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EC number: 214-686-6 | CAS number: 1185-57-5
- 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
Skin irritation:
The dermal irritation potential of target chemical was assessed in various in-vivo experimental studies.Based on the available studies,it can be concluded that the test chemical is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified''.
Eye irritation:
The ocular irritation potential of target chemical was assessed in various in-vivo experimental studies.Based on the available studies,it can be concluded that the test chemical is unable to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified''.
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:
- comparable to guideline study
- Justification for type of information:
- Data is from experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin following the application of the test article.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Conelli S.n,c., Via Milano. 61 - 28041 ARONA (Novara - Italy) and received on January 7, 1998 (shipping slip No. 00001, dated Itinerary 7. 1998).
- Age at study initiation: 2 - 3 months old
- Weight at study initiation: 2.5 - 2.8kg.
- Fasting period before study:
- Housing: housed in room T05C.
- Diet (e.g. ad libitum): The animals were fed a diet coded "2 RB 15 GLP Certificate" produced by the Charles River ltalia's feed licensec Mucedola S.r.l., Seflimo Milanese. ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±2
- Humidity (%):50%±15
- Air changes (per hr): approximately 20 air changes per hour (filtered on HEPA 99.97%).
- Photoperiod (hrs dark / hrs light): The room was illuminated by artificial lighting with a 12-hour circadian cycle (7 a.m. - 7 p.m.).
IN-LIFE DATES: From: To: March 2- March 5, 1998 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.5 ml/site
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1, 24. 48 and 72 hours after the 4-hour exposure period (all rabbits).
- Number of animals:
- 3 female
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: the trunk
- % coverage: approximately 6 cm2
- Type of wrap if used: The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual substance was removed with water
- Time after start of exposure: 1, 24. 48 and 72 hours after - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 minutes, 1 hour and 4 hours (for single rabbit ) and after 1, 24. 48 and 72 hours (all rabbits)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No changes were seen at any test article application site. No clinical signs, either general or local (at the application sites), were noted in any rabbit.
- Other effects:
- not specified
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test material was considered to be non-irritant when administrated to rabbits by dermal route.
- Executive summary:
An acute dermal irritation study of test chemical was conducted in the female New Zealand White rabbit (3 animals) in accordance with EEC Guidelines (B.4) and OECD Guidelines (404).
0.5 ml of the test article were applied on the intact skin of the trunk to a small area (approximately 6 cm2) of skin. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). At the end of each exposure period, residual substance was removed with water. Adjacent areas of untreated skin of each animal served as control for the test.
Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1, 24. 48 and 72 hours after the 4-hour exposure period (all rabbits). Inspections for mortality and general clinical signs were made once a day.
No changes were seen at any test article application site. No clinical signs, either general or local (at the application sites), were noted in any rabbit. Thus, the test material was considered to be non-irritant when administrated to rabbits by dermal route.
Reference
Table 1:
Grading of Skin Reaction |
1. Erythema and Eschar Formation No erythema....................................................................................... 0 Very slight erythema (barely perceptible)............................................. 1 Well defined erythema........................................................................ 2 Moderate to severe erythema.............................................................3 Severe erythema (beet redness) to slight Eschar formation (injuries in depth)..................................................... 4 Maximum possible = 4
|
2. edema Formation No oedema......................................................................................... 0 Very slight edema (barely perceptible)................................................. 1 Slight edema (edges of area well defined by definite raising)................. 2 Moderate edema (raised approximately 1 mm...................................... 3 Severe edema (raised more than 1 mm and extending Beyond area of exposure)....................................................................4 Maximum possible = 4
|
Evaluation of results: the dermal irritation was evaluated in conjunction with the nature and reversibility or otherwiseofthe responsesobserved. |
RESULTS:
Table 2: Observation of single rabbit
Exposure period: 3 minutes
Erythema And Eschar
Obs. wade at |
42F (animal No.) |
3minutes |
0 |
72 hours |
0 |
Edema
3 minutes |
0 |
72 hours |
0 |
Exposure period: 1hour
ErythemaAnd Eschar
Obs. made at |
42F (animal No.) |
1 hour |
0 |
72 hours |
0 |
Edema
1 hour |
0 |
72 hours |
0 |
Table 3: obervation of all rabbits
Exposure period:4 hours
Erythema And Eschar
Obs. made at |
42F |
46F |
48F |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Edema
Obs. made at |
42F |
46F |
48F |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- other: the OECD [C(81) 30 (final)]
- Principles of method if other than guideline:
- The purpose of the study was to evaluate the acute eye irritation and/or corrosive effects on the eye following the application of the test article.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Conelli S.n,c., Via Milano. 61 - 28041 ARONA (Novara - Italy) and received on January 7,1998 (shipping slip No. 00001, dated Itinerary 7,1998).
