Registration Dossier
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EC number: 700-323-3 | CAS number: 908020-52-0
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TNO Quality of Life, Zeist, The Netherlands
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Perfluoro-3,6-dioxaoctanoic acid ammonium salt (EEA-NH4)
- Physical state: white powder
- Analytical purity: 99%
- Lot/batch No.: #070921
- Storage condition of test material: room temperature
- Specific activity (if radiolabelling): 185 GBq/mmol
- Locations of the label (if radiolabelling): lymph nodes
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, The Netherlands
- Age at study initiation: 6-10 weeks
- Weight at study initiation: unknown
- Housing: From arrival until allocation, group housing in macrolon cages (Type VI, maximally 5/cage). After allocation the animals were housed individually (macrolon Type II cages).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 (7:00 to 19:00 light)
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50% w/v
- No. of animals per dose:
- five
- Details on study design:
- Three groups of 5 animals each were treated with increasing concentrations of EEA-NH4 (10%, 25% and 50% in vehicle (w/v), respectively) applied on the dorsum of both ears (25 µL per ear) for three consecutive days. Three days after the last treatment, all animals received an intravenous injection of 3H thymidine. Five hours later, the 3H-thymidine incorporation in the draining auricular lymph nodes was determined. The results were compared with those of a control group which was treated with the vehicle (acetone/olive oil, 4:1 v/v). A positive control group treated with Hexyl Cinnamic Aldehyde (a 25% HCA solution in vehicle) was included in the study as a reliability check.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical evaluation of the data (body weights and 3H-thymidine incorporation) was performed by analysis of variance followed by a Dunnett’s multiple comparison tests. 3H-thymidine incorporation of treatment groups 2, 3 and 4 were compared to vehicle-treated animals. The validity of the model was tested by comparing the positive control and the vehicle-treated group. Probability values of p<0.05 were considered significant.
Results and discussion
- Positive control results:
- No signs of irritation were observed after three consecutive applications of a 25% concentration of HCA in all animals. 3H-thymidine incorporation in the auricular lymph nodes was statistically significantly enhanced in comparison with the vehicle controls. The calculated stimulation index of 4.0 supported this observation and demonstrated the sensitivity of the test system and validity of the model.
Disintegrations per minute: 16475.5
Stimulation index: 4.0
Result: positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (% w/v) Stimulation index Result 0 1.0 - 10 1.1 negative 25 2.2 negative 50 1.9 negative
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (% w/v) Disintegrations per minute 0 4137.1 10 4562.3 25 9113.3 50 7877.1
Any other information on results incl. tables
3H-thymidine incorporation in the auricular lymph nodes in animals treated with a 10% concentration EEA-NH4 was similar to that in vehicle control animals, whereas3H‑thymidine incorporation was statistically significantly enhanced at 25% and 50% concentrations. Stimulation indices (SI’s) of 1.1, 2.2 and 1.9 were calculated in response to a 10%, 25% and 50% EEA-NH4 concentration respectively. Since the SI’s were lower than 3 at all concentrations the results indicated that EEA-NH4 should not be considered a skin sensitiser (a SI of 3 is the limiting value required for classification as a skin sensitiser).
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