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EC number: 632-619-2 | CAS number: 881685-58-1
- 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 rabbits, according to OECD TG 404, Matting 2014
- Eye irritation: not irritating, male rabbits, according to OECD TG 405, Matting 2014
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:
- 21 Jan 2014 to 26 Jan 2014
- 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:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: ~11 weeks
- Weight at study initiation: 2668 g – 2988 g
- Housing: Animals were housed individually in AAALAC approved metal wire rabbit cages. Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17.7 – 21.7 °C
- Humidity: 23 – 58 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12/12 hours light/dark
IN-LIFE DATES: From: 21 Jan 2014 To: 26 Jan 2014 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of the test material - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- PRE-STUDY EXAMINATION
- The test was performed on 3 male rabbits, checked for normal skin conditions.
TEST SITE
- Area of exposure: An area of 10 x 10 cm on the back and flanks of the rabbits was clipped with an electric clipper 24 hours before the treatment.
- Type of wrap if used: A surgical gauze pad (ca. 2.5 x 2.5 cm) was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was than wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was then removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS : 1, 24, 48 72 hours after the end of exposure
SCORING SYSTEM:
- Method of calculation: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 which was based on the Draize scoring system. For criteria, see 'Any other information on materials and methods incl. tables'.
OTHER OBSERVATIONS
- Clinical signs, including viability/mortality, were recorded daily from the day of application of the animals to the termination of the test.
- Body weights were recorded on the day of application and the end of the observation period. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- The primary irritation index was 0.00 (out of a maximum score of 8.0). No corrosive effects were noted on the treated skin of any animal at any of the observation intervals. No local dermal signs were observed in the treated animals throughout the study.
- Other effects:
- CLINICAL OBSERVATIONS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.
BODY WEIGHT
The body weights of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test material did not result in any signs of skin irritation.
- Executive summary:
Three young adult male New Zealand White rabbits were treated by topical, semi-occlusive application of 0.5 g test material to their intact shaved flanks in a study according to OECD TG 404 and GLP principles. The test material was moistened with water to ensure good skin contact. The duration of treatment was 4 hours. The scoring of skin reactions was performed at 1, 24, 48 and 72 hours after removal of the dressing. The primary irritation index (P.I.I.) was calculated.
The mean average erythema and oedema scores of all animals over 24, 48 and 72 hours were 0. The P.I.I was 0. No local dermal signs were observed in the treated animals throughout the study. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in any signs of skin irritation.
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:
- 29 Jan 2014 to 05 Feb 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 3146 – 3169 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17.3 – 21.7 °C
- Humidity: 24 – 58 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12 hours daily from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 29 Jan 2014 To: 05 Feb 2014 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g of the test material - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PRE-STUDY EXAMINATION
- The pH of the test material was measured as pH 4.0, permitting the test material to be used in the animal studies.
- The test was performed on 3 male rabbits. Before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect.
- Sixty minutes prior to test material application, a systemic opiate analgesic was administered by subcutaneous injection under direct Veterinary supervision. Repeat injections were given on the first day as appropriate to maintain an adequate level of analgesia. Five minutes prior to test material application, a topical ocular anaesthetic was applied to each eye (including the control eye) to ensure direct comparison of any ocular observations. Eight hours after test material application, a systemic opiate analgesic and a nonsteroidal anti-inflammatory drug (NSAID) were administered by subcutaneous injection under direct Veterinary supervision. The systemic opiate analgesic was again injected ~12 hours after the post-treatment analgesic and then every 12 hours, and NSAID injected every 24 hours, until eye scores were zero.
APPLICATION
The test material was placed in the conjunctival sac of the left eye of animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for at least one second in order to prevent loss of the material.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with physiological saline solution at the first observation time point at 1 hour after the application of test item on the all animals as the irritation scores were greater than 1.
- Time after start of exposure: 1 hour
OBSERVATION TIME POINTS
Approximately 1, 24, 48 72 hours after the end of exposure. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48, 72 hours after treatment in all animals. All rabbits were examined for distress at least twice daily, with observations at least 6 hours apart.
SCORING SYSTEM:
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012). For criteria, see 'Any other information on materials and methods incl. tables'.
TOOL USED TO ASSESS SCORE: fluorescein
OTHER OBSERVATIONS
- Individual body weight was recorded on the day of treatment and before euthanasia. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- 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
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- - Initial Pain Reaction/ Pain Reaction (IPR/PR) was not observed.
- Conjunctival redness (score 2), chemosis (score 1) and discharge (score 1 or 2) were seen in all rabbits at 1 hour after treatment. Conjunctival redness (score 1) was seen in all rabbits at 24 hours after treatment.
- All symptoms had fully reversed in all animals after 48 hours.
- Fluorescein staining was negative in all animals at 24, 48 and 72 hours after instillation.