- Age at study initiation: 2 - 3 months old
- Weight at study initiation: 2.5 - 2.8 kg.
- Fasting period before study:Not specified
- Housing: housed in room T05C
- Diet (e.g. ad libitum): The animals were fed a diet coded "2 RB 15 GLP Certificate" produced by the Charles River ltalia's feed licensec Mucedola S.r.l., Seflimo Milanese. ad libitum.
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2
- Humidity (%):50% ± 15
- Air changes (per hr): approximately 20 air changes per hour (filtered on HEPA 99.97%).
- Photoperiod (hrs dark / hrs light): The room was illuminated by artificial lighting with a 12-hour circadian cycle (7 a.m. - 7 p.m.).
IN-LIFE DATES: From: To: March 3 - March 6,1998 - Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml / animal
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the test article application.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: the conjunctival sac of the right eye of each animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At 24 hours a washout was performed.
- Time after start of exposure: 1, 24, 48 and 72 hours
SCORING SYSTEM: as mentioned in table 1
TOOL USED TO ASSESS SCORE: After the 24-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
other : Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used. - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed. Negative results were obtained at the fluorescein staining performed 24 hours after the test article application .
- Other effects:
- Neither mortality nor adverse general clinical modifications were seen during the study.
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant when administered to New Zealand White rabbits as a single ocular application.
- Executive summary:
An acute ocular irritation study of test chemical was conducted in the male New Zealand White rabbit (3 animals) in accordance with the OECD [C(81) 30 (final)].
Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.
About 0.1 ml of the test article was placed in the conjunctival sac of the right eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3-4 seconds in order to prevent loss of the material. The other eye (the left eye), remaining untreated, served as control. At 24 hours a washout was performed.
Observations were performed at 1, 24, 48 and 72 hours after the test article application. After the 24-hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution. Inspections for mortality and general clinical signs were made once a day.
Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed.
Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant,when administered to New Zealand White rabbits as a single ocular application.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In different studies, the test chemical has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in-vivo experimental studies conducted in different subjects which have been summarized as below:
An acute dermal irritation study of test chemical was conducted in the female New Zealand White rabbit (3 animals) in accordance with EEC Guidelines (B.4) and OECD Guidelines (404). 0.5 ml of the test article were applied on the intact skin of the trunk to a small area (approximately 6 cm2) of skin. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). At the end of each exposure period, residual substance was removed with water. Adjacent areas of untreated skin of each animal served as control for the test.Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1, 24. 48 and 72 hours after the 4-hour exposure period (all rabbits). Inspections for mortality and general clinical signs were made once a day.No changes were seen at any test article application site. No clinical signs, either general or local (at the application sites), were noted in any rabbit. Thus, the test material was considered to be non-irritant when administrated to rabbits by dermal route.
Moreover in another acute skin irritation study which was performed on rabbits to assess the degree of irritation caused by the test chemical. 6 New Zealand White rabbits were used for the study. Animals are held for 14 days after arrival in the facility but prior to use in tests to ensure that they are healthy. Four intact sites of administration , 2 on each side of rabbits back were assigned a code number:
#1:Test substance
#2: Negative control
#3: Positive control
#4: Vehicle control (if required)
A positive control substance (a known skin irritant, 1 % sodium lauryl sulfate in water) and a negative control (plain gauze patch) were applied to the skin along with the test chemical. Since the test chemical was moistened with physiological saline, a vehicle control patch was also applied along with the test, control patches. This vehicle control patch consists of plain gauze patch moistened with vehicle.Each test or control substance was held in place with a 1 x 1 inch2 12-ply surgical gauze patch. The gauze patch is applied to the appropriate skin site and secured with 1-inch wide strips of Blenderm surgical tape (3M Company, Medical Products Division), at the four edges, leaving the center of the gauze patch non-occluded.0.5-g portion was weighed and placed on the gauze patch prior to application of the patch. The test substance and patch are then placed on the appropriate skin site and secured. The patch is subsequently moistened with 0.5 ml physiological saline.The entire trunk of the animal was covered with an impervious material (Saran Wrap) (Dow Chemical Co., IN) for a 24-hr period of exposure. The Saran Wrap was secured by wrapping several long strips of athletic adhesive tape (Quick Strap Tape, Acme Cotton Products, NY) around the trunk of the animal.A Saf-T-Shield (HAY International, Glendale, CA) collar was fitted and fastened around the neck of each test animal. The collar remains in place for a 24-hr exposure period. The collar prevents the animal from removing the wrapping and patches, while allowing it access to food and water ad libitum. Dermal irritation scores for erythema and edema formation are evaluated by the scale proposed by Draize. If irritation persists for 72 hr post application, dermal irritation scores will be continued until all irritation produced by the substance (test site) resolves or until day 14 post application. Persistent irritation scores are also recorded, as well as the occurrence of eschar (+E) and/or necrosis (+N). The primary dermal irritation index (PDII) was then calculated by dividing the sum of total irritation scores by the number of observations, and classifying the test
substance:
PDII of
0.00 = Non-irritant;
> 0.00-0.50 = negligible irritant;
> 0.50-2.00 = mild irritant;
> 2.00-5.00 = moderate irritant;
> 5.00-8.00 = severe (primary) irritant.
