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EC number: 903-161-3 | 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 sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 February to 13 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with current guidelines and GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate
- Age at study initiation: between 7 and 9 weeks old
- Weight at study initiation: 16 to 19 g
- Housing: In pairs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 22°C
- Humidity (%): 48% to 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To: 01 to 13 February 2012 - Vehicle:
- other: maize oil
- Concentration:
- 0%, 2.5%, 10% and 50%
- No. of animals per dose:
- 6 at 0% and 4 at each of 2.5%, 10% and 50%
- Details on study design:
- RANGE FINDING TESTS:
- Irritation and toxicity
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay: dermal application
- Criteria used to consider a positive response: Stimulation indices greater than or equal to 3 in groups treated at either 2.5%, 10% or 50%
TREATMENT PREPARATION AND ADMINISTRATION: No preparation. Dermal application to the dorsum of the ears - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Dixon's Q-test for the detection of a single outlier was performed on disintegrations per minute values
- Positive control results:
- Stimulation index = 8.09
- Parameter:
- SI
- Value:
- 2.02
- Test group / Remarks:
- 4 animals, 2.5% concentration
- Parameter:
- SI
- Value:
- 1.16
- Test group / Remarks:
- 4 animals, 10% concentration
- Parameter:
- SI
- Value:
- 2.89
- Test group / Remarks:
- 4 animals, 50% concentration
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, since treatment with EC 903 161 3 at concentrations of up to 50% did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.
This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes. - Executive summary:
The objective of this study was to determine the delayed contact hypersensitivity potential of EC-903-161-3.
The study was performed using female CBA/Ca mice. The study design for the main study was as follows:
Text Table1
Experimental DesignStudy Number
Group Number
Treatment
Formulation Concentration (%)
Animal Numbers
521627
1
Vehicle Control
0
1 to 6
521627
5
HCA
50
49 to 52
521674
1
EC-903-161-3
2.5
21 to 24
521674
2
EC-903-161-3
10
25 to 28
521674
3
EC-903-161-3
50
29 to 32
The stimulation indices (SI) for groups of mice that received EC-903-161-3 at concentrations of 2.5%, 10% or 50%, when compared with controls, were 2.02, 1.16 and 2.89, respectively.
Under the conditions of the study, since treatment with EC-903-161-3 at concentrations of up to 50% did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a study conducted in accordance with the OECD 429 guideline, the substance was tested for skin sensitisation potential in the mouse local lymph node assay.The Stimulation Index did not exceed 3 in any treatment group; therefore, the test material was considered to be a non-sensitizer under the conditions of the test.
Migrated from Short description of key information:
The substance is not a skin sensitizer based on the results of a Local Lymph Node Assay.
Justification for selection of skin sensitisation endpoint:
Key study conducted in accordance with OECD guideline and GLP standards.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Based on the result of the LLNA study conducted in accordance with the OECD 429 guideline, the test material does not meet the criteria for classification as a skin sensitizer under the terms of the CLP Regulation (EC) No 1272/2008.
Justification for classification or non-classification
Based on the result of the LLNA study the test material does not meet the criteria for classification as a skin sensitizer under the terms of the CLP Regulation (EC) No 1272/2008.
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