- The control eyes were symptom-free during the study. - Other effects:
- OTHER EFFECTS
- The body weights of all rabbits were considered to be within the normal range of variability.
- No clinical signs of systemic toxicity were observed in any animals in this study.
- No mortality occurred in this study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test material did not result in signs of eye irritation.
- Executive summary:
The test material was administered as an installation of a single dose of 0.1 g into the conjunctival sac of the left eye of 3 adult male New Zealand White rabbits in a study according to OECD TG 405 and GLP principles. The untreated right eye served as the control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test material installation in all animals. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48 and 72 hours after the treatment in all animals. Results obtained from these three animals were used to classify the test item for irritation potential.
Initial Pain Reaction/Pain reaction (IPR/PR) was not observed. The average cornea opacity, iritis and chemosis score of all three animals over 24, 48 and 72 hours was 0. The average conjunctivae score of all three animals over 24, 48 and 72 hours was 0.33. All symptoms had fully reversed in all animals after 48 hours. Fluorescein staining was negative in all animals at 24, 48 and 72 hours after instillation. The control eye of animals was symptom-free during the study. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in signs of eye irritation.
Reference
Table 1. Individual Draize Scores and Individual Total Scores* for Ocular Irritation.
Rabbit Number |
#1 |
#2 |
#3 |
|||||||||
IPR |
0 |
0 |
0 |
|||||||||
PR |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Time after treatment (hour) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
Degree of Opacity (E) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area involved (F) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris (D) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
Redness (A) |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Chemosis (B) |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Discharge (C) |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
*Score (A+B+C) x 2 |
8 |
2 |
0 |
0 |
10 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
*Total Score |
8 |
2 |
0 |
0 |
10 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
* Kay J H and Calandra J C (1962)
Table 2. Individual body weights and body weight changes.
Rabbit Number |
Body weight before treatment (g) |
Body weight after treatment (g) |
Body weight change (g) |
#1 |
3169 |
3197 |
28 |
#2 |
3161 |
3209 |
48 |
#3 |
3146 |
3210 |
64 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
All available data was assessed and the studies representing the worst-case effects were included as key studies. Other studies are included as supporting information. The in vitro data requirements were waived based on the availability of adequate in vivo data. Dosing with the test material in rabbits did not result in any signs of skin or eye irritation. The key studies are considered to be worst-case and were selected for the CSA.
Skin irritation
Two in vivo skin irritation/corrosion studies in rabbits are available. The key study was performed according to OECD TG 404 under GLP. Three young adult male New Zealand White rabbits were treated by topical, semi-occlusive application of 0.5 g test material to their intact shaved. The test material was moistened with water to ensure good skin contact. The duration of treatment was 4 hours. The scoring of skin reactions was performed at 1, 24, 48 and 72 hours after removal of the dressing using the Draize scoring scheme. In addition, the primary irritation index (P.I.I.) was calculated.
The mean average erythema and oedema scores of all animals over 24, 48 and 72 hours were 0. The P.I.I was 0. No local dermal signs were observed in the treated animals throughout the study. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in any signs of skin irritation.
The other study was also performed according to OECD TG 404 under GLP (Ott 2006). In this study, semi-occlusive application of the test material did not results in any signs of irritation.
Eye irritation
Three in vivo eye irritation/corrosion studies in rabbits are available. The key study was performed according to OECD TG 405 under GLP (Matting 2014). The test material was administered as an installation of a single dose of 0.1 g into the conjunctival sac of the left eye of 3 adult male New Zealand White rabbits. The untreated right eye served as the control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test material installation in all animals. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48 and 72 hours after the treatment in all animals. Results obtained from these three animals were used to classify the test item for irritation potential.
Initial Pain Reaction/Pain reaction (IPR/PR) was not observed. The average cornea opacity, iritis and chemosis score of all three animals over 24, 48 and 72 hours was 0. The average conjunctivae score of all three animals over 24, 48 and 72 hours was 0.33. All symptoms had fully reversed in all animals after 48 hours. Fluorescein staining was negative in all animals at 24, 48 and 72 hours after instillation. The control eye of animals was symptom-free during the study. No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test material did not result in signs of eye irritation.
The other studies were also conducted in rabbits and performed according to OECD TG 405 under GLP (Sieber 2012 and TalviOja 2007). In the study by Sieber, effects were minor and reversible within 24 hours. Therefore, the test substance was not considered to be irritating to the eye. In the study by TalviOja, minor signs of conjunctivae redness were reversible within seven days and chemosis within two days. The severity of these effects were not sufficient for classification and therefore the test substance was considered to be not irritating to the eye.
Respiratory irritation
In the acute inhalation toxicity studies there were no indication of respiratory irritation observed in either clinical signs or at necropsy.
Justification for classification or non-classification
Based on the result of the skin irritation and eye irritation studies classification for irritation/ corrosion is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
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