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EC number: 209-091-3 | CAS number: 555-32-8
- 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
A KeratinoSens™ assay was performed according to OECD guideline and GLP principles, which was inconclusive. All available non-animal data were evaluated and it was concluded that an in vivo skin sensitisation test had to be performed. An in vivo skin sensitisation study was performed according to OECD test guide 429 and GLP principles, based on which it was concluded that aluminium tribenzoate has no skin sensitising properties.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 December 2017 - 09 Januari 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Aluminium tribenzoate is a salt which dissociates to benzoate and aluminium ions in aqueous solution. The available information on benzoate does not indicate that this ion has skins sensitising properties. For aluminium, the available information was less conclusive. Both DEREK assessment and the DPRA assay are not suitable to address skin sensitizing potential of metals, so in this case these tests were not considered relevant since the aluminium ion was the main focus of the assessment. A KeratinoSensTM assay was performed in accordance with Section 8.3 of Annex VII of Regulation (EC) No 1907/2006 as amended in Commission Regulation (EU) 2016/1688 of 20 September 2016 and the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a. Aluminium tribenzoate is classified as inconclusive in the KeratinoSensTM assay since negative results (<1.5-fold induction, no activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) were observed at test concentrations <1000 μM and cell viability >70%. Performance of an additional in vitro test was considered, however both a negative result and a positive outcome would result in the necessity to further address the skin sensitizing properties in vivo. It was considered scientifically justified to omit further in vitro test work and to proceed with an in vivo test. The full assessment is attached.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (July 2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (March 2003)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: Young adult animals (approx.12 weeks old)
- Weight at study initiation: 18.8 - 24.4 g
- Housing: Animals were group (max 5) housed in labeled Makrolon cages.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 22
- Humidity (%): 42 - 55
- Air changes (per hr): ten or more
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 December 2017 - 08 Januari 2018 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 5, 10, 25% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Two test item concentrations were tested; a 10% and 25% concentration. The highest concentration was the maximum concentration that could technically be applied.
The test system, procedures and techniques were identical to those used in the main study except that the animals were approximately 11 weeks (at initiation of treatment) and that the assessment of lymph node proliferation and necropsy were not performed. Two young adult animals per concentration were selected. Each animal was treated with one concentration on three consecutive days. Animals were group housed in labeled Makrolon cages. Ear thickness measurements were conducted using a digital thickness gauge prior to dosing on Days 1 and 3, and on Day 6.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer, based on the test guideline and recommendations done by ICCVAM.
ANIMAL ASSIGNMENT
Three groups of five animals were treated with one test substance concentration per group. One group of five animals was treated with vehicle.
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance preparation:
Test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations were prepared daily and dosed within 4 hours after adding the vehicle to the test item.
The dosing formulations were kept at room temperature until dosing. The dosing formulations were stirred until and during dosing.
No adjustment was made for specific gravity of the vehicle and no correction was made for the purity/composition of the test item, since the test method requires a logical concentration range rather than specific dose levels.
Rationale for vehicle: The vehicle was selected based on trial formulations performed at Charles River Den Bosch and on test substance data supplied by the sponsor.
Induction - Days 1, 2 and 3; Excision of nodes - Day 6; Tissue processing for radioacitivity - Day 6; Radioactivity measurements - Day 7; Performed according to test guidelines.
Observations:
Mortality/Viability: Twice daily.
Body weights: On Day 1 (pre-dose) and Day 6 (prior to necropsy).
Clinical signs: Once daily on Days 1-6 (on Days 1-3 between 3 and 4 hours after dosing).
Irritation: Once daily on Days 1-6 (on Days 1 - 3 immediately after dosing) according to a numerical scoring system. Furthermore, a description of all other (local) effects was recorded according to guidelines.
Necropsy: No necropsy was performed, since all animals survived until the end of the observation period. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
- Positive control results:
- The six-month reliability check with Alpha-hexylcinnamicaldehyde shows that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity.
