTION OF ANIMALS
On the day before application, a group of animals was prepared by clipping the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy animals without pre-existing skin irritation were selected for test.
APPLICATION OF TEST SUBSTANCE
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 45% w/w mixture. Five-tenths of a gram of the test substance (1.11 g of the test mixture) was placed on a 1 inch x 1 inch, 4-ply gauze pad and applied to one 6 cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.
EVALUATION OF TEST SITES
individual dose sites were scored according to the Draize scoring system (see Table 1 in 'Any other information on materials and methods incl. tables') at approximately 1, 24, 48, and 72 hours after patch removal.
CAGE SIDE OBSERVATIONS
The animals were observed for signs of gross toxicity and behavioural changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea and coma. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour after patch removal, very slight erythema was noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 24 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study (OECD 404, GLP), the mean erythema and oedema scores of all three animals for the 24/48/72 hours time points were determined to be 0.
- Executive summary:
A primary skin irritation test was conducted with rabbits, in accordance with GLP and OECD guideline 404, to determine the skin irritation potential of the substance after a single topical application. An aliquot of 0.5 g test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours under semi-occlusive conditions. Following exposure, dermal irritation was evaluated by the method of Draize et al.
One hour after patch removal, very slight erythema was noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 24 hours. The mean erythema and oedema scores of all three animals for the time points after 24/48/72 hours were determined to be 0.
Under the conditions of this study, the substance was considered to be not irritating to the skin of rabbits.
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
- Study period:
- 19 Aug 2004 to 22 Aug 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200
- Version / remarks:
- January 28, 1985
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 weeks
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Pelleted Rabbit Chow
- Water: Filtered tap water was supplied ad-libitum by automatic water dispensing system.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19 Aug 2004 To: 22 Aug 2004 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- One-tenth of a millilitre (0.03 grams) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- PREPARATION AND SELECTION OF ANIMALS
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds after instillation of the fluorescein. Using an ultraviolet light source, the eyes were checked for gross abnormalities. Three healthy animals without pre-existing ocular irritation were selected for test.
INSTILLATION
Prior to use, the test substance was ground with a mortar and pestle. One-tenth of a milliliter (0.03 grams) of the test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
OCULAR SCORING
Ocular irritation was evaluated using a high-intensity white light in accordance with Draize et al. (see Table 1 at ‘Any other information on methods and materials incl. tables’) at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure described above was used at 24 hours to verify the absence of corneal damage. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
CAGE SIDE OBERVATIONS
The animals were observed for signs of gross toxicity and behavioural changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea and coma. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #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: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Within the first hour following test substance instillation, “positive” conjunctivitis was observed in all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 48 hours.
- Other effects:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study (OECD 405, GLP), the mean irritation scores for the 24/48/72 hour time points were determined to be 0 for all animals for corneal opacity, iritis and chemosis. The mean irritation scores for the 24/48/72 hour time points for conjunctival redness was determined to be 0.33 for all animals.
- Executive summary:
A primary eye irritation test was conducted with rabbits, in accordance with GLP and OECD guideline 405, to determine the irritation potential of the substance after a single instillation into the eye. An aliquot of 0.1 mL (0.03 grams) test substance was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.
Within the first hour following test substance instillation, “positive” conjunctivitis was observed in all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free from ocular irritation within 48 hours. The mean irritation scores for the time points after 24/48/72 hours were determined to be 0 for all animals for corneal opacity, iritis and chemosis. The mean irritation scores for the time points after 24/48/72 hours for conjunctival redness were determined to be 0.33 for all animals.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
Reference
Table 1. Individual eye irritation scores
|
Rabbit #1 |
Rabbit #2 |
Rabbit #3 |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
|
|||||||||||
A. Opacity |
0 |
0* |
0 |
0 |
0 |
0* |
0 |
0 |
0 |
0* |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
|
|||||||||||
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
|
|||||||||||
A. Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Discharge |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
(A+B+C)x2 |
6 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
6 |
2 |
0 |
0 |
Total |
6 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
6 |
2 |
0 |
0 |
* 2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A primary skin irritation test was conducted with rabbits, in accordance with GLP and OECD guideline 404, to determine the skin irritation potential of the substance after a single topical application. An aliquot of 0.5 g test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours under semi-occlusive dressing. Following exposure, dermal irritation was evaluated by the method of Draize et al. One hour after patch removal, very slight erythema was noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 24 hours. The mean erythema and oedema scores of all three animals for the time points after 24/48/72 hours were determined to be 0. Under the conditions of this study, the substance was considered to be not irritating to the skin of rabbits.
Eye irritation
A primary eye irritation test was conducted with rabbits, in accordance with GLP and OECD guideline 405, to determine the irritation potential of the substance after a single instillation into the eye. An aliquot of 0.1 mL (0.03 grams) test substance was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. Within the first hour following test substance instillation, “positive” conjunctivitis was observed in all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free from ocular irritation within 48 hours. The mean irritation scores for the time points after 24/48/72 hours were determined to be 0 for all animals for corneal opacity, iritis and chemosis. The mean irritation scores for the time points after 24/48/72 hours for conjunctival redness were determined to be 0.33 for all animals. Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
Justification for classification or non-classification
Based on the available information, classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
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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