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Diss Factsheets
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EC number: 204-508-5 | CAS number: 121-92-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods.
- Author:
- Gerberick GF, Ryan CA, Kern PS, Schlatter H, Dearman RJ, Kimber I, Patlewicz GY, Basketter DA.
- Year:
- 2 005
- Bibliographic source:
- Dermatitis, 2005 Dec; 16(4):157-202
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The skin sensitizing potential of the test chemical was assessed by using the Mouse Local Lymphnode Assay.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- salicylic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Salicylic acid
- Molecular formula :C7H6O3
- Molecular weight :138.1214 g/mol
- Substance type:organic
- Physical state:solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Source: No data
Age at study initiation: 7-12 weeks
ENVIRONMENTAL CONDITIONS: No data
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25 µl
- No. of animals per dose:
- no data available
- Details on study design:
- no data available
- Positive control substance(s):
- not specified
- Statistics:
- no data available
Results and discussion
- Positive control results:
- no data available
In vivo (LLNA)
Results
- Parameter:
- EC3
- Value:
- 0
- Test group / Remarks:
- test group
- Remarks on result:
- other: not sensitizing
- Cellular proliferation data / Observations:
- The relative potency index of the test chemical was not calculates since the SI were less than 3
Any other information on results incl. tables
Table 2: Results of the LLNA study
CAS |
Vehicle |
LLNA% |
LLNA% |
LLNA% |
LLNA% |
LLNA% |
LLNA SI |
LLNA SI |
LLNA SI |
LLNA SI |
LLNA SI |
LLNA EC3 |
Relative Potency |
69-72-7 |
AOO |
5 |
10 |
25 |
- |
- |
0.8 |
1.5 |
2.5 |
0 |
0 |
NC |
Non sensitizer |
Where AOO – Acetic acid in olive oil(4:1) ; SI - Stimulation Index; NC – Not calculated
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The relative potency index of the test chemical was not calculated since the SI were less than 3.
Based on the relative potency, the test chemical was considered to be not sensitizing to mice skin. - Executive summary:
The skin sensitizing potential of the test chemical was assessed by using the Mouse Local Lymphnode Assay. The study was conducted as per OECD 429 Guidelines.
The LLNA was conducted on groups of CBA mice (7-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl or to an equal volume of relevant vehicle (Acetic acid in olive oil (4:1))only. Treatment was performed daily for 3 consecutive days. Five days after initiation of exposure all mice were injected via the tail vein with 250µl of PBS containing 20µCi of tritiatied thymidine. The mice were sacrificed 5 hours later, and draining the auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by β-scintillation counting and was reported in disintegrations /minute. An SI was calculated for each chemical group as the ratio of disintegrations/minute of the treated group to the disintegrations/minute of the concurrent vehicle control group.
A substance was classified skin sensitizer, if at one or more than one concentrations, it induced a three-fold or greater increase in local lymph node proliferative activity when treated with the concurrent vehicle treated controls (SI ≥3) The approach to estimation of the relative skin sensitization potential is based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value.
The relative potency index of the test chemical was not calculated since the SI were less than 3.
Based on the relative potency, the test chemical was considered to be not sensitizing to mice skin.
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