The test chemical when applied onto the intact skin of 6 New Zealand white rabbits at the concentration 0.5 g in 0.5 ml saline produced mild skin irritation effects along with the PDII score was 1.8. Moreover, the study considered two classification system ,i.e. primary dermal irritation (PDI) classifications and the Federal Hazardous Substances Act (FHSA). As the test chemical induced mild skin effects which was not enough to classify the chemical as positive and also considering FHSA classification, the test chemical was considered to be non-irritant to rabbit skin.
All these studies lead to a conclusion that Test chemical is indeed not irritating to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.
Eye Irritation:
In different studies, the test chemical has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in-vivo experimental conducted in rabbits conducted which have been summarized as below:
An acute ocular irritation study of test chemical was conducted in the male New Zealand White rabbit (3 animals) in accordance with the OECD [C(81) 30 (final)]. Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used. About 0.1 ml of the test article was placed in the conjunctival sac of the right eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3-4 seconds in order to prevent loss of the material. The other eye (the left eye), remaining untreated, served as control. At 24 hours a washout was performed. Observations were performed at 1, 24, 48 and 72 hours after the test article application. After the 24-hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution. Inspections for mortality and general clinical signs were made once a day. Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed. Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant,when administered to New Zealand White rabbits as a single ocular application.
Moreover in another ocular irritation study,in which potential of the test chemical was evaluated in rabbits. The study was performed according to Code of Federal Regulations, Title 16: Subchapter C-Federal Hazardous Substances Act. Part 1500.42, Revised January 1, 1981 (test for eye irritants) Guidelines. 9 New Zealand White rabbits were used for the study. The rabbits were acclimatized for 14 days prior to test initiation.One hour prior to instillation of the test substance, both eyes of each of at least 12 rabbits was examined for signs of irritation and corneal defects with a handheld slit lamp (Kowa SL-5). Then all eyes are stained with a 2.0% sodium fluorescein and examined to confirm the absence of corneal lesions. The overall study design uses nine rabbits.The contra lateral eye remained untreated and served as control. The treated eyes of the three rabbits from 9 were irrigated for1min with room temperature tap water using a polyethylene squeeze bottle, starting 20 sec after installation. At least 1 hr after fluorescein staining, the test substance was placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup (conjunctival cul-de-sac) into which the test material was dropped. The eyes are observed for any immediate signs of discomfort after instilling the test substance, with blepharospasm and/or excessive tearing being taken as indications of irritating sensations caused by the test substance. Grading and scoring of ocular irritation are performed in accordance with the standard Draize grades for ocular lesions. The eyes are examined and grades of ocular reactions were recorded at 1 hr, 1, 2, 3, 4, and 7 days after exposure. After all observations were recorded and photographed 1 day after exposure, all corneas are further examined with the aid of sodium fluorescein.The mean Draize scores after 24 hours post-instillation was 0.0. Based on the readings and classification criteria mentioned the test chemical can be considered to be not irritating to eyes.
All these studies lead to a conclusion that Test chemical is indeed not irritating to eye. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical was observed in various studies. The results obtained from these studies indicate that the chemical is not likely to cause skin and eye irritation. Hence, the test chemical can be classified under the category “Not Classified” for skin and eye irritation as per CLP.
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