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EC number: 217-588-1 | CAS number: 1897-45-6
- 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, New-Zealand White rabbit, OECD 404, Johnson 2000
- Eye irritation: corrosive, male/female, New-Zealand White rabbit, no guideline, Major 1977
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:
- 20 Dec 1999 to 16 Jan 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 2519 to 2976 g
- Housing: The rabbits were housed individually in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): A minimum of 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Dec 1999, To: 16 Jan 2000 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- (deionised)
- Controls:
- no
- Amount / concentration applied:
- VEHICLE
- Amount applied: 0.5 to 0.6 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 3 males
- Details on study design:
- DOSE ADMINISTRATION
On the day prior to application of the test substance, the hair was removed with a pair of veterinary clippers from an area approximately 7 cm x 13 cm on the left flank of each animal. The test substance (approximately 500 mg) was moistened to a dry paste with a small amount (0.5 - 0.6 mL) of deionised water to allow good skin contact and, using a metal spatula, was applied to the test site (approximate size 2.5 cm x 2.5 cm) on the left flank of each rabbit. The treated area was covered with a piece of 4-ply surgical gauze (approximate size 2.5 cm x 2.5 cm), which was secured by two strips of surgical tape (approximate size 1 cm x 8 cm). This was covered by a piece of impermeable rubber sheeting (approximate size 35 cm x 13 cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape.
The dressings were left in position for approximately four hours. After this time each dressing was carefully cut (using blunt-tipped scissors), removed and discarded. The application site was gently cleansed free of any residual test substance using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper. The application site was identified using a black waterproof marker-pen.
CLINICAL OBSERVATIONS
Prior to the start of the study, all rabbits were examined to ensure that they were physically normal and exhibited normal activity. Throughout the study, the animals were observed daily for general signs of well-being. All animals were removed from the study at the end of the observation period.
IRRITATION RESPONSE
The Draize scale (see "Any other information on materials and methods incl. tables) was used to assess the degree of erythema and oedema at the application sites approximately 1 hour and 1, 2 and 3 days after removal of the dressings and then at intervals for up to 10 days. Any other signs of skin irritation were also noted.
BODY WEIGHTS
The body weight of each animal was recorded at the start of the study. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Very slight erythema was seen in two animals for 1 hour or 5 days, and very slight to moderate/severe erythema was seen in one animal for 7 days. Very slight oedema was seen in one animal for 2 days and very slight to slight oedema was seen in another animal for 3 days. Additional signs of irritation comprised desquamation, thickening, scabbing and wrinkling. All signs of irritation had completely resolved 10 days after application.
- Other effects:
- There were no signs of ill-health in any animal during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study the test substance is considered to be a mild irritant following a single four-hour application to rabbit skin, however not sufficient for classification under CLP.
- Executive summary:
The skin irritation potential of the test substance was determined in vivo according to the OECD 404 test guideline and GLP principles. A group of 3 male rabbits received a single four-hour application of 500 mg test substance to the shorn flank. The animals were assessed for up to 10 days for any signs of skin irritation.
Very slight erythema was seen in two animals for 1 hour or 5 days, and very slight to moderate/severe erythema was seen in one animal for 7 days. Very slight oedema was seen in one animal for 2 days and very slight to slight oedema was seen in another animal for 3 days. Additional signs of irritation comprised desquamation, thickening, scabbing and wrinkling. All signs of irritation had completely resolved 10 days after application.
In conclusion, the test substance is considered to be a mild irritant following a single four-hour application to rabbit skin, however not sufficient for classification under CLP.
Reference
Table 1. Individual and mean skin irritation scores according to the Draize scheme
Time |
Erythema |
Oedema |
||||
Animal number |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
after 1 hour |
1 |
1 |
2 |
0 |
0 |
1 |
after 24 hours |
0 |
1 |
2 |
0 |
1 |
2 |
after 48 hours |
0 |
1t |
3tw |
0 |
1 |
2 |
after 72 hours |
0 |
1t |
2ts |
0 |
0 |
1 |
mean score 24-72 h |
0 |
1.0 |
2.3 |
0 |
0.7 |
1.7 |
after 4 days |
- |
1dt |
2ts |
- |
0 |
0 |
after 5 days |
- |
1d |
2dts |
- |
0 |
0 |
after 7 days |
- |
0d |
1dt |
- |
0 |
0 |
after 10 days |
- |
0 |
0 |
- |
0 |
0 |
- Animal removed from study, d desquamation, t thickening, s scabbing, w wrinkling
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:
- 9 Sep 1977 to 16 Oct 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2002 to 2215 g
- Housing: The rabbits were individually housed in metal metabolism cages in temperature and humidity controlled quarters.
