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EC number: 203-273-6 | CAS number: 105-13-5
- 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
A study was performed to determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the Open Epicutaneous test (OET)
Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.
Based on these observations, the test chemical can be considered to be irritating to skin.
Eye Irritation
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- other: Open Epicutaneous test (OET)
- Principles of method if other than guideline:
- To determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the Open Epicutaneous test (OET)
- GLP compliance:
- not specified
- Species:
- guinea pig
- Strain:
- not specified
- Type of coverage:
- open
- Preparation of test site:
- other: clipped flank
- Vehicle:
- other: acetone
- Controls:
- yes
- Amount / concentration applied:
- 60, 30, 10 and 3 %
- Duration of treatment / exposure:
- 21 days
- Observation period:
- after a single application or after repeated application over 21 successive days
- Number of animals:
- 6-8
- Details on study design:
- One day before starting the induction procedure, the threshold-toxic concentration of the test material is estimated. A single application of 0.025 ml of each test concentration (e.g. 100, 30, 10 and 3%) is simultaneously performed on one of the areas measuring 2cm2 of the flank skin previously clipped and marked with a circular stamp.
The skin reactions are read 24 hours after the application of the test material. The minimal irritant and the maximal non-irritant concentrations are determined by an all-or-none criterion. The minimal irritant concentration is defined as the lowest one causing skin irritation. The maximal non-irritant concentration is defined as the highest one not causing macroscopic skin reactions in any of the animals. The estimation of the threshold concentration (minimal irritating and maximal non-irritating concentrations) is essential for the evaluation of the allergenic capacity of the test material based on the end point determination. - Irritation parameter:
- other: Highest non irritant
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- 3% solution of the substance
- Irritation parameter:
- other: Lowest irritant
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- 10% solution of the substance
- Irritant / corrosive response data:
- Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.
Based on these observations, the test chemical can be considered to be irritating to skin - Executive summary:
A study was performed to determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the Open Epicutaneous test (OET)
Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.
Based on these observations, the test chemical can be considered to be irritating to skin
Reference
After repeated application over 21 successive days
Concentration % |
Skin irritation after days |
||
7 |
14 |
21 |
|
60 |
(+) |
+ |
+ |
30 |
(+) |
+ |
+ |
10 |
(+) |
(+) |
(+) |
3 |
- |
(+) |
(+) |
Degree of skin irritation:
- = none
(+) = very slight
+ = slight
++ = moderate
+++ = strong
++++ = very strong
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals. The study 2,3 are referred as study 1,2
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1. 0.1 ml
2. 0.1 ml - Duration of treatment / exposure:
- single
- Observation period (in vivo):
- 1. 24, 48 and 72 hours
2. 1, 24, 48 and 72 h. - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1. 3
2. 4 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
The ocular irritation potential of the test chemical was assessed based on the available results from the various test chemicals.
Acute eye irritation study was carried out to assess the toxicity of the test chemical in rabbits. The study was performed according to the Fed. Reg. 38, No. 187, § 1500.42 Guidelines.
0.1 ml test chemical was instilled into the eyes of 3 Vienna White rabbits, and the untreated eye served as control. The treated eyes remained unwashed throughout the test. The treated eyes were graded according to Draize scale for opacity corneal, iritis, redness, chemosis, discharge at 24, 48 and 72 hours post instillation.
Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. These effects were fully reversible by 72 hours.
The test substance is considered to be non irritating to the eye. According to the conditions of the test, the test substance does not fullfil the criteria of 67/548/EEC and GHS UN for classification, respectively.
This is supported by the results of the other ocular irritation study performed in four female SPF albino rabbits for test chemical in order to determine the rritancy potency of the test chemical.
A 0.1 ml aliquot of undiluted test chemical was instilled into the left eye then gently closed for 1 s. The untreated right eye of each animal served as a control. Observations were made at 1, 24, 48 and 72 h. Slight to moderate conjunctive irritation (4/4) was observed 1 hour after application. All effects were reversible within 48 h.