- Key result
- Parameter:
- SI
- Value:
- 2.4
- Remarks on result:
- other: Test item concentration: 5%
- Key result
- Parameter:
- SI
- Value:
- 1.5
- Remarks on result:
- other: Test item concentration: 10%
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Remarks on result:
- other: Test item concentration: 25%, the highest concentration technically achievable.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an LLNA skin sensitisation study, performed according to OECD test guide 429, aluminium tribenzoate was considered not to be a skin sensitiser, as the SI appeared not to be ≥ 3 when tested up to 25% (w/w), the highest concentration technically achievable.
- Executive summary:
An LLNA skin sensitisation study was performed according to OECD/EC test guidelines and GLP principles. Based on the results of a pre-screen test, the test concentrations were selected at 5%, 10% and 25% (w/w), the highest concentration technically possible. In the main study a very slight erythema was noted for one animal treated at 25% on day 3. This was considered not to have a toxicologically significant effect on the activity of the nodes. White test item remnants were present on the dorsal surface of the ears of the test item treated animals between Days 1 and 6, which did not hamper scoring of the skin reactions.The majority of auricular lymph nodes were considered normal in size, except for one of the nodes in one animal treated at 5%, which was considered to be enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Mean DPM/animal values for the experimental groups treated with test item concentrations 5, 10 and 25% were 785, 514 and 215 DPM, respectively. The mean DPM/animal value for the vehicle control group was 333 DPM. The SI values calculated for the test item concentrations 5, 10 and 25% were 2.4, 1.5 and 0.6, respectively. As the SI appeared not to be ≥ 3 when tested up to 25% (w/w), aluminium tribenzoate was considered not to be a skin sensitiser.
Reference
Results Pre-screen test:
At a 10% and 25% test item concentration, no erythema or signs of toxicity were noted. Variation in ear thickness during the observation period were more than 25% from day 1 pre-dose values for one animal at 10%. Since ear thickness measurements were not conclusive, 25% was selected as the highest concentration to be used in the main study and ear thickness measurements were added to the main study.
Other results - main study:
Very slight erythema was noted for one animal treated at 25% on day 3, this was considered not to have a toxicologically significant effect on the activity of the nodes.
White test item remnants were present on the dorsal surface of the ears of the test item treated animals between days 1 and 6, which did not hamper scoring of the skin reactions.
The majority of auricular lymph nodes were considered normal in size, except for one of the nodes in one animal treated at 5%, which was considered to be enlarged.
No macroscopic abnormalities of the surrounding area were noted for any of the animals.
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Mean DPM/animal values: concentrations 0, 5, 10 and 25% were 333, 785, 514 and 215 DPM, respectively. The SI values calculated for the test item concentrations 5, 10 and 25% were 2.4, 1.5 and 0.6, respectively.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An LLNA skin sensitisation study was performed according to OECD/EC test guidelines and GLP principles. Based on the results of a pre-screen test, the test concentrations were selected at 5%, 10% and 25% (w/w),the highest concentration technically possible. In the main study a very slight erythema was noted for one animal treated at 25% on day 3. This was considered not to have a toxicologically significant effect on the activity of the nodes.White test item remnants were present on the dorsal surface of the ears of the test item treated animals between Days 1 and 6, which did not hamper scoring of the skin reactions.The majority of auricular lymph nodes were considered normal in size, except for one of the nodes in one animal treated at 5%, which was considered to be enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.Mean DPM/animal values for the experimental groups treated with test item concentrations 5, 10 and 25% were 785, 514 and 215 DPM, respectively. The mean DPM/animal value for the vehicle control group was 333 DPM. The SI values calculated for the test item concentrations 5, 10 and 25% were 2.4, 1.5 and 0.6, respectively. As the SI appeared not to be ≥ 3 when tested up to 25% (w/w), aluminium tribenzoatewas considered not to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, aluminium tribenzoate is not classified for skin sensitisation according to CLP Regulation (EC) No. 1272/2008.
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