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Diss Factsheets
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EC number: 943-554-7 | CAS number: -
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3-9 June 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Pre-incubated overnight (guideline recommends 18-24 h)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: human derived epidermal keratinocytes
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SkinEthic Laboratories, Lyon, France
- Age at study initiation: Not applicable
- Weight at study initiation: Not applicable
- Housing: Not applicable
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not applicable
- Humidity (%): Not applicable
- Air changes (per hr): Not applicable
- Photoperiod (hrs dark / hrs light): Not applicable
IN-LIFE DATES: From: 3 June 2014 To: 9 June 2014 - Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 μL (26.3 μL/cm squared)
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 hours post-exposure incubation period
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm squared
- % coverage: Not applicable
- Type of wrap if used: Not applicable
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM: Not applicable - Irritation / corrosion parameter:
- other: other: Relative viability (test item)
- Value:
- 7.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (test item)
- Value:
- 0.078
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative viability (positive control)
- Value:
- 6.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (positive control)
- Value:
- 0.068
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative viability (negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (negative control)
- Value:
- 1.09
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: EU
- Conclusions:
- In a guideline study (OECD TG 439), to GLP, the dermal irritation of azarbre was assessed using the in vitro human epidermis model. The test item was classified as irritant according to EU labelling regulations.
- Executive summary:
In an OECD guideline study (TG 439), conducted according to GLP, the dermal irritation of azarbre was assessed using the in vitro human epidermis model. The quality acceptance criteria were satisfied for both the positive and negative controls and for the test matieral. The relative mean tissue viability of the test item was less than 50% of the negative control (7.2%) and was therefore classified as a category 2 irritant according to EU labelling regulations.
Reference
Item | OD of tissues | Mean OD | ± SD of OD | Relative individual tissue viability | Relative mean viability/% | ± SD of Relative mean viability/% |
Negative control | 1.138 | 1.090 | 0.049 | 104.4 | 100 | 4.5 |
1.040 | 95.4 | |||||
1.093 | 100.3 | |||||
Positive control | 0.083 | 0.068 | 0.028 | 7.6 | 6.2 | 2.6 |
0.035 | 3.2 | |||||
0.085 | 7.8 | |||||
Test material | 0.060 | 0.078 | 0.031 | 5.5 | 7.2 | 2.9 |
0.060 | 5.5 | |||||
0.114 | 10.5 |
Mean optical density (OD) values, percentage viabilities and standard deviations (SD) for the negative control, positive control and test material. Mean viabilities are measured relative to the negative control (i.e. this is set at 100%).
The relative mean tissue viability for the positive control was 6.2% compared to the negative control, with a standard deviation of 2.6%. The mean optical density for the negative control was 1.090 and the standard deviation of the percentage viability was 4.5%. The standard deviation of the three test percentage viabilities was 2.9%. The acceptance criteria for negative, positive and test material were therefore satisfied.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to guideline. In compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Chicken
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The eyes used in this assay were collected from c hickens obtained from a slaughterhouse (Etablissement Brun, 338 Etauliers, France) where they were killed for human consumption. Chicken age was generally 7 weeks old.
The eyes of the chickens were enucleated at Phycher. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 30uL of test item was applied
- Duration of treatment / exposure:
- The test item was applied for 10 seconds so that it covered the entire surface of the cornea evenly. It was then rinsed from the eye with 20mL of physiological saline at ambient templerature.
- Observation period (in vivo):
- Treated corneas were evaluated pretreatment and after treatment 30, 75, 120, 180 and 240 minutes (+/- 5 minutes).
- Number of animals or in vitro replicates:
- 3 enucleated chicken eyes
- Details on study design:
- Negative controls (physiological saline) and positive controls (5% Benzalkonium chloride) were included in this experiment.
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- Corneal Opacity
- Basis:
- mean
- Score:
- ca. 1.3
- Remarks on result:
- other: Corresponds to ICE class II
- Irritation parameter:
- other: Mean score of fluorescein retention
- Basis:
- mean
- Score:
- ca. 0.7
- Remarks on result:
- other: Corresponds to ICE class II
- Irritation parameter:
- cornea opacity score
- Remarks:
- Maximal mean corneal swelling
- Basis:
- mean
- Time point:
- other: 240 minutes post-dose
- Score:
- ca. 12
- Remarks on result:
- other: Corresponds to ICE class II
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The results obtained under the experimental conditions described, lead to the conclusion that Azarbre is not a corrosive / severe irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Reliable in vitro K1 study
Justification for selection of eye irritation endpoint:
Reliable in vitro K1 study
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Skin irritation not observed and therefore no classification required.
Eye irrtation was observed and the following classification apply:
EU DSD (67 -548 -EEC) Irritant requires symbol "Xi" risk phrase R38 "Irritating to Skin"
EU CLP and UN GHS Hazard statement H315 "Causes Skin Irritation" Category 2
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