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EC number: 221-576-1 | CAS number: 3148-73-0
- 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: not corrosive, Transcutaneous electrical resistance test (TER), similar to OECD 430, Pooles 2004c
- Eye: not irritating, enucleated rabbit eyes, method described by Burton et al. (1981), Pooles 2004d
- Eye: not irritating, male, rabbit, OECD 405, Pooles 2004e
- Respiratory: no study available
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 2004-02-26 to 2004-03-02 (experimental phase)
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is a screening study which did not formally follow a guideline method, and was not formally performed under audited GLP, however, the laboratory facilities were operated according to GLP. The purity of the test material was not reported and the documentation in the report was very limited. Although the results are considered valid, the screening study itself cannot be considered formally reliable due to the lack of formal guideline, quality assurance, and very limited documentation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
- Species:
- rat
- Strain:
- Wistar
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: The substance is considered likely to be corrosive in vivo if the mean electrical resistance is below 5kΩ. - Irritation parameter:
- other: electrical resistance (kΩ)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 29.6
- Remarks on result:
- other: Standard deviation: 4.7 kΩ. Values below 5kΩ are considered to be corrosive.
- Irritant / corrosive response data:
- The measured mean electrical resistance was 29.6 ± 4.7 kΩ.
- Interpretation of results:
- other: not corrosive (skin corrosive category 1)
- Conclusions:
- Although the result is considered to be valid, due to the lack of formal guideline and quality assurance, and very limited documentation, it must be regarded as not being reliable.
- Executive summary:
The skin corrosivity potential of the test material was assessed using the Transcutaneous Electrical Resistance Assay (TER). This involved the application of the test material to the epidermal surface of skin discs, obtained from a humanely killed young Wistar strain rat.
The prepared pelt from the rat was used for skin disc preparation. The test material was applied to the epidermal surface of three skin discs for a contact period of 24 hours. At the end of the contact period the test material was removed using a jet of warm tap water. Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent TER. A threshold value has been established (5 kΩ) below which materials are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.
The measured mean electrcal resistance was 29.6 ± 4.7 kΩ and thus, the test material was considered not to have the potential to be corrosive to the skin in vivo under the conditions of the test.
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:
- supporting study
- Study period:
- from 2004-03-15 to 2004-03-25 (experimental phase)
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is a screening study which was not formally performed under audited GLP, however, the laboratory facilities were operated according to GLP. The purity of the test material was not reported and the documentation in the report was very limited. All raw data (observations) were reported. Although the results are considered valid, the screening study itself cannot be considered formally reliable due to the lack of quality assurance, and very limited documentation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No details on test animals and environmental conditions are reported.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (81 mg) - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- Ocular reactions were recorded 1, 24,48 and 72 hours after administration.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: not reported - Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not considered to be an eye irritant according to the criteria set out in Regulation (EC) No 1272/2008. Although the result is considered to be valid, due to the lack of quality assurance, and very limited documentation, it should be regarded as not being reliable.
- Executive summary:
A study was preformed to assess the irritation of the test material to the eye of rabbits. The method followed OECD TG 405.
A single application of 0.1 mL (81 mg) test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.
The test material produced minimal conjunctival irritaiton. All treated eyes appeared normal at the 48-hour observations.
Reference
Individual Scores and Individual Total Scores for Ocular Irriation
Rabbit number and sex |
38 Male |
52 Male |
157 Male |
|||||||||
Initial Pain Reaction = 3 |
Initial Pain Reaction = 0 * |
Initial Pain Reaction = 0 * |
||||||||||
Time after treatment [h] |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea |
||||||||||||
E=Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F=Area of Cornea involved |
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 |
||||||||||||
A=Redness |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
B=Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C=Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
4 |
0 |
0 |
0 |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
Total Score |
4 |
0 |
0 |
0 |
4 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
* One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation / Corrosion
A single study addressing skin corrosion was available (Pooles, 2004c). The test material was considered not to have the potential to be corrosive to the skin in vivo under the conditions of the study. The study is considered to be relevant.
The TER assay allows the positive identification of corrosive chemical substances, and it further allows the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information (e.g. pH, structure activity-relationships, human and/or animal data). It does not provide information on skin irritation, nor does it allow the sub-categorisation of corrosive substances as permitted in the Globally Harmonised System for Hazard Classification and Labelling.
The available data is considered to be relevant and adequate for classification and risk assessment purposes, but not reliable because the study was not performed according to a recognised guideline, nor under GLP, or with sufficient documentation. Although the results are regarded as valid, the endpoint is not considered to be conclusive for skin irritation.
Eye Irritation
Two studies were available addressing eye irritation (Pooles, 2004d and Pooles, 2004e). Pooles (2004d) used the protocol for the rabbit enucleated eye test. This test permits evaluation of undiluted test materials, as they could enter the in-vivo eye test, and hence may be seen advantageous over a number of other in-vitro test systems. The test will not provide information, however, about potential effects of a test material on the conjunctivae, nor about the rate of recovery from an insult. Based on the outcomes of the test the substance was considered unlikely to have the potential to cause severe ocular irritancy in vivo. The study is relevant, but not adequate for classification purposes.
A second study by Pooles (2004e) followed OECD TG 405. A single application of 0.1 mL (81 mg) test material was administered to the non irrigated eye of three New Zealand White rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration. The test material produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observations.
The study is considered to be relevant and adequate for classification and risk assessment purposes, but not reliable because the study was not performed under GLP, or with sufficient documentation. Although the results are regarded as valid, the endpoint is not considered to be conclusive for eye irritation.
Respiratory Irritation
No data on respiratory irritation was available.
Justification for selection of skin irritation / corrosion endpoint:
Only study available.
Justification for selection of eye irritation endpoint:
The in vivo study provides full information on all the criteria necessary for classification purposes, whereas the in vitro study is only addresses some aspects, and cannot be used to derive a conclusive non-classification.
Justification for classification or non-classification
Skin
The substance was tested with a method comparable to OECD TG 430, and found to be not corrosive to skin. The TER assay allows the positive identification of corrosive chemical substances, and it further allows the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information (e.g. pH, structure activity-relationships, human and/or animal data). It does not provide information on skin irritation, nor does it allow the sub-categorisation of corrosive substances as permitted in the Globally Harmonised System for Hazard Classification and Labelling. The substancedoes not meet the criteria for classification as corrosive to the skin according to Directive 2001/59/EC, Annex VI, or classified as irritating to the skin according to Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2. Because the study is not validated for all classifications, it is not regarded as adequate for classification purposes. In addition the study is not considered reliable. As a result, this endpoint is considered to be not classified, but inconclusive.
Eye
An in-vitro study on the eye irritation potential of the test substance was performed by using the protocol for the rabbit enucleated eye test, and found thatthe test substance was unlikely to have the potential to cause severe ocular irritancy in vivo. The second study (Pooles, 2004e), an in vivo OECD TG 405, found the test material produced minimal conjunctival irritation, and all treated eyes appeared normal in the 48-hour observation. As a result, the substance is not considered to be classified according to the criteria set out inDirective 2001/59/EC, Annex VI,or according to Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2. Because the in vivo study is not regarded as reliable, this classification is considered to be inconclusive.
Inhalation
No data available.
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