- Diet: Ad libitum
- Water: Ad libitum
IN-LIFE DATES: From: 9 Sep 1977 To: 16 Oct 1977 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 24, 48, and 72 hours, and on days 7 and 14
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3, 4, 6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Marked chemosis precluded observations for corneal and iridal irritation. Maximum score used due to marked chemosis which precluded a definitive score.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3, 4, 6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days (7 days for animal 3 and 4)
- Remarks on result:
- other: Marked chemosis precluded observations for corneal and iridal irritation. Maximum score used due to marked chemosis which precluded a definitive score.
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 1, 2, 4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 5, 6
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- The test substance elicited ocular irritation in all six rabbits. Corneal opacities were observed in all eyes at all observation intervals with the exception of five out of six corneas at 24 hours and four out of six corneas at 48 hours which could not be observed due to severe chemosis. Pannus was observed in two out of six eyes at day 7. Vascularization of the corneal surface was noted in five out of six eyes at day 14. Peeling of the corneal epithelium was observed in all rabbits. Dendritic vascularization was noted in two out of six eyes at day 7. The sodium fluorescein dye examination confirmed the occurrence of corneal damage in all rabbits at all observation intervals.
Iritis (iris still reacting to light) was observed in all six eyes. The iris of five eyes at 24 hours, four eyes at 48 hours and one eye at 72 hours could not be observed due to severe chemosis. Iritis was observed in four out of six eyes on day 14.
Conjunctival irritation (redness, chemosis, discharge and blanching) was observed in all rabbits at all observation intervals. Petite conjunctival haemorrhages were observed in all rabbits through day 7 and persisted to day 14 in one rabbit eye.
The maximum mean total Draize score was 99.9 observed at 24 hours. The maximum individual total Draize score was 108.0 observed in three rabbits at 24 hours. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A dose of 0.1 mg test substance produced corneal opacities, pannus, vascularization of the corneal surface, peeling of the corneal epithelium, dendritic vascularization, iritis, conjunctival irritation and petite conjunctival haemorrhages when instilled into the eyes of albino rabbits, Corneal opacity persisted through day 14 in all six rabbits tested.
- Executive summary:
The eye irritation produced by a single application of the test material was assessed in a primary eye irritation study in New Zealand White rabbits (no guideline, GLP). A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions. The test substance elicited ocular irritation in all six rabbits. Corneal opacities were observed in all eyes at all observation intervals with the exception of five out of six corneas at 24 hours and four out of six corneas at 48 hours which could not be observed due to severe chemosis. Pannus was observed in two out of six eyes at day 7. Vascularization of the corneal surface was noted in five out of six eyes at day 14. Peeling of the corneal epithelium was observed in all rabbits. Dendritic vascularization was noted in two out of six eyes at day 7. The sodium fluorescein dye examination confirmed the occurrence of corneal damage in all rabbits at all observation intervals. Iritis (iris still reacting to light) was observed in all six eyes. The iris of five eyes at 24 hours, four eyes at 48 hours and one eye at 72 hours could not be observed due to severe chemosis. Iritis was observed in four out of six eyes on day 14. Conjunctival irritation (redness, chemosis, discharge and blanching) was observed in all rabbits at all observation intervals. Petite conjunctival haemorrhages were observed in all rabbits through day 7 and persisted to day 14 in one rabbit eye.
In conclusion, the test substance produced corneal opacities, pannus, vascularization of the corneal surface, peeling of the corneal epithelium, dendritic vascularization, iritis, conjunctival irritation and petite conjunctival haemorrhages when instilled into the eyes of albino rabbits, Corneal opacity persisted through day 14 in all six rabbits tested.