As all the observed effects were not persisted after 48 hours, the test chemical was considered to be not irritating in four female SPF albino rabbits.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Various studies has been reviewed to determine the dermal irritation potential of the test chemical in living organisms. These include experimental in vivo experimental studies performed on guinea pigs, rabbits, humans for the test chemical.
A study was performed to determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the Open Epicutaneous test (OET)
Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.
Based on these observations, the test chemical can be considered to be irritating to skin.
This is supported by the results of the Standard Draize test performed to determine the irritation potential of the test chemical. Six rabbits were tested with intact skin and six with abraded skin.
500 mg of the test chemical caused well defined erythema and slight edema after 24 hours of exposure
Hence, the test chemical can be considered to be irritating to skin.
These results are supported by a pre-screen for a human maximization study, 5% test chemical in petrolatum (3450 microgram/cm2) was applied to the skin of human volunteers and observed for signs of irritation till 48 hours.
5% test chemical in petrolatum (3450 microgram/cm2) failed to cause irritation to human skin after 48 hours exposure.
Hence, the test chemical can be considered to be not irritating to skin.
For the same chemical, in a patch test study utilizing closed patches (vehicle not specified; concentration not specified, but between 0.05% and 5%) . Patches were applied under occlusion to the forearm of 465 Japanese Dermatology patients for 24–48 h and scored upon removal.
11 of 465 Japanese dermatology patients had a positive irritation reaction to the test chemical after 48 hours. Hence, the test chemical can be considered to be irritating to skin.
These results are supported by a study to determine the dermal irritation potential of the test chemical was assessed in rabbits.
Administration of the test chemical for 72 hrs to rabbit resulted in moderate irritating on repeated application especially to abraded skin.
Eventough the results of pre-screen test for human maximization test indicate a possibility of the test chemical being not irritating to skin, but the remaining studies suggest otherwise. Also, in the single and repeated exposure of the test chemical to skin, moderate irritation was observed. Taking into consideration, all these parameters, the test chemical can be considered to be irritating to skin. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Category 2”.
Eye Irritation
The ocular irritation potential of the test chemical was assessed based on the available results from the various test chemicals.
Acute eye irritation study was carried out to assess the toxicity of the test chemical in rabbits. The study was performed according to the Fed. Reg. 38, No. 187, § 1500.42 Guidelines.
0.1 ml test chemical was instilled into the eyes of 3 Vienna White rabbits, and the untreated eye served as control. The treated eyes remained unwashed throughout the test. The treated eyes were graded according to Draize scale for opacity corneal, iritis, redness, chemosis, discharge at 24, 48 and 72 hours post instillation.
Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. These effects were fully reversible by 72 hours.
The test substance is considered to be non irritating to the eye. According to the conditions of the test, the test substance does not fullfil the criteria of 67/548/EEC and GHS UN for classification, respectively.
This is supported by the results of the other ocular irritation study performed in four female SPF albino rabbits for test chemical in order to determine the rritancy potency of the test chemical.
A 0.1 ml aliquot of undiluted test chemical was instilled into the left eye then gently closed for 1 s. The untreated right eye of each animal served as a control. Observations were made at 1, 24, 48 and 72 h. Slight to moderate conjunctive irritation (4/4) was observed 1 hour after application. All effects were reversible within 48 h.
As all the observed effects were not persisted after 48 hours, the test chemical was considered to be not irritating in four female SPF albino rabbits.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Justification for classification or non-classification
Eventough the results of pre-screen test for human maximization test indicate a possibility of the test chemical being not irritating to skin, but the remaining studies suggest otherwise. Also, in the single and repeated exposure of the test chemical to skin, moderate irritation was observed. Taking into consideration, all these parameters, the test chemical can be considered to be irritating to skin. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Category 2”.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
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