Reference
Table 1. results for individual animals
Scores observed after |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
||
Cornea/opacity |
*,2,*,*,*,* |
* ,*, 3,*,*,* |
2,4,2,3,4,3½ |
4,4,4,4,4,4 |
3,4,4,4,4,4 |
||
Iris |
*,0,*,*,*,* |
*,0,1,*,*,* |
2,2,1,*,1,* |
2,2,1,2,1,2 |
0,2,1,2,0,2 |
||
Conjunctiva redness |
2,2,2,2,2,2 |
1½,1½,1,2,2,2 |
2,1,1½,2,2,2 |
1½,1,2,2½,2,2 |
½,1,1,1½,1,1 |
||
Conjunctiva chemosis |
4,4,4,4,4,4 |
4,4,4,4,4,4 |
4,4,4,4,3,4 |
1½,4,1½,4,1½,4 |
1½,2,1½,1½,1½,2 |
||
Conjunctiva discharge |
3,3,3,2,3,2 |
3,2,1½,1,1½,2 |
3,2,2,2,1,2 |
2,2,2,2,1,2 |
0,1,2,1,1,1 |
* Marked chemosis precluded these observations
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
The skin irritation potential of the test substance was determined in vivo according to the OECD 404 test guideline and GLP principles. A group of 3 male rabbits received a single four-hour application of 500 mg test substance to the shorn flank. The animals were assessed for up to 10 days for any signs of skin irritation.
Very slight erythema was seen in two animals for 1 hour or 5 days, and very slight to moderate/severe erythema was seen in one animal for 7 days. Very slight oedema was seen in one animal for 2 days and very slight to slight oedema was seen in another animal for 3 days. Additional signs of irritation comprised desquamation, thickening, scabbing and wrinkling. All signs of irritation had completely resolved 10 days after application.
In conclusion, the test substance is considered to be a mild irritant following a single four-hour application to rabbit skin, however not sufficient for classification under CLP.
Eye irritation/corrosion
The eye irritation produced by a single application of the test material was assessed in a primary eye irritation study in New Zealand White rabbits (no guideline, GLP). A dose of 0.1 mg of test substance was instilled into one eye of each of three male and three female New Zealand White rabbits. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The eyes were examined and scored at 24, 48, and 72 hours, and on days 7 and 14 according to a modified Draize system. A sodium fluorescein dye examination was conducted at 72 hours and on days 7 and 14 in order to detect potential corneal lesions. The test substance elicited ocular irritation in all six rabbits. Corneal opacities were observed in all eyes at all observation intervals with the exception of five out of six corneas at 24 hours and four out of six corneas at 48 hours which could not be observed due to severe chemosis. Pannus was observed in two out of six eyes at day 7. Vascularization of the corneal surface was noted in five out of six eyes at day 14. Peeling of the corneal epithelium was observed in all rabbits. Dendritic vascularization was noted in two out of six eyes at day 7. The sodium fluorescein dye examination confirmed the occurrence of corneal damage in all rabbits at all observation intervals. Iritis (iris still reacting to light) was observed in all six eyes. The iris of five eyes at 24 hours, four eyes at 48 hours and one eye at 72 hours could not be observed due to severe chemosis. Iritis was observed in four out of six eyes on day 14. Conjunctival irritation (redness, chemosis, discharge and blanching) was observed in all rabbits at all observation intervals. Petite conjunctival haemorrhages were observed in all rabbits through day 7 and persisted to day 14 in one rabbit eye.
In conclusion, the test substance produced corneal opacities, pannus, vascularization of the corneal surface, peeling of the corneal epithelium, dendritic vascularization, iritis, conjunctival irritation and petite conjunctival haemorrhages when instilled into the eyes of albino rabbits, Corneal opacity persisted through day 14 in all six rabbits tested.
Respiratory irritation
In an acute inhalation toxicity study the test substance was administered at concentrations of 0.08, 0.14, 0.21 mg/L and dose related mortalities occurred at all dose levels tested. There was evidence of respiratory tract irritancy, at all dose levels including macroscopic pathology in decedents. Clinical signs observed at all concentrations of the test substance during the 4-hour exposure period, were consistent with inhalation of an irritant aerosol, including partial closing of eyes, wetness around the eyes, exaggerated respiratory movements and restless behaviour. Gasping was observed in rats exposed at 0.14 or 0.21 mg/L. Clinical signs following exposure included exaggerated respiratory movements and discharge from the eyes. Deaths as a result of exposure occurred on days 0-2. Recovery from the effects of exposure was evident from day 4 and the majority of surviving rats had recovered by day 9. Typically, the rats that died showed congestion of the lungs. There were no macroscopic abnormalities in rats that survived until scheduled termination.
Justification for classification or non-classification
Based on the available information, classification for skin is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
Based on the available information, the test substance is classified for Eye damage category 1, H318: causes serious eye damage in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
Based on the available information, the test substance is classified for STOT-SE Cat. 3, H335: May cause respiratory irritation